Not provided
Not provided
Not provided
Not provided
Not provided
The trial was prematurely discontinued due to the financial situation of the sponsor and not for safety or efficacy reasons.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
AFM24-102 is a Phase 1/2a open-label, non-randomized, multicenter, dose escalation, and expansion study evaluating AFM24 in combination with atezolizumab in patients with selected EGRF-expressing advanced solid malignancies whose disease has progressed after treatment with previous anticancer therapies.
There will be 2 parts in this study: a dose escalation phase (phase 1) and an expansion phase (phase 2a). Patients will qualify to receive the investigational drugs (AFM24 + atezolizumab) in the dose escalation phase or the expansion phase only if they are deemed eligible following the safety lead-in phase. Seven days before the planned first combination treatment, patients will receive a single dose of AFM24 and will be observed for any adverse events for 1 week.
The aim of the dose escalation phase is to determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of AFM24 in combination with atezolizumab.
The dose escalation phase will be followed by the expansion phase once the MTD/RP2D of AFM24 in combination with atezolizumab has been determined. The expansion phase of the study is intended to collect preliminary evidence of efficacy and to further confirm the safety of AFM24 in combination with atezolizumab.
The tumor types planned to be studied in the AFM24/atezolizumab combination study will be:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Escalation Phase | Experimental | The Escalation phase will determine the MTD/RP2D of AFM24 in combination with atezolizumab. A traditional 3+3 design will be used to determine the RP2D. |
|
| Expansion Phase | Experimental | The expansion phase will collect preliminary evidence of efficacy and further confirm the safety of AFM24 in combination with atezolizumab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AFM24 | Drug | intravenous infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Incidence of Dose Limiting Toxicities (DLTs) During Cycle 1 | The number of patients with dose limiting toxicities (DLTs) in the first cycle, as assessed by the National Cancer Institute Common Technology Criteria for Adverse Events (CTCAE) v5.0 | During cycle 1 (each cycle has 28 days) |
| Phase 2a: Overall Response Rate (Complete Response [CR] or Partial Response [PR]) | Tumor assessment by RECIST v1.1 by investigator. Best overall response was used to define the Overall Response Rate (CR or PR). Best overall response is CR or PR if a CR or PR assessed at least 42 days after Cycle 1 Day 1 was confirmed by subsequent tumor assessment at least 4 weeks later. | Tumor assessments were conducted during last week of cycle 2, 4, 6, 8, 10, 12 and every 3 cycles thereafter (each cycle has 28 days), up to approximately 97 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Patients With TEAEs | Number of patients with treatment-emergent adverse events (TEAEs) non-serious or serious | From first drug administration up to 30 (non-serious TEAEs) or 56 (serious TEAEs) days after last dose AFM24, until start of a subsequent anticancer treatment, or data cut-off date, whichever is sooner. Up to approx. 35 (phase 1) and 105 weeks (phase 2a). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Daniela Morales-Espinosa, MD | Affimed GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States | ||
| University of Chicago Medical Center |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1 - Cohort 1 - AFM24 160 mg + Atezolizumab 840 mg | Patients aged 18 years or older with documented histologically or cytologically confirmed select advanced or metastatic epidermal growth factor receptor (EGFR)-positive cancers. The patients received AFM24 160 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 10, 2023 | Jul 21, 2025 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Atezolizumab 840 MG in 14 ML Injection |
| Drug |
intravenous infusion |
|
| Incidence of Patients With SAEs | Number of patients with treatment-emergent serious adverse events (serious TEAEs) | From first drug administration up to 56 days after the last dose of AFM24, until the start of a subsequent anticancer treatment, or data cut-off date, whichever is sooner. Up to approximately 35 (phase 1) and 105 weeks (phase 2a). |
| Pharmacokinetics (PK) of AFM24 | Maximum plasma concentration (Cmax) on Cycle 1 Day 22 | During cycle 1 (each cycle has 28 days) |
| Pharmacokinetics (PK) of AFM24 | Minimum plasma concentration (Cmin) Corresponding to Ctrough levels at the end of the dosing interval at Cycle 1 Day 22 | During cycle 1 (each cycle has 28 days) |
| Pharmacokinetics (PK) of AFM24 | Area under the concentration-time curve over the dose interval (AUCtau) on Cycle 1 Day 22 | During cycle 1 (each cycle has 28 days) |
| Pharmacokinetics (PK) of AFM24 | Time to Cmax (Tmax) on Cycle 1 Day 22 | During cycle 1 (each cycle has 28 days) |
| Frequency of Patients Developing Anti-drug Antibodies (ADAs) Against AFM24 | Measurement of ADAs before and during treatment with AFM24 in combination with atezolizumab Patients with at least one ADA-positive result at baseline or post-baseline counted as developing anti-drug antibodies (ADAs) against AFM24 | Ph 1 within 2h prior to: each drug intake (Cycle 1), 1st + 3rd drug intake (Cycle 2 onwards) and at EOT, up to 27 weeks. Ph 2a within 2h prior to: 1st drug intake (Cycle 1 and Cycle 3 onwards), 1st + 3rd drug intake (Cycle 2) and at EOT, up to 97 weeks. |
| Phase 1: Overall Response Rate (Complete Response [CR] or Partial Response [PR]) | Tumor assessment by RECIST v1.1 by investigator. Best overall response was used to define the Overall Response Rate (CR or PR). Best overall response is CR or PR if a CR or PR assessed at least 42 days after Cycle 1 Day 1 was confirmed by subsequent tumor assessment at least 4 weeks later. | Tumor assessments were conducted during last week of cycle 2, 4, 6, 8, 10, 12 and every 3 cycles thereafter (each cycle has 28 days), up to approximately 27 weeks. |
| Phase 2a: Progression-free Survival | Progression-Free Survival (PFS) was defined as (date of first progression - date of first study drug injection)/30.4375. Patients without progression or death were censored. Tumor assessment by RECIST v1.1 by investigator. | From the first treatment received until the first progression disease assessed by investigator or death. |
| Phase 2a: Duration of Response | Duration of Response (DOR) was defined as (date of first progression or death - date of first response (unconfirmed))/30.4375. Patients without response were excluded from the analysis. Patients without progression or death were censored. Tumor assessment by RECIST v1.1 by investigator. | From the date of first response (unconfirmed) until progression disease assessed by investigator or death. |
| Phase 2a: Clinical Benefit Rate (CR or PR [Any Duration] or Stable Disease Equal or > 24 Weeks) | Tumor assessment by RECIST v1.1 by investigator. Best overall response was used to define the Clinical benefit rate (CR or PR or SD ≥24 weeks). Best overall response is CR or PR if a CR or PR assessed at least 42 days after Cycle 1 Day 1 was confirmed by subsequent tumor assessment at least 4 weeks later. Best overall response is SD if SD or unconfirmed CR or unconfirmed PR at least 42 days after C1D1. Best overall response SD counts for Clinical benefit rate if SD ongoing for at least 24 weeks. | Tumor assessments were conducted during last week of cycle 2, 4, 6, 8, 10, 12 and every 3 cycles thereafter (each cycle has 28 days), up to approximately 97 weeks. |
| Phase 2a: Disease Control Rate (DCR) (Complete Response [CR] or Partial Response [PR] or Stable Disease [SD]) | Tumor assessment by RECIST v1.1 by investigator. Best overall response was used to define the Disease Control Rate (CR or PR or SD). Best overall response is CR or PR if a CR or PR assessed at least 42 days after Cycle 1 Day 1 was confirmed by subsequent tumor assessment at least 4 weeks later. Best overall response is SD if SD or unconfirmed CR or unconfirmed PR at least 42 days after C1D1. | Tumor assessments were conducted during last week of cycle 2, 4, 6, 8, 10, 12 and every 3 cycles thereafter (each cycle has 28 days), up to approximately 97 weeks. |
| Chicago |
| Illinois |
| 60637 |
| United States |
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| Independent Public Teaching Hospital #4 in Lublin, Department of Clinical Oncology and Chemotherapy | Lublin | 20-954 | Poland |
| European Health Center Otwock Fryderyk Chopin Hospital, Department of Clinical Oncology | Otwock | 05-400 | Poland |
| MED-Polonia, Sp. z o.o. (LLC) | Poznan | 60-693 | Poland |
| Janusz Korczak Provincial Specialist Hospital in Slupsk Limited Liability Company | SÅ‚upsk | 76-200 | Poland |
| Maria Sklodowska-Curie - National Research Institute of Oncology, Early Phase Research Department | Warsaw | 02-781 | Poland |
| Seoul National University Bundang Hospital | Seongnam-si | 13620 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| The Catholic University of Korea St. Vincent's Hospital | Suwon | 93 | South Korea |
| Vall d'Hebron Institute of Oncology (VHIO) | Barcelona | 08035 | Spain |
| University Hospital Quiron Madrid | Madrid | 28223 | Spain |
| University Clinic of Navarra - Pamplona | Pamplona | 31008 | Spain |
| Hospital Clinic Universitario Biomedical Research institute INCLIVA | Valencia | 46010 | Spain |
| Royal Marsden NHS Foundation Trust - ICR | Sutton | SM2 5PT | United Kingdom |
| FG001 | Phase 1 - Cohort 2 - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with documented histologically or cytologically confirmed select advanced or metastatic epidermal growth factor receptor (EGFR)-positive cancers. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
| FG002 | Phase 2 - Coh. EXP-1 (EGFR-WT NSCLC) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with advanced or metastatic, EGFR-WT expressing NSCLC whose disease has progressed after having received ≥1 prior lines of therapy for advanced disease. Patients must have received at least a platinum-based doublet in combination with an anti--programmed cell death protein 1 (PD1)/programmed death-ligand 1 (PD-L1) antibody or must have received an anti-PD1/PD-L1 antibody prior to or after a platinum-based doublet. Patients with a known actionable driver mutation (other than EGFR mutation) must have received an approved targeted treatment for the respective mutation. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the standard of care (SOC) is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
| FG003 | Phase 2 - Coh. EXP-2 (Gastric or GEJ Adenocarcinoma) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with locally advanced, unresectable, or metastatic gastric or GEJ adenocarcinoma refractory to or, intolerant of, standard therapy. Patients must have received ≥1 prior chemotherapy regimen including a platinum and fluoropyrimidine doublet. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
| FG004 | Phase 2 - Coh. EXP-3 (Hepatocellular,Hepatobiliary,Pancreatic) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with advanced or metastatic hepatocellular carcinoma (other than fibrolamellar and sarcomatoid subtype; Barcelona Clinic Liver Cancer Stage C disease or Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy), hepatobiliary-, or pancreatic adenocarcinoma. Patients must have been treated with at least 1 previous line of an approved, SOC therapy for the respective disease type or, in the opinion of the Investigator, available SOC is not appropriate. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
| FG005 | Phase 2 - Coh. EXP-4 (EGFR Kinase Domain Mutation NSCLC) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with advanced or metastatic NSCLC harboring a targetable EGFR kinase domain mutation and whose disease has progressed on or after having received ≥1 prior lines of therapy for advanced disease including ≥1 prior tyrosine kinase inhibitor (TKI) approved for EGFR mutated NSCLC, such as gefitinib, erlotinib, afatinib, dacomitinib or osimertinib. Patients who were treated with a 1st or 2nd generation TKI in 1st line and developed a documented T790M mutation must have received a TKI targeting this mutation such as osimertinib or lazertinib to be eligible. Patients must have documentation of EGFR mutated NSCLC as assessed by an approved test using genomic sequencing of tumor or circulating free tumor DNA. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Analysis Set (SAS): All patients who received at least any amount of AFM24 or atezolizumab
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1 - Cohort 1 - AFM24 160 mg + Atezolizumab 840 mg | Patients aged 18 years or older with documented histologically or cytologically confirmed select advanced or metastatic epidermal growth factor receptor (EGFR)-positive cancers. The patients received AFM24 160 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
| BG001 | Phase 1 - Cohort 2 - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with documented histologically or cytologically confirmed select advanced or metastatic epidermal growth factor receptor (EGFR)-positive cancers. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
| BG002 | Phase 2 - Coh. EXP-1 (EGFR-WT NSCLC) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with advanced or metastatic, EGFR-WT expressing NSCLC whose disease has progressed after having received ≥1 prior lines of therapy for advanced disease. Patients must have received at least a platinum-based doublet in combination with an anti--programmed cell death protein 1 (PD1)/programmed death-ligand 1 (PD-L1) antibody or must have received an anti-PD1/PD-L1 antibody prior to or after a platinum-based doublet. Patients with a known actionable driver mutation (other than EGFR mutation) must have received an approved targeted treatment for the respective mutation. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the standard of care (SOC) is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
| BG003 | Phase 2 - Coh. EXP-2 (Gastric or GEJ Adenocarcinoma) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with locally advanced, unresectable, or metastatic gastric or GEJ adenocarcinoma refractory to or, intolerant of, standard therapy. Patients must have received ≥1 prior chemotherapy regimen including a platinum and fluoropyrimidine doublet. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
| BG004 | Phase 2 - Coh. EXP-3 (Hepatocellular,Hepatobiliary,Pancreatic) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with advanced or metastatic hepatocellular carcinoma (other than fibrolamellar and sarcomatoid subtype; Barcelona Clinic Liver Cancer Stage C disease or Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy), hepatobiliary-, or pancreatic adenocarcinoma. Patients must have been treated with at least 1 previous line of an approved, SOC therapy for the respective disease type or, in the opinion of the Investigator, available SOC is not appropriate. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
| BG005 | Phase 2 - Coh. EXP-4 (EGFR Kinase Domain Mutation NSCLC) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with advanced or metastatic NSCLC harboring a targetable EGFR kinase domain mutation and whose disease has progressed on or after having received ≥1 prior lines of therapy for advanced disease including ≥1 prior tyrosine kinase inhibitor (TKI) approved for EGFR mutated NSCLC, such as gefitinib, erlotinib, afatinib, dacomitinib or osimertinib. Patients who were treated with a 1st or 2nd generation TKI in 1st line and developed a documented T790M mutation must have received a TKI targeting this mutation such as osimertinib or lazertinib to be eligible. Patients must have documentation of EGFR mutated NSCLC as assessed by an approved test using genomic sequencing of tumor or circulating free tumor DNA. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Phase 1: Incidence of Dose Limiting Toxicities (DLTs) During Cycle 1 | The number of patients with dose limiting toxicities (DLTs) in the first cycle, as assessed by the National Cancer Institute Common Technology Criteria for Adverse Events (CTCAE) v5.0 | Safety Analysis Set (SAS): All patients who received at least any amount of AFM24 or atezolizumab | Posted | Count of Participants | Participants | During cycle 1 (each cycle has 28 days) |
|
|
| |||||||||||||||||||||||||||||
| Primary | Phase 2a: Overall Response Rate (Complete Response [CR] or Partial Response [PR]) | Tumor assessment by RECIST v1.1 by investigator. Best overall response was used to define the Overall Response Rate (CR or PR). Best overall response is CR or PR if a CR or PR assessed at least 42 days after Cycle 1 Day 1 was confirmed by subsequent tumor assessment at least 4 weeks later. | Full Analysis Set (FAS): All patients who completed the Safety Lead-in phase and received any amount of any component of the combination treatments AFM24 and atezolizumab | Posted | Count of Participants | Participants | Tumor assessments were conducted during last week of cycle 2, 4, 6, 8, 10, 12 and every 3 cycles thereafter (each cycle has 28 days), up to approximately 97 weeks. |
| |||||||||||||||||||||||||||||||
| Secondary | Incidence of Patients With TEAEs | Number of patients with treatment-emergent adverse events (TEAEs) non-serious or serious | Safety Analysis Set (SAS): All patients who received at least any amount of AFM24 or atezolizumab | Posted | Count of Participants | Participants | From first drug administration up to 30 (non-serious TEAEs) or 56 (serious TEAEs) days after last dose AFM24, until start of a subsequent anticancer treatment, or data cut-off date, whichever is sooner. Up to approx. 35 (phase 1) and 105 weeks (phase 2a). |
| |||||||||||||||||||||||||||||||
| Secondary | Incidence of Patients With SAEs | Number of patients with treatment-emergent serious adverse events (serious TEAEs) | Safety Analysis Set (SAS): All patients who received at least any amount of AFM24 or atezolizumab | Posted | Count of Participants | Participants | From first drug administration up to 56 days after the last dose of AFM24, until the start of a subsequent anticancer treatment, or data cut-off date, whichever is sooner. Up to approximately 35 (phase 1) and 105 weeks (phase 2a). |
| |||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK) of AFM24 | Maximum plasma concentration (Cmax) on Cycle 1 Day 22 | All subjects who received at least one adequately documented dose of study drug and had sufficient PK measurements at Cycle 1 Day 22 analysed in central lab. | Posted | Mean | Standard Deviation | ng/mL | During cycle 1 (each cycle has 28 days) |
| ||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK) of AFM24 | Minimum plasma concentration (Cmin) Corresponding to Ctrough levels at the end of the dosing interval at Cycle 1 Day 22 | All subjects who received at least one adequately documented dose of study drug and had sufficient PK measurements at Cycle 1 Day 22 analysed in central lab. | Posted | Mean | Standard Deviation | ng/mL | During cycle 1 (each cycle has 28 days) |
| ||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK) of AFM24 | Area under the concentration-time curve over the dose interval (AUCtau) on Cycle 1 Day 22 | All subjects who received at least one adequately documented dose of study drug and had sufficient PK measurements at Cycle 1 Day 22 analysed in central lab. | Posted | Mean | Standard Deviation | hours*microgram /milliLiter | During cycle 1 (each cycle has 28 days) |
| ||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK) of AFM24 | Time to Cmax (Tmax) on Cycle 1 Day 22 | All subjects who received at least one adequately documented dose of study drug and had sufficient PK measurements at Cycle 1 Day 22 analysed in central lab. | Posted | Mean | Standard Deviation | h | During cycle 1 (each cycle has 28 days) |
| ||||||||||||||||||||||||||||||
| Secondary | Frequency of Patients Developing Anti-drug Antibodies (ADAs) Against AFM24 | Measurement of ADAs before and during treatment with AFM24 in combination with atezolizumab Patients with at least one ADA-positive result at baseline or post-baseline counted as developing anti-drug antibodies (ADAs) against AFM24 | Safety Analysis Set (SAS): All patients who received at least any amount of AFM24 or atezolizumab | Posted | Count of Participants | Participants | Ph 1 within 2h prior to: each drug intake (Cycle 1), 1st + 3rd drug intake (Cycle 2 onwards) and at EOT, up to 27 weeks. Ph 2a within 2h prior to: 1st drug intake (Cycle 1 and Cycle 3 onwards), 1st + 3rd drug intake (Cycle 2) and at EOT, up to 97 weeks. |
| |||||||||||||||||||||||||||||||
| Secondary | Phase 1: Overall Response Rate (Complete Response [CR] or Partial Response [PR]) | Tumor assessment by RECIST v1.1 by investigator. Best overall response was used to define the Overall Response Rate (CR or PR). Best overall response is CR or PR if a CR or PR assessed at least 42 days after Cycle 1 Day 1 was confirmed by subsequent tumor assessment at least 4 weeks later. | Full Analysis Set (FAS): All patients who completed the Safety Lead-in phase and received any amount of any component of the combination treatments AFM24 and atezolizumab | Posted | Count of Participants | Participants | Tumor assessments were conducted during last week of cycle 2, 4, 6, 8, 10, 12 and every 3 cycles thereafter (each cycle has 28 days), up to approximately 27 weeks. |
| |||||||||||||||||||||||||||||||
| Secondary | Phase 2a: Progression-free Survival | Progression-Free Survival (PFS) was defined as (date of first progression - date of first study drug injection)/30.4375. Patients without progression or death were censored. Tumor assessment by RECIST v1.1 by investigator. | Full Analysis Set (FAS): All patients who completed the Safety Lead-in phase and received any amount of any component of the combination treatments AFM24 and atezolizumab | Posted | Median | 95% Confidence Interval | Months | From the first treatment received until the first progression disease assessed by investigator or death. |
| ||||||||||||||||||||||||||||||
| Secondary | Phase 2a: Duration of Response | Duration of Response (DOR) was defined as (date of first progression or death - date of first response (unconfirmed))/30.4375. Patients without response were excluded from the analysis. Patients without progression or death were censored. Tumor assessment by RECIST v1.1 by investigator. | All patients from Full Analysis Set (FAS) (=completed the Safety Lead-in phase and received any amount of any component of the combination treatments AFM24 and atezolizumab) who had a response by RECIST v1.1 by investigator assessment. | Posted | Median | 95% Confidence Interval | Months | From the date of first response (unconfirmed) until progression disease assessed by investigator or death. |
| ||||||||||||||||||||||||||||||
| Secondary | Phase 2a: Clinical Benefit Rate (CR or PR [Any Duration] or Stable Disease Equal or > 24 Weeks) | Tumor assessment by RECIST v1.1 by investigator. Best overall response was used to define the Clinical benefit rate (CR or PR or SD ≥24 weeks). Best overall response is CR or PR if a CR or PR assessed at least 42 days after Cycle 1 Day 1 was confirmed by subsequent tumor assessment at least 4 weeks later. Best overall response is SD if SD or unconfirmed CR or unconfirmed PR at least 42 days after C1D1. Best overall response SD counts for Clinical benefit rate if SD ongoing for at least 24 weeks. | Full Analysis Set (FAS): All patients who completed the Safety Lead-in phase and received any amount of any component of the combination treatments AFM24 and atezolizumab | Posted | Count of Participants | Participants | Tumor assessments were conducted during last week of cycle 2, 4, 6, 8, 10, 12 and every 3 cycles thereafter (each cycle has 28 days), up to approximately 97 weeks. |
| |||||||||||||||||||||||||||||||
| Secondary | Phase 2a: Disease Control Rate (DCR) (Complete Response [CR] or Partial Response [PR] or Stable Disease [SD]) | Tumor assessment by RECIST v1.1 by investigator. Best overall response was used to define the Disease Control Rate (CR or PR or SD). Best overall response is CR or PR if a CR or PR assessed at least 42 days after Cycle 1 Day 1 was confirmed by subsequent tumor assessment at least 4 weeks later. Best overall response is SD if SD or unconfirmed CR or unconfirmed PR at least 42 days after C1D1. | Full Analysis Set (FAS): All patients who completed the Safety Lead-in phase and received any amount of any component of the combination treatments AFM24 and atezolizumab | Posted | Count of Participants | Participants | Tumor assessments were conducted during last week of cycle 2, 4, 6, 8, 10, 12 and every 3 cycles thereafter (each cycle has 28 days), up to approximately 97 weeks. |
|
From first drug administration up to 30 (TEAEs) or 56 (SAEs) days after the last dose of AFM24, until the start of a subsequent anticancer treatment, or data cut-off date, whichever is sooner. Up to approximately 35 (phase 1) and 105 weeks (phase 2a).
Safety Analysis Set (SAS): All patients who received at least any amount of AFM24 or atezolizumab.
Reported in the tables below are the TEAEs (treatment-emergent Adverse Events).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1 - Cohort 1 - AFM24 160 mg + Atezolizumab 840 mg | Patients aged 18 years or older with documented histologically or cytologically confirmed select advanced or metastatic epidermal growth factor receptor (EGFR)-positive cancers. The patients received AFM24 160 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. | 3 | 4 | 2 | 4 | 4 | 4 |
| EG001 | Phase 1 - Cohort 2 - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with documented histologically or cytologically confirmed select advanced or metastatic epidermal growth factor receptor (EGFR)-positive cancers. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. | 5 | 6 | 3 | 6 | 6 | 6 |
| EG002 | Phase 2 - Coh. EXP-1 (EGFR-WT NSCLC) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with advanced or metastatic, EGFR-WT expressing NSCLC whose disease has progressed after having received ≥1 prior lines of therapy for advanced disease. Patients must have received at least a platinum-based doublet in combination with an anti--programmed cell death protein 1 (PD1)/programmed death-ligand 1 (PD-L1) antibody or must have received an anti-PD1/PD-L1 antibody prior to or after a platinum-based doublet. Patients with a known actionable driver mutation (other than EGFR mutation) must have received an approved targeted treatment for the respective mutation. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the standard of care (SOC) is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. | 21 | 49 | 30 | 49 | 48 | 49 |
| EG003 | Phase 2 - Coh. EXP-2 (Gastric or GEJ Adenocarcinoma) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with locally advanced, unresectable, or metastatic gastric or GEJ adenocarcinoma refractory to or, intolerant of, standard therapy. Patients must have received ≥1 prior chemotherapy regimen including a platinum and fluoropyrimidine doublet. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. | 9 | 12 | 6 | 12 | 11 | 12 |
| EG004 | Phase 2 - Coh. EXP-3 (Hepatocellular,Hepatobiliary,Pancreatic) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with advanced or metastatic hepatocellular carcinoma (other than fibrolamellar and sarcomatoid subtype; Barcelona Clinic Liver Cancer Stage C disease or Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy), hepatobiliary-, or pancreatic adenocarcinoma. Patients must have been treated with at least 1 previous line of an approved, SOC therapy for the respective disease type or, in the opinion of the Investigator, available SOC is not appropriate. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. | 9 | 11 | 7 | 11 | 11 | 11 |
| EG005 | Phase 2 - Coh. EXP-4 (EGFR Kinase Domain Mutation NSCLC) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with advanced or metastatic NSCLC harboring a targetable EGFR kinase domain mutation and whose disease has progressed on or after having received ≥1 prior lines of therapy for advanced disease including ≥1 prior tyrosine kinase inhibitor (TKI) approved for EGFR mutated NSCLC, such as gefitinib, erlotinib, afatinib, dacomitinib or osimertinib. Patients who were treated with a 1st or 2nd generation TKI in 1st line and developed a documented T790M mutation must have received a TKI targeting this mutation such as osimertinib or lazertinib to be eligible. Patients must have documentation of EGFR mutated NSCLC as assessed by an approved test using genomic sequencing of tumor or circulating free tumor DNA. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. | 9 | 30 | 15 | 30 | 29 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| COVID-19 | Infections and infestations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Biliary sepsis | Infections and infestations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| COVID-19 pneumonia | Infections and infestations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Endocarditis | Infections and infestations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Escherichia bacteraemia | Infections and infestations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Escherichia sepsis | Infections and infestations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Lung abscess | Infections and infestations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Peritonitis | Infections and infestations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Sepsis | Infections and infestations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Urinary tract infection | Infections and infestations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Sputum increased | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Fall | Injury, poisoning and procedural complications | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Dysphagia | Gastrointestinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Constipation | Gastrointestinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Anaemia of malignant disease | Blood and lymphatic system disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Atrial fibrillation | Cardiac disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Cardiac tamponade | Cardiac disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Coronary artery disease | Cardiac disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Myocardial infarction | Cardiac disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Fatigue | General disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Hyperthermia malignant | General disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Multiple organ dysfunction syndrome | General disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Pain | General disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Seizure | Nervous system disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Alanine aminotransferase increased | Investigations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Aspartate aminotransferase increased | Investigations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Blood bilirubin increased | Investigations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Cytokine release syndrome | Immune system disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Hypophagia | Metabolism and nutrition disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Pelvic venous thrombosis | Vascular disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Superior vena cava syndrome | Vascular disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Vaginal prolapse | Reproductive system and breast disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Medication error | Injury, poisoning and procedural complications | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Fall | Injury, poisoning and procedural complications | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Radiation mucositis | Injury, poisoning and procedural complications | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Asthenia | General disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Fatigue | General disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Pyrexia | General disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Chest pain | General disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Chills | General disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Oedema peripheral | General disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Catheter site pain | General disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Exercise tolerance decreased | General disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Malaise | General disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Oedema | General disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Pain | General disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Soft tissue inflammation | General disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Swelling | General disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Constipation | Gastrointestinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Nausea | Gastrointestinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Vomiting | Gastrointestinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Ascites | Gastrointestinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Dry mouth | Gastrointestinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Dysphagia | Gastrointestinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Gingival pain | Gastrointestinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Stomatitis | Gastrointestinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Tongue ulceration | Gastrointestinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Toothache | Gastrointestinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Alanine aminotransferase increased | Investigations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Aspartate aminotransferase increased | Investigations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Neutrophil count decreased | Investigations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Amylase increased | Investigations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Lipase increased | Investigations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Weight decreased | Investigations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Hepatic enzyme increased | Investigations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Blood creatinine increased | Investigations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Bilirubin conjugated increased | Investigations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Blood bilirubin increased | Investigations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| C-reactive protein increased | Investigations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Heart rate decreased | Investigations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Lymphocyte count decreased | Investigations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Platelet count decreased | Investigations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Waist circumference increased | Investigations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Weight increased | Investigations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| White blood cells urine positive | Investigations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Herpes zoster | Infections and infestations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Paronychia | Infections and infestations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Rash pustular | Infections and infestations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| COVID-19 | Infections and infestations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Nasopharyngitis | Infections and infestations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Pneumonia | Infections and infestations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Urinary tract infection | Infections and infestations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Viral infection | Infections and infestations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Bacteraemia | Infections and infestations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Bronchitis | Infections and infestations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Candida infection | Infections and infestations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Influenza | Infections and infestations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Otitis media | Infections and infestations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Respiratory tract infection | Infections and infestations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Sinusitis | Infections and infestations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Skin infection | Infections and infestations | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Catarrh | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Increased tendency to bruise | Blood and lymphatic system disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Butterfly rash | Skin and subcutaneous tissue disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Macule | Skin and subcutaneous tissue disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Perioral dermatitis | Skin and subcutaneous tissue disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Skin maceration | Skin and subcutaneous tissue disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Headache | Nervous system disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Paraesthesia | Nervous system disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Dizziness | Nervous system disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Taste disorder | Nervous system disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Aphasia | Nervous system disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Restless legs syndrome | Nervous system disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Seizure | Nervous system disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Syncope | Nervous system disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Vocal cord paralysis | Nervous system disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Hypertension | Vascular disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Haematoma | Vascular disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Hypotension | Vascular disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Peripheral artery thrombosis | Vascular disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Peripheral venous disease | Vascular disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Superior vena cava syndrome | Vascular disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Vena cava thrombosis | Vascular disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Insomnia | Psychiatric disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Anxiety | Psychiatric disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Atrial fibrillation | Cardiac disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Angina unstable | Cardiac disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Adrenal insufficiency | Endocrine disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Hyperthyroidism | Endocrine disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Hypothyroidism | Endocrine disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Hepatitis | Hepatobiliary disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Jaundice | Hepatobiliary disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Haematuria | Renal and urinary disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Dry eye | Eye disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Ocular hyperaemia | Eye disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Ear pain | Ear and labyrinth disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Contrast media allergy | Immune system disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA version 27.0 | Systematic Assessment | TEAE |
|
The study was terminated early (early termination submitted to FDA on 12 June 2025). The decision to terminate early was solely based on the company's financial situation and not influenced by safety or efficacy data. The primary completion date, i.e when the criteria for the final analysis according to the protocol are met is: 06 March, 2025. The data snapshot used for the reported results is 07 April, 2025 (not fully cleaned). SDVs performed: 99.7% for Phase 1, 97.1% for Phase 2.
The sponsor has the right to review communications for 90 days prior to public release (whereby the sponsor may ask to consider modifications to ensure necessary protection of sponsor's IP). Any publication shall be not made before the first multi-centre publication if the study is a part of a multi-centred clinical trial. Also, if a publication concerns the analyses of data from a multi-centred clinical trial, the communication shall make reference to the relevant multi-centre publication
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Affimed GmbH | +49 621 56003-0 | trials@affimed.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 22, 2024 | Jul 18, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|
| Poland |
|
| United Kingdom |
|
| Spain |
|
| OG001 | Phase 2 - Coh. EXP-2 (Gastric or GEJ Adenocarcinoma) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with locally advanced, unresectable, or metastatic gastric or GEJ adenocarcinoma refractory to or, intolerant of, standard therapy. Patients must have received ≥1 prior chemotherapy regimen including a platinum and fluoropyrimidine doublet. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
| OG002 | Phase 2 - Coh. EXP-3 (Hepatocellular,Hepatobiliary,Pancreatic) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with advanced or metastatic hepatocellular carcinoma (other than fibrolamellar and sarcomatoid subtype; Barcelona Clinic Liver Cancer Stage C disease or Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy), hepatobiliary-, or pancreatic adenocarcinoma. Patients must have been treated with at least 1 previous line of an approved, SOC therapy for the respective disease type or, in the opinion of the Investigator, available SOC is not appropriate. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
| OG003 | Phase 2 - Coh. EXP-4 (EGFR Kinase Domain Mutation NSCLC) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with advanced or metastatic NSCLC harboring a targetable EGFR kinase domain mutation and whose disease has progressed on or after having received ≥1 prior lines of therapy for advanced disease including ≥1 prior tyrosine kinase inhibitor (TKI) approved for EGFR mutated NSCLC, such as gefitinib, erlotinib, afatinib, dacomitinib or osimertinib. Patients who were treated with a 1st or 2nd generation TKI in 1st line and developed a documented T790M mutation must have received a TKI targeting this mutation such as osimertinib or lazertinib to be eligible. Patients must have documentation of EGFR mutated NSCLC as assessed by an approved test using genomic sequencing of tumor or circulating free tumor DNA. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
|
|
| OG002 | Phase 2 - Coh. EXP-1 (EGFR-WT NSCLC) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with advanced or metastatic, EGFR-WT expressing NSCLC whose disease has progressed after having received ≥1 prior lines of therapy for advanced disease. Patients must have received at least a platinum-based doublet in combination with an anti--programmed cell death protein 1 (PD1)/programmed death-ligand 1 (PD-L1) antibody or must have received an anti-PD1/PD-L1 antibody prior to or after a platinum-based doublet. Patients with a known actionable driver mutation (other than EGFR mutation) must have received an approved targeted treatment for the respective mutation. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the standard of care (SOC) is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
| OG003 | Phase 2 - Coh. EXP-2 (Gastric or GEJ Adenocarcinoma) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with locally advanced, unresectable, or metastatic gastric or GEJ adenocarcinoma refractory to or, intolerant of, standard therapy. Patients must have received ≥1 prior chemotherapy regimen including a platinum and fluoropyrimidine doublet. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
| OG004 | Phase 2 - Coh. EXP-3 (Hepatocellular,Hepatobiliary,Pancreatic) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with advanced or metastatic hepatocellular carcinoma (other than fibrolamellar and sarcomatoid subtype; Barcelona Clinic Liver Cancer Stage C disease or Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy), hepatobiliary-, or pancreatic adenocarcinoma. Patients must have been treated with at least 1 previous line of an approved, SOC therapy for the respective disease type or, in the opinion of the Investigator, available SOC is not appropriate. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
| OG005 | Phase 2 - Coh. EXP-4 (EGFR Kinase Domain Mutation NSCLC) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with advanced or metastatic NSCLC harboring a targetable EGFR kinase domain mutation and whose disease has progressed on or after having received ≥1 prior lines of therapy for advanced disease including ≥1 prior tyrosine kinase inhibitor (TKI) approved for EGFR mutated NSCLC, such as gefitinib, erlotinib, afatinib, dacomitinib or osimertinib. Patients who were treated with a 1st or 2nd generation TKI in 1st line and developed a documented T790M mutation must have received a TKI targeting this mutation such as osimertinib or lazertinib to be eligible. Patients must have documentation of EGFR mutated NSCLC as assessed by an approved test using genomic sequencing of tumor or circulating free tumor DNA. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
|
|
| OG002 | Phase 2 - Coh. EXP-1 (EGFR-WT NSCLC) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with advanced or metastatic, EGFR-WT expressing NSCLC whose disease has progressed after having received ≥1 prior lines of therapy for advanced disease. Patients must have received at least a platinum-based doublet in combination with an anti--programmed cell death protein 1 (PD1)/programmed death-ligand 1 (PD-L1) antibody or must have received an anti-PD1/PD-L1 antibody prior to or after a platinum-based doublet. Patients with a known actionable driver mutation (other than EGFR mutation) must have received an approved targeted treatment for the respective mutation. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the standard of care (SOC) is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
| OG003 | Phase 2 - Coh. EXP-2 (Gastric or GEJ Adenocarcinoma) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with locally advanced, unresectable, or metastatic gastric or GEJ adenocarcinoma refractory to or, intolerant of, standard therapy. Patients must have received ≥1 prior chemotherapy regimen including a platinum and fluoropyrimidine doublet. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
| OG004 | Phase 2 - Coh. EXP-3 (Hepatocellular,Hepatobiliary,Pancreatic) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with advanced or metastatic hepatocellular carcinoma (other than fibrolamellar and sarcomatoid subtype; Barcelona Clinic Liver Cancer Stage C disease or Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy), hepatobiliary-, or pancreatic adenocarcinoma. Patients must have been treated with at least 1 previous line of an approved, SOC therapy for the respective disease type or, in the opinion of the Investigator, available SOC is not appropriate. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
| OG005 | Phase 2 - Coh. EXP-4 (EGFR Kinase Domain Mutation NSCLC) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with advanced or metastatic NSCLC harboring a targetable EGFR kinase domain mutation and whose disease has progressed on or after having received ≥1 prior lines of therapy for advanced disease including ≥1 prior tyrosine kinase inhibitor (TKI) approved for EGFR mutated NSCLC, such as gefitinib, erlotinib, afatinib, dacomitinib or osimertinib. Patients who were treated with a 1st or 2nd generation TKI in 1st line and developed a documented T790M mutation must have received a TKI targeting this mutation such as osimertinib or lazertinib to be eligible. Patients must have documentation of EGFR mutated NSCLC as assessed by an approved test using genomic sequencing of tumor or circulating free tumor DNA. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
|
|
Patients aged 18 years or older with advanced or metastatic, EGFR-WT expressing NSCLC whose disease has progressed after having received ≥1 prior lines of therapy for advanced disease. Patients must have received at least a platinum-based doublet in combination with an anti--programmed cell death protein 1 (PD1)/programmed death-ligand 1 (PD-L1) antibody or must have received an anti-PD1/PD-L1 antibody prior to or after a platinum-based doublet. Patients with a known actionable driver mutation (other than EGFR mutation) must have received an approved targeted treatment for the respective mutation. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the standard of care (SOC) is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
| OG003 | Phase 2 - Coh. EXP-2 (Gastric or GEJ Adenocarcinoma) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with locally advanced, unresectable, or metastatic gastric or GEJ adenocarcinoma refractory to or, intolerant of, standard therapy. Patients must have received ≥1 prior chemotherapy regimen including a platinum and fluoropyrimidine doublet. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
| OG004 | Phase 2 - Coh. EXP-3 (Hepatocellular,Hepatobiliary,Pancreatic) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with advanced or metastatic hepatocellular carcinoma (other than fibrolamellar and sarcomatoid subtype; Barcelona Clinic Liver Cancer Stage C disease or Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy), hepatobiliary-, or pancreatic adenocarcinoma. Patients must have been treated with at least 1 previous line of an approved, SOC therapy for the respective disease type or, in the opinion of the Investigator, available SOC is not appropriate. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
| OG005 | Phase 2 - Coh. EXP-4 (EGFR Kinase Domain Mutation NSCLC) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with advanced or metastatic NSCLC harboring a targetable EGFR kinase domain mutation and whose disease has progressed on or after having received ≥1 prior lines of therapy for advanced disease including ≥1 prior tyrosine kinase inhibitor (TKI) approved for EGFR mutated NSCLC, such as gefitinib, erlotinib, afatinib, dacomitinib or osimertinib. Patients who were treated with a 1st or 2nd generation TKI in 1st line and developed a documented T790M mutation must have received a TKI targeting this mutation such as osimertinib or lazertinib to be eligible. Patients must have documentation of EGFR mutated NSCLC as assessed by an approved test using genomic sequencing of tumor or circulating free tumor DNA. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
|
|
| Phase 2 - Coh. EXP-1 (EGFR-WT NSCLC) - AFM24 480 mg + Atezolizumab 840 mg |
Patients aged 18 years or older with advanced or metastatic, EGFR-WT expressing NSCLC whose disease has progressed after having received ≥1 prior lines of therapy for advanced disease. Patients must have received at least a platinum-based doublet in combination with an anti--programmed cell death protein 1 (PD1)/programmed death-ligand 1 (PD-L1) antibody or must have received an anti-PD1/PD-L1 antibody prior to or after a platinum-based doublet. Patients with a known actionable driver mutation (other than EGFR mutation) must have received an approved targeted treatment for the respective mutation. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the standard of care (SOC) is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
| OG003 | Phase 2 - Coh. EXP-2 (Gastric or GEJ Adenocarcinoma) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with locally advanced, unresectable, or metastatic gastric or GEJ adenocarcinoma refractory to or, intolerant of, standard therapy. Patients must have received ≥1 prior chemotherapy regimen including a platinum and fluoropyrimidine doublet. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
| OG004 | Phase 2 - Coh. EXP-3 (Hepatocellular,Hepatobiliary,Pancreatic) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with advanced or metastatic hepatocellular carcinoma (other than fibrolamellar and sarcomatoid subtype; Barcelona Clinic Liver Cancer Stage C disease or Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy), hepatobiliary-, or pancreatic adenocarcinoma. Patients must have been treated with at least 1 previous line of an approved, SOC therapy for the respective disease type or, in the opinion of the Investigator, available SOC is not appropriate. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
| OG005 | Phase 2 - Coh. EXP-4 (EGFR Kinase Domain Mutation NSCLC) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with advanced or metastatic NSCLC harboring a targetable EGFR kinase domain mutation and whose disease has progressed on or after having received ≥1 prior lines of therapy for advanced disease including ≥1 prior tyrosine kinase inhibitor (TKI) approved for EGFR mutated NSCLC, such as gefitinib, erlotinib, afatinib, dacomitinib or osimertinib. Patients who were treated with a 1st or 2nd generation TKI in 1st line and developed a documented T790M mutation must have received a TKI targeting this mutation such as osimertinib or lazertinib to be eligible. Patients must have documentation of EGFR mutated NSCLC as assessed by an approved test using genomic sequencing of tumor or circulating free tumor DNA. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
|
|
| Phase 2 - Coh. EXP-1 (EGFR-WT NSCLC) - AFM24 480 mg + Atezolizumab 840 mg |
Patients aged 18 years or older with advanced or metastatic, EGFR-WT expressing NSCLC whose disease has progressed after having received ≥1 prior lines of therapy for advanced disease. Patients must have received at least a platinum-based doublet in combination with an anti--programmed cell death protein 1 (PD1)/programmed death-ligand 1 (PD-L1) antibody or must have received an anti-PD1/PD-L1 antibody prior to or after a platinum-based doublet. Patients with a known actionable driver mutation (other than EGFR mutation) must have received an approved targeted treatment for the respective mutation. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the standard of care (SOC) is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
| OG003 | Phase 2 - Coh. EXP-2 (Gastric or GEJ Adenocarcinoma) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with locally advanced, unresectable, or metastatic gastric or GEJ adenocarcinoma refractory to or, intolerant of, standard therapy. Patients must have received ≥1 prior chemotherapy regimen including a platinum and fluoropyrimidine doublet. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
| OG004 | Phase 2 - Coh. EXP-3 (Hepatocellular,Hepatobiliary,Pancreatic) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with advanced or metastatic hepatocellular carcinoma (other than fibrolamellar and sarcomatoid subtype; Barcelona Clinic Liver Cancer Stage C disease or Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy), hepatobiliary-, or pancreatic adenocarcinoma. Patients must have been treated with at least 1 previous line of an approved, SOC therapy for the respective disease type or, in the opinion of the Investigator, available SOC is not appropriate. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
| OG005 | Phase 2 - Coh. EXP-4 (EGFR Kinase Domain Mutation NSCLC) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with advanced or metastatic NSCLC harboring a targetable EGFR kinase domain mutation and whose disease has progressed on or after having received ≥1 prior lines of therapy for advanced disease including ≥1 prior tyrosine kinase inhibitor (TKI) approved for EGFR mutated NSCLC, such as gefitinib, erlotinib, afatinib, dacomitinib or osimertinib. Patients who were treated with a 1st or 2nd generation TKI in 1st line and developed a documented T790M mutation must have received a TKI targeting this mutation such as osimertinib or lazertinib to be eligible. Patients must have documentation of EGFR mutated NSCLC as assessed by an approved test using genomic sequencing of tumor or circulating free tumor DNA. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
|
|
Patients aged 18 years or older with advanced or metastatic, EGFR-WT expressing NSCLC whose disease has progressed after having received ≥1 prior lines of therapy for advanced disease. Patients must have received at least a platinum-based doublet in combination with an anti--programmed cell death protein 1 (PD1)/programmed death-ligand 1 (PD-L1) antibody or must have received an anti-PD1/PD-L1 antibody prior to or after a platinum-based doublet. Patients with a known actionable driver mutation (other than EGFR mutation) must have received an approved targeted treatment for the respective mutation. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the standard of care (SOC) is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
| OG003 | Phase 2 - Coh. EXP-2 (Gastric or GEJ Adenocarcinoma) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with locally advanced, unresectable, or metastatic gastric or GEJ adenocarcinoma refractory to or, intolerant of, standard therapy. Patients must have received ≥1 prior chemotherapy regimen including a platinum and fluoropyrimidine doublet. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
| OG004 | Phase 2 - Coh. EXP-3 (Hepatocellular,Hepatobiliary,Pancreatic) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with advanced or metastatic hepatocellular carcinoma (other than fibrolamellar and sarcomatoid subtype; Barcelona Clinic Liver Cancer Stage C disease or Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy), hepatobiliary-, or pancreatic adenocarcinoma. Patients must have been treated with at least 1 previous line of an approved, SOC therapy for the respective disease type or, in the opinion of the Investigator, available SOC is not appropriate. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
| OG005 | Phase 2 - Coh. EXP-4 (EGFR Kinase Domain Mutation NSCLC) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with advanced or metastatic NSCLC harboring a targetable EGFR kinase domain mutation and whose disease has progressed on or after having received ≥1 prior lines of therapy for advanced disease including ≥1 prior tyrosine kinase inhibitor (TKI) approved for EGFR mutated NSCLC, such as gefitinib, erlotinib, afatinib, dacomitinib or osimertinib. Patients who were treated with a 1st or 2nd generation TKI in 1st line and developed a documented T790M mutation must have received a TKI targeting this mutation such as osimertinib or lazertinib to be eligible. Patients must have documentation of EGFR mutated NSCLC as assessed by an approved test using genomic sequencing of tumor or circulating free tumor DNA. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
|
|
| OG002 | Phase 2 - Coh. EXP-1 (EGFR-WT NSCLC) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with advanced or metastatic, EGFR-WT expressing NSCLC whose disease has progressed after having received ≥1 prior lines of therapy for advanced disease. Patients must have received at least a platinum-based doublet in combination with an anti--programmed cell death protein 1 (PD1)/programmed death-ligand 1 (PD-L1) antibody or must have received an anti-PD1/PD-L1 antibody prior to or after a platinum-based doublet. Patients with a known actionable driver mutation (other than EGFR mutation) must have received an approved targeted treatment for the respective mutation. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the standard of care (SOC) is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
| OG003 | Phase 2 - Coh. EXP-2 (Gastric or GEJ Adenocarcinoma) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with locally advanced, unresectable, or metastatic gastric or GEJ adenocarcinoma refractory to or, intolerant of, standard therapy. Patients must have received ≥1 prior chemotherapy regimen including a platinum and fluoropyrimidine doublet. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
| OG004 | Phase 2 - Coh. EXP-3 (Hepatocellular,Hepatobiliary,Pancreatic) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with advanced or metastatic hepatocellular carcinoma (other than fibrolamellar and sarcomatoid subtype; Barcelona Clinic Liver Cancer Stage C disease or Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy), hepatobiliary-, or pancreatic adenocarcinoma. Patients must have been treated with at least 1 previous line of an approved, SOC therapy for the respective disease type or, in the opinion of the Investigator, available SOC is not appropriate. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
| OG005 | Phase 2 - Coh. EXP-4 (EGFR Kinase Domain Mutation NSCLC) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with advanced or metastatic NSCLC harboring a targetable EGFR kinase domain mutation and whose disease has progressed on or after having received ≥1 prior lines of therapy for advanced disease including ≥1 prior tyrosine kinase inhibitor (TKI) approved for EGFR mutated NSCLC, such as gefitinib, erlotinib, afatinib, dacomitinib or osimertinib. Patients who were treated with a 1st or 2nd generation TKI in 1st line and developed a documented T790M mutation must have received a TKI targeting this mutation such as osimertinib or lazertinib to be eligible. Patients must have documentation of EGFR mutated NSCLC as assessed by an approved test using genomic sequencing of tumor or circulating free tumor DNA. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
|
|
|
|
| OG001 | Phase 2 - Coh. EXP-2 (Gastric or GEJ Adenocarcinoma) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with locally advanced, unresectable, or metastatic gastric or GEJ adenocarcinoma refractory to or, intolerant of, standard therapy. Patients must have received ≥1 prior chemotherapy regimen including a platinum and fluoropyrimidine doublet. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
| OG002 | Phase 2 - Coh. EXP-3 (Hepatocellular,Hepatobiliary,Pancreatic) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with advanced or metastatic hepatocellular carcinoma (other than fibrolamellar and sarcomatoid subtype; Barcelona Clinic Liver Cancer Stage C disease or Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy), hepatobiliary-, or pancreatic adenocarcinoma. Patients must have been treated with at least 1 previous line of an approved, SOC therapy for the respective disease type or, in the opinion of the Investigator, available SOC is not appropriate. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
| OG003 | Phase 2 - Coh. EXP-4 (EGFR Kinase Domain Mutation NSCLC) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with advanced or metastatic NSCLC harboring a targetable EGFR kinase domain mutation and whose disease has progressed on or after having received ≥1 prior lines of therapy for advanced disease including ≥1 prior tyrosine kinase inhibitor (TKI) approved for EGFR mutated NSCLC, such as gefitinib, erlotinib, afatinib, dacomitinib or osimertinib. Patients who were treated with a 1st or 2nd generation TKI in 1st line and developed a documented T790M mutation must have received a TKI targeting this mutation such as osimertinib or lazertinib to be eligible. Patients must have documentation of EGFR mutated NSCLC as assessed by an approved test using genomic sequencing of tumor or circulating free tumor DNA. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
|
|
| OG001 | Phase 2 - Coh. EXP-2 (Gastric or GEJ Adenocarcinoma) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with locally advanced, unresectable, or metastatic gastric or GEJ adenocarcinoma refractory to or, intolerant of, standard therapy. Patients must have received ≥1 prior chemotherapy regimen including a platinum and fluoropyrimidine doublet. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
| OG002 | Phase 2 - Coh. EXP-3 (Hepatocellular,Hepatobiliary,Pancreatic) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with advanced or metastatic hepatocellular carcinoma (other than fibrolamellar and sarcomatoid subtype; Barcelona Clinic Liver Cancer Stage C disease or Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy), hepatobiliary-, or pancreatic adenocarcinoma. Patients must have been treated with at least 1 previous line of an approved, SOC therapy for the respective disease type or, in the opinion of the Investigator, available SOC is not appropriate. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
| OG003 | Phase 2 - Coh. EXP-4 (EGFR Kinase Domain Mutation NSCLC) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with advanced or metastatic NSCLC harboring a targetable EGFR kinase domain mutation and whose disease has progressed on or after having received ≥1 prior lines of therapy for advanced disease including ≥1 prior tyrosine kinase inhibitor (TKI) approved for EGFR mutated NSCLC, such as gefitinib, erlotinib, afatinib, dacomitinib or osimertinib. Patients who were treated with a 1st or 2nd generation TKI in 1st line and developed a documented T790M mutation must have received a TKI targeting this mutation such as osimertinib or lazertinib to be eligible. Patients must have documentation of EGFR mutated NSCLC as assessed by an approved test using genomic sequencing of tumor or circulating free tumor DNA. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
|
|
| OG001 | Phase 2 - Coh. EXP-2 (Gastric or GEJ Adenocarcinoma) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with locally advanced, unresectable, or metastatic gastric or GEJ adenocarcinoma refractory to or, intolerant of, standard therapy. Patients must have received ≥1 prior chemotherapy regimen including a platinum and fluoropyrimidine doublet. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
| OG002 | Phase 2 - Coh. EXP-3 (Hepatocellular,Hepatobiliary,Pancreatic) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with advanced or metastatic hepatocellular carcinoma (other than fibrolamellar and sarcomatoid subtype; Barcelona Clinic Liver Cancer Stage C disease or Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy), hepatobiliary-, or pancreatic adenocarcinoma. Patients must have been treated with at least 1 previous line of an approved, SOC therapy for the respective disease type or, in the opinion of the Investigator, available SOC is not appropriate. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
| OG003 | Phase 2 - Coh. EXP-4 (EGFR Kinase Domain Mutation NSCLC) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with advanced or metastatic NSCLC harboring a targetable EGFR kinase domain mutation and whose disease has progressed on or after having received ≥1 prior lines of therapy for advanced disease including ≥1 prior tyrosine kinase inhibitor (TKI) approved for EGFR mutated NSCLC, such as gefitinib, erlotinib, afatinib, dacomitinib or osimertinib. Patients who were treated with a 1st or 2nd generation TKI in 1st line and developed a documented T790M mutation must have received a TKI targeting this mutation such as osimertinib or lazertinib to be eligible. Patients must have documentation of EGFR mutated NSCLC as assessed by an approved test using genomic sequencing of tumor or circulating free tumor DNA. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
|
|
| OG001 | Phase 2 - Coh. EXP-2 (Gastric or GEJ Adenocarcinoma) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with locally advanced, unresectable, or metastatic gastric or GEJ adenocarcinoma refractory to or, intolerant of, standard therapy. Patients must have received ≥1 prior chemotherapy regimen including a platinum and fluoropyrimidine doublet. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
| OG002 | Phase 2 - Coh. EXP-3 (Hepatocellular,Hepatobiliary,Pancreatic) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with advanced or metastatic hepatocellular carcinoma (other than fibrolamellar and sarcomatoid subtype; Barcelona Clinic Liver Cancer Stage C disease or Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy), hepatobiliary-, or pancreatic adenocarcinoma. Patients must have been treated with at least 1 previous line of an approved, SOC therapy for the respective disease type or, in the opinion of the Investigator, available SOC is not appropriate. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
| OG003 | Phase 2 - Coh. EXP-4 (EGFR Kinase Domain Mutation NSCLC) - AFM24 480 mg + Atezolizumab 840 mg | Patients aged 18 years or older with advanced or metastatic NSCLC harboring a targetable EGFR kinase domain mutation and whose disease has progressed on or after having received ≥1 prior lines of therapy for advanced disease including ≥1 prior tyrosine kinase inhibitor (TKI) approved for EGFR mutated NSCLC, such as gefitinib, erlotinib, afatinib, dacomitinib or osimertinib. Patients who were treated with a 1st or 2nd generation TKI in 1st line and developed a documented T790M mutation must have received a TKI targeting this mutation such as osimertinib or lazertinib to be eligible. Patients must have documentation of EGFR mutated NSCLC as assessed by an approved test using genomic sequencing of tumor or circulating free tumor DNA. The patients should also have received a second line of treatment if approved and available, or they may be enrolled in the study if in the opinion of the Investigator it is in the patient's best interest, or the SOC is not appropriate. The patients received AFM24 480 mg i.v. qw + atezolizumab 840 mg i.v. q2w in 28-day cycles. AFM24 on Day 1, Day 8, Day 15, and Day 22 (a dose could be given as split day dosing over two days) + atezolizumab on Day 1 and Day 15. |
|
|