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The comprehensive assessment of other studies indicated the lack of significant monotherapy activity, therefore, team decided to terminate the study.
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The purpose of this study was to evaluate the safety, and tolerability of ASP0739, when administered as a single agent and in combination with pembrolizumab.
This study also evaluated the clinical response and other measures of anticancer activity of ASP0739 when administered as a single agent and in combination with pembrolizumab based on central and local assessment.
The study comprised of 2 phases. Phase 1 (dose escalation) included participants with solid tumors known to express New York esophageal squamous cell carcinoma 1 (NY-ESO-1). Phase 2 (ASP0739 as single agent and in combination with pembrolizumab) included participants with relapsed/refractory Synovial Sarcoma (SS), myxoid/round cell liposarcoma (MRCL), and ovarian cancer who had not responded to Standard of Care (SOC) or were ineligible for standard therapy. Phase 2 single agent also included a cohort of participants with select solid tumors known to express NY-ESO-1 (melanoma, Non Small Cell Lung Cancer-adenocarcinoma [NSCLC], squamous cell and esophageal squamous cell carcinoma [ESCC]). Japanese participants were only enrolled into the monotherapy arm of the dose expansion cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation (Phase 1): ASP0739 1x10^7 cells/mL | Experimental | Participants with Relapsed/Refractory (R/R) solid tumors known to express New York esophageal squamous cell carcinoma 1 (NY-ESO-1) received intravenous (IV) infusion of ASP0739 (human embryonic kidney cell [HEK293] transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^7 cells/milliliters (mL) at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a partial response (PR) or stable disease (SD) (1 cycle= 28 days). . |
|
| Dose Escalation (Phase 1): ASP0739 1x10^8 cells/mL | Experimental | Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
|
| Dose Expansion (Phase 2): ASP0739 1x10^8 cells/mL | Experimental | Participants with synovial sarcoma (SS), myxoid/round cell liposarcoma (MRCL), ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, non-small cell lung cancer [NSCLC] adenocarcinoma and squamous cell and esophageal squamous cell carcinoma [ESCC]) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP0739 | Drug | Intravenous (IV) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs) | DLT was defined as any event occurring within 28 days of first dose on C1D1 and graded as:
| Cycle 1 Day 1 (C1D1) up to C1D28 |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) & Serious Adverse Events (SAEs) | An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An AE was considered "serious" if, it resulted in any of the following outcomes: results in death; is life-threatening; results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly, or birth defect; requires inpatient hospitalization; or leads to prolongation of hospitalization; other medically important events. A treatment-emergent adverse event (TEAE) was defined as an AE observed after the date of first dose until 30 days after the last dose. | From first dose up to 198 days |
| Number of Participants With ECOG Performance Status at C1D2 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (ORR) by Investigator Assessment | ORR was defined as the percentage of participants for each dose level whose best overall response is rated as CR or PR per RECIST v1.1. ORR assessment included: ORR with confirmed response ORR with unconfirmed response Participants who had CR or PR were considered to have confirmed response, and participants who did not meet this criterion were considered to have unconfirmed response. CR was defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be <10 mm in the short axis. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. |
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Inclusion Criteria:
Phase 1 Dose Escalation only:
- Participant has relapsed/refractory (R/R) solid tumor known to express NY-ESO-1 after completing available Standard of Care (SOC) therapy or is not a candidate for SOC therapy. NY-ESO-1 expression status is not required for participant entry.
Safety Lead-in, Phase 2 Single agent and Combination Therapy only:
Participant has relapsed/refractory (R/R) synovial sarcoma (SS) or myxoid/round cell liposarcoma (MRCL) disease after undergoing available SOC treatment or is not a candidate for SOC therapy (must have previously received either an anthracycline or ifosfamide containing regimen or another systemic regimen, if not a candidate for either agent).
Participant has R/R ovarian cancer that is:
Participant has R/R solid tumor (melanoma, non-small cell lung cancer [NSCLC]-adenocarcinoma and squamous cell, or esophageal squamous cell carcinoma [ESCC]) after available SOC treatment or is not a candidate for SOC therapy (single-agent only).
Participant consents to provide an archival tumor specimen in a tissue block or unstained serial slides prior to IP administration.
Participant in phase 2 consents to provide tumor specimen obtained within 56 days prior to first dose of study treatment, as tissue block or unstained serial slides.
Participant in phase 2 consents to undergoing a tumor biopsy (core needle biopsy or excision) during the treatment period.
Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of <= 2.
Participant with life expectancy of >= 12 weeks at the time of screening.
Participant must meet criteria for clinical laboratory tests during screening period.
A female participant is eligible to participate if she is not pregnant and at least one of the following conditions apply:
Female participant must not be breastfeeding at screening or during the study period and for 6 months after the final IP administration.
Female participant must not donate ova at screening and throughout the study period and for 6 months after the final IP administration.
A male participant with female partner(s) of childbearing potential must agree to use contraception during the treatment period and for at least 6 months after the final IP administration.
Male participant must not donate sperm starting at screening and throughout the study period and for 6 months after the final IP administration.
Participant agrees not to participate in another interventional study while on treatment.
Participant measurable disease according to RECIST 1.1. For participant with only 1 measurable lesion and prior radiotherapy, the lesion must be outside the field of prior radiotherapy or must have documented progression following radiation therapy.
Exclusion Criteria:
Participant has persistent non-hematological toxicities of >= grade 2 (National Cancer Institute's Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 5.0), with symptoms and objective findings from treatment (including chemotherapy, kinase inhibitors, immunotherapy, experimental agents, radiation or surgery).
Participant has received any of the following therapies (for inclusion in the study, all abnormalities must have returned to <= grade 1):
Participant has clinically active or untreated nervous system metastases. Participants with previously treated Central Nervous System (CNS) metastases are eligible, if they are clinically stable and have no evidence of CNS progression by imaging for at least 4 weeks prior to start of study treatment and are not requiring immunosuppressive doses of systemic steroids (> 30 mg per day of hydrocortisone or > 10 mg per day of prednisone or equivalent) for longer than 2 weeks.
Participant has an active autoimmune disease. Participant with type 1 diabetes mellitus, endocrinopathies stably maintained on appropriate replacement therapy, or skin disorders (e.g., vitiligo, psoriasis, or alopecia) not requiring systemic treatment are allowed.
Participant was discontinued from prior immunomodulatory therapy due to a grade >= 3 toxicity that was mechanistically related (e.g., immune related) to the agent.
Participant has known history of serious hypersensitivity reaction to a known ingredient of ASP0739 or pembrolizumab or severe hypersensitivity reaction to treatment with another monoclonal antibody.
Participant has a prior malignancy active (i.e., requiring treatment or intervention) within the previous 2 years prior to screening visit, except for locally curable malignancies that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast.
Participant has received a prior allogeneic bone marrow or solid organ transplant.
Participant has an active uncontrolled infection within 14 days of treatment.
Participant is known to have human immunodeficiency virus infection.
Participant has active hepatitis B or C or other active hepatic disorder or participant is on hepatitis treatment. Hepatitis C RNA testing is not required in participants with negative hepatitis C antibody testing.
Participant has any condition which makes the participant unsuitable for study participation.
Participant has had a major surgical procedure and has not completely recovered within 28 days prior to the start of study treatment.
Participant has had a myocardial infarction or unstable angina within 6 months prior to the start of study treatment or currently has an uncontrolled illness including, but not limited to, symptomatic congestive heart failure, clinically significant cardiac disease, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Participant is expected to require another form of anti-cancer therapy while on study treatment.
Participant has a known or suspected hypersensitivity to bovine-derived protein or has suspected hypersensitivity to any ingredients of ASP0739.
Additional Exclusion Criteria for Participants in Combination Therapy Cohorts
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Global Development, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| University of Miami |
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| Label | URL |
|---|---|
| Link to results and other applicable study documents on the Astellas Clinical Trials website | View source |
| Link to plain language summary of the study on the Trial Results Summaries website | View source |
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Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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Participants who met all inclusion criteria and none of the exclusion criteria were enrolled in the study. Study was terminated at dose expansion monotherapy after the comprehensive assessment of other studies that indicated the lack of sufficient monotherapy activity, therefore, team decided to terminate the study.
Participants with Relapsed/Refractory (R/R) solid tumors and with synovial sarcoma (SS), myxoid/round cell liposarcoma (MRCL), ovarian cancer and other solid tumors known to express New York esophageal squamous cell carcinoma 1 (NY-ESO-1) (melanoma, non-small cell lung cancer [NSCLC] adenocarcinoma and squamous cell and esophageal squamous cell carcinoma [ESCC]) were recruited.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL | Participants with R/R solid tumors known to express NY-ESO-1 received intravenous (IV) infusion of ASP0739 (human embryonic kidney cell [HEK293] transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^7 cells/milliliters (mL) at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a partial response (PR) or stable disease (SD) (1 cycle= 28 days). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Phase 1: Dose Escalation (168 Days) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 24, 2022 | May 22, 2024 |
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| At C1D2 |
| Number of Participants With ECOG Performance Status at C1D8 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| At C1D8 |
| Number of Participants With ECOG Performance Status at CID15 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| At CID15 |
| Number of Participants With ECOG Performance Status at CID22 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| At CID22 |
| Number of Participants With ECOG Performance Status at C2D1 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| At C2D1 |
| Number of Participants With ECOG Performance Status at C2D2 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| At C2D2 |
| Number of Participants With ECOG Performance Status at C2D8 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| At C2D8 |
| Number of Participants With ECOG Performance Status at C2D15 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| At C2D15 |
| Number of Participants With ECOG Performance Status at C2D22 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| At C2D22 |
| Number of Participants With ECOG Performance Status at C3D1 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| At C3D1 |
| Number of Participants With ECOG Performance Status at C3D8 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| At C3D8 |
| Number of Participants With ECOG Performance Status at C3D15 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| At C3D15 |
| Number of Participants With ECOG Performance Status at C3D22 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| At C3D22 |
| Number of Participants With ECOG Performance Status at C4D1 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| At C4D1 |
| Number of Participants With ECOG Performance Status at C4D8 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| At C4D8 |
| Number of Participants With ECOG Performance Status at C4D15 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| At C4D15 |
| Number of Participants With ECOG Performance Status at C4D22 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| At C4D22 |
| Number of Participants With ECOG Performance Status at C5D1 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| At C5D1 |
| Number of Participants With ECOG Performance Status at C5D15 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| At C5D15 |
| Number of Participants With ECOG Performance Status at C6D1 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| At C6D1 |
| Number of Participants With ECOG Performance Status at C6D15 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| At C6D15 |
| Number of Participants With ECOG Performance Status at End of Treatment (EOT) Visit | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| At EOT visit (day 175) |
| Number of Participants With ECOG Performance Status at Safety Follow up 30 Days | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| At 30 days safety follow up (day 198) |
| Number of Participants With ECOG Performance Status at Safety Follow up 60 Days | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| At 60 days safety follow up (day 228) |
| Number of Participants With ECOG Performance Status at Safety Follow up 90 Days | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| At 90 days safety follow up (day 258) |
| Recommended Phase 2 Dose (RP2D) | The dose recommended for use in phase 2 studies was analyzed on the basis of the safety, tolerability, and preliminary pharmacokinetic (PK) and efficacy data obtained in phase 1 studies. | C1D1 up to C1D28 |
| Objective Response Rate Per Immune Response Evaluation Criteria in Solid Tumors (iRECIST) (iORR) by Independent Central Review | iORR was defined as the percentage of participants for each dose level whose best overall response is rated as complete response (iCR) or partial response (iPR) per iRECIST. iORR assessments included:
iCR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. | From first dose up to 525 days |
| From first dose up to 525 days |
| Disease Control Rate Per iRECIST (iDCR) by Investigator Assessment | iDCR was defined as the percentage of participants for each dose level whose best overall response is rated as confirmed and unconfirmed iCR, iPR or stable disease (iSD) per iRECIST. iCR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 mm in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. SD was defined as neither sufficient shrinkage to qualify for iPR nor sufficient increase to qualify for progressive disease. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started. Participants who had CR or PR were considered to have confirmed response, and participants who did not meet this criterion were considered to have unconfirmed response. | From first dose up to 525 days |
| Disease Control Rate Per RECIST v1.1 (DCR) by Investigator Assessment | DCR is defined as the percentage of participants for each dose level whose best overall response is rated as confirmed CR, PR or SD per RECIST v1.1.CR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 mm in the short axis. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started. | From first dose up to 525 days |
| Progression-Free Survival Per iRECIST (iPFS) by Independent Central Review | iPFS is defined as the time from the date of first dose until death from any cause or radiographic disease progression assessed per iRECIST by independent central review. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started. | From first dose up to 525 days |
| iPFS Per iRECIST by Investigator Assessment | iPFS is defined as the time from the date of first dose until death from any cause or radiographic disease progression assessed per iRECIST by investigator assessment. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started. | From first dose up to 525 days |
| Progression-Free Survival Per RECIST v1.1 (PFS) by Investigator Assessment | PFS is defined as the time from the date of first dose until death from any cause or radiographic disease progression assessed per RECIST v1.1 by investigator assessment.Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started | From first dose up to 525 days |
| Duration of Overall Survival (OS) | OS is defined as the time from the date of first dose until the date of death from any cause (death date - first dose date + 1). For a participant who is not known to have died by the end of study follow-up, OS is censored at the date of last contact (date of last contact - first dose date + 1). | From first dose up to 525 days |
| Duration of Response Per iRECIST (iDOR) | iDOR as per iRECIST was defined as the time from the date of the first response iCR/iPR (whichever is first recorded) to the date of radiographical progression or date of censoring. iCR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 mm in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. | From first response up to 525 days |
| Duration of Response Per RECIST (DOR) v1.1 | DOR as per RECIST 1.1 was defined as the time from the date of the first response CR/PR (whichever is first recorded) to the date of radiographical progression or date of censoring. CR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 mm in the short axis. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. | From first response up to 525 days |
| ORR Per iRECIST (iORR) by Investigator Assessment | iORR was defined as the percentage of participants for each dose level whose best overall response is rated as iCR or iPR per iRECIST. iORR assessments included:
iCR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 mm in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. Participants who had CR or PR were considered to have confirmed response, and participants who did not meet this criterion were considered to have unconfirmed response. | From first dose up to 525 days |
| Miami |
| Florida |
| 33136 |
| United States |
| Northwestern University Robert H. Lurie Comprehensive Cancer Center | Chicago | Illinois | 60611 | United States |
| The University of Chicago Medicine | Chicago | Illinois | 60637 | United States |
| NYU Perlmutter Cancer Center | New York | New York | 10016 | United States |
| Brown University | Providence | Rhode Island | 02903 | United States |
| FG001 | Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL | Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
| FG002 | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
| COMPLETED |
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| NOT COMPLETED |
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| Phase 2: Dose Expansion (168 Days) |
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|
Safety Analysis Set (SAF). All participants who took at least 1 dose of the investigational product (IP).
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL | Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
| BG001 | Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL | Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
| BG002 | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
| BG003 | 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 |
| ||||||||||||||||
| Number of participants with Eastern Cooperative Oncology Group (ECOG) Performance Status | ECOG Scale was used to assess performance status. Grades: 0: Fully active, able to carry on all pre-disease performance without restriction. 1: Restricted in physically strenuous activity but ambulatory, able to carry out work of light nature. 2: Ambulatory, capable of self-care, unable to carry out work activities. Up and about more than 50% waking hours. 3: Capable of limited self-care, confined to bed/chair more than 50% waking hours. 4: Completely disabled. Cannot carry on any self-care. Totally confined to bed/chair. 5: Dead. Only participants with ECOG grades were reported. | Count of Participants | 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 | Number of Participants With Dose Limiting Toxicities (DLTs) | DLT was defined as any event occurring within 28 days of first dose on C1D1 and graded as:
| DLT Evaluation Analysis Set (DEAS).The DEAS was defined as all participants in SAF excluding participants who met any of the following criteria:
| Posted | Number | Participants | Cycle 1 Day 1 (C1D1) up to C1D28 |
|
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| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) & Serious Adverse Events (SAEs) | An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An AE was considered "serious" if, it resulted in any of the following outcomes: results in death; is life-threatening; results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly, or birth defect; requires inpatient hospitalization; or leads to prolongation of hospitalization; other medically important events. A treatment-emergent adverse event (TEAE) was defined as an AE observed after the date of first dose until 30 days after the last dose. | SAF | Posted | Number | Participants | From first dose up to 198 days |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With ECOG Performance Status at C1D2 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| SAF with available data analyzed. | Posted | Number | Participants | At C1D2 |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With ECOG Performance Status at C1D8 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| SAF | Posted | Number | Participants | At C1D8 |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With ECOG Performance Status at CID15 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| SAF with available data analyzed. | Posted | Number | Participants | At CID15 |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With ECOG Performance Status at CID22 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| SAF with available data analyzed. | Posted | Number | Participants | At CID22 |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With ECOG Performance Status at C2D1 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| SAF with available data analyzed. | Posted | Number | Participants | At C2D1 |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With ECOG Performance Status at C2D2 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| SAF with available data analyzed. | Posted | Number | Participants | At C2D2 |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With ECOG Performance Status at C2D8 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| SAF with available data analyzed. | Posted | Number | Participants | At C2D8 |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With ECOG Performance Status at C2D15 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| SAF with available data analyzed. | Posted | Number | Participants | At C2D15 |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With ECOG Performance Status at C2D22 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| SAF with available data analyzed. | Posted | Number | Participants | At C2D22 |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With ECOG Performance Status at C3D1 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| SAF with available data analyzed. | Posted | Number | Participants | At C3D1 |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With ECOG Performance Status at C3D8 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| SAF with available data analyzed. | Posted | Number | Participants | At C3D8 |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With ECOG Performance Status at C3D15 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| SAF with available data analyzed. | Posted | Number | Participants | At C3D15 |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With ECOG Performance Status at C3D22 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| SAF with available data analyzed. | Posted | Number | Participants | At C3D22 |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With ECOG Performance Status at C4D1 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| SAF with available data analyzed. | Posted | Number | Participants | At C4D1 |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With ECOG Performance Status at C4D8 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| SAF with available data analyzed. | Posted | Number | Participants | At C4D8 |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With ECOG Performance Status at C4D15 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| SAF with available data analyzed. | Posted | Number | Participants | At C4D15 |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With ECOG Performance Status at C4D22 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| SAF with available data analyzed. | Posted | Number | Participants | At C4D22 |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With ECOG Performance Status at C5D1 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| SAF with available data analyzed. | Posted | Number | Participants | At C5D1 |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With ECOG Performance Status at C5D15 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| SAF with available data analyzed. | Posted | Number | Participants | At C5D15 |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With ECOG Performance Status at C6D1 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| SAF with available data analyzed. | Posted | Number | Participants | At C6D1 |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With ECOG Performance Status at C6D15 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| SAF with available data analyzed. | Posted | Number | Participants | At C6D15 |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With ECOG Performance Status at End of Treatment (EOT) Visit | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| SAF with available data analyzed. | Posted | Number | Participants | At EOT visit (day 175) |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With ECOG Performance Status at Safety Follow up 30 Days | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| SAF with available data analyzed. | Posted | Number | Participants | At 30 days safety follow up (day 198) |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With ECOG Performance Status at Safety Follow up 60 Days | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| SAF with available data analyzed. | Posted | Number | Participants | At 60 days safety follow up (day 228) |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With ECOG Performance Status at Safety Follow up 90 Days | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction.
| SAF with available data analyzed. | Posted | Number | Participants | At 90 days safety follow up (day 258) |
| ||||||||||||||||||||||||||||||||||
| Primary | Recommended Phase 2 Dose (RP2D) | The dose recommended for use in phase 2 studies was analyzed on the basis of the safety, tolerability, and preliminary pharmacokinetic (PK) and efficacy data obtained in phase 1 studies. | SAF | Posted | Number | cells/mL | C1D1 up to C1D28 |
|
| |||||||||||||||||||||||||||||||||
| Primary | Objective Response Rate Per Immune Response Evaluation Criteria in Solid Tumors (iRECIST) (iORR) by Independent Central Review | iORR was defined as the percentage of participants for each dose level whose best overall response is rated as complete response (iCR) or partial response (iPR) per iRECIST. iORR assessments included:
iCR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. | Due to early termination of the study, sponsor decided not to collect data for endpoints that were assessed by independent central review, thus data was not reported. | Posted | From first dose up to 525 days |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (ORR) by Investigator Assessment | ORR was defined as the percentage of participants for each dose level whose best overall response is rated as CR or PR per RECIST v1.1. ORR assessment included: ORR with confirmed response ORR with unconfirmed response Participants who had CR or PR were considered to have confirmed response, and participants who did not meet this criterion were considered to have unconfirmed response. CR was defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be <10 mm in the short axis. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. | Response Analysis Set (RAS): The response analysis consisted of all participants who were enrolled and received at least one dose of IP and had at least one post baseline primary efficacy measurement. | Posted | Number | 95% Confidence Interval | Percentage of participants | From first dose up to 525 days |
| |||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate Per iRECIST (iDCR) by Investigator Assessment | iDCR was defined as the percentage of participants for each dose level whose best overall response is rated as confirmed and unconfirmed iCR, iPR or stable disease (iSD) per iRECIST. iCR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 mm in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. SD was defined as neither sufficient shrinkage to qualify for iPR nor sufficient increase to qualify for progressive disease. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started. Participants who had CR or PR were considered to have confirmed response, and participants who did not meet this criterion were considered to have unconfirmed response. | RAS | Posted | Number | 95% Confidence Interval | Percentage of participants | From first dose up to 525 days |
| |||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate Per RECIST v1.1 (DCR) by Investigator Assessment | DCR is defined as the percentage of participants for each dose level whose best overall response is rated as confirmed CR, PR or SD per RECIST v1.1.CR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 mm in the short axis. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started. | RAS | Posted | Number | 95% Confidence Interval | Percentage of participants | From first dose up to 525 days |
| |||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival Per iRECIST (iPFS) by Independent Central Review | iPFS is defined as the time from the date of first dose until death from any cause or radiographic disease progression assessed per iRECIST by independent central review. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started. | Due to early termination of the study, sponsor decided not to collect data for endpoints that were assessed by independent central review, thus data was not reported. | Posted | From first dose up to 525 days |
| ||||||||||||||||||||||||||||||||||||
| Secondary | iPFS Per iRECIST by Investigator Assessment | iPFS is defined as the time from the date of first dose until death from any cause or radiographic disease progression assessed per iRECIST by investigator assessment. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started. | FAS with available data analyzed. The dose level utilized during the expansion phase was the recommended phase 2 dose (RP2D), which was carefully selected from the dose escalation phase and a pooled population was used to estimate time-to-event efficacy endpoints for a comprehensive overview of the treatment's effectiveness | Posted | Median | 95% Confidence Interval | Days | From first dose up to 525 days |
| |||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival Per RECIST v1.1 (PFS) by Investigator Assessment | PFS is defined as the time from the date of first dose until death from any cause or radiographic disease progression assessed per RECIST v1.1 by investigator assessment.Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started | FAS with available data analyzed. The dose level utilized during the expansion phase was the RP2D, which was carefully selected from the dose escalation phase and a pooled population was used to estimate time-to-event efficacy endpoints for a comprehensive overview of the treatment's effectiveness. | Posted | Median | 95% Confidence Interval | Days | From first dose up to 525 days |
| |||||||||||||||||||||||||||||||||
| Secondary | Duration of Overall Survival (OS) | OS is defined as the time from the date of first dose until the date of death from any cause (death date - first dose date + 1). For a participant who is not known to have died by the end of study follow-up, OS is censored at the date of last contact (date of last contact - first dose date + 1). | FAS. The dose level utilized during the expansion phase was the RP2D, which was carefully selected from the dose escalation phase and a pooled population was used to estimate time-to-event efficacy endpoints for a comprehensive overview of the treatment's effectiveness. | Posted | Median | 95% Confidence Interval | Days | From first dose up to 525 days |
| |||||||||||||||||||||||||||||||||
| Secondary | Duration of Response Per iRECIST (iDOR) | iDOR as per iRECIST was defined as the time from the date of the first response iCR/iPR (whichever is first recorded) to the date of radiographical progression or date of censoring. iCR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 mm in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. | Due to early termination of the study, sponsor decided not to collect data for this endpoint, thus data was not reported. | Posted | From first response up to 525 days |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response Per RECIST (DOR) v1.1 | DOR as per RECIST 1.1 was defined as the time from the date of the first response CR/PR (whichever is first recorded) to the date of radiographical progression or date of censoring. CR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 mm in the short axis. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. | Due to early termination of the study, sponsor decided not to collect data for this endpoint, thus data was not reported. | Posted | From first response up to 525 days |
| ||||||||||||||||||||||||||||||||||||
| Secondary | ORR Per iRECIST (iORR) by Investigator Assessment | iORR was defined as the percentage of participants for each dose level whose best overall response is rated as iCR or iPR per iRECIST. iORR assessments included:
iCR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 mm in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. Participants who had CR or PR were considered to have confirmed response, and participants who did not meet this criterion were considered to have unconfirmed response. | RAS | Posted | Number | 95% Confidence Interval | Percentage of participants | From first dose up to 525 days |
|
For AEs: From first dose up to 198 days. For All-cause mortality: From first dose up to 525 days
SAF. First dose took place at the same time as randomization.
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 | Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL | Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). | 3 | 4 | 1 | 4 | 4 | 4 |
| EG001 | Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL | Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). | 2 | 7 | 2 | 7 | 7 | 7 |
| EG002 | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). | 1 | 5 | 1 | 5 | 4 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.1 | Systematic Assessment |
| |
| Renal disorder | Renal and urinary disorders | MedDRA v23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Eructation | Gastrointestinal disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v23.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v23.1 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA v23.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v23.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v23.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v23.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA v23.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA v23.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA v23.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v23.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA v23.1 | Systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA v23.1 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA v23.1 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA v23.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA v23.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v23.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v23.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v23.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v23.1 | Systematic Assessment |
|
Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Transparency | Astellas Pharma Global Development Inc | 8008887704 | astellas.resultsdisclosure@astellas.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 22, 2023 | Jul 11, 2024 | SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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 |
|
| Grade 1 |
|
| Grade 2 |
|
| Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL |
Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
| OG002 | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
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| OG002 | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
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| OG002 | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
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| OG002 | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
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| OG002 | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
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| OG002 | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
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| OG002 | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
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| OG002 | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
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| OG002 | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
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| OG002 | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
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| OG002 | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
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| OG002 | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
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| OG002 | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
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| OG002 | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
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| OG002 | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
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| OG002 | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
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| OG002 | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
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| OG002 | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
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| OG002 | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
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| OG002 | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
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| OG002 | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
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| OG002 | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
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| OG002 | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
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| OG002 | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
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| OG002 | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
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| OG002 | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
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| OG002 | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
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| Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL |
Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
| OG002 | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
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| Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL |
Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
| OG002 | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
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Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).
| OG002 | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
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| OG002 | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
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| OG002 | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
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| OG002 | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
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| OG002 | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
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