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This study evaluates the anti-tumor effects of ALRN-6924 in patients with advanced solid tumors or lymphomas with WT TP53.
Open label, multi center, Phase 1 (dose escalation) and Phase 2a (dose expansion) study design to evaluate safety, tolerability, PK, PD and anti-tumor effects of ALRN-6924, alone or in combination with palbociclib, in patients with advanced solid tumors or lymphomas with wild-type (WT) TP53. ALRN-6924 is a stabilized cell-permeating peptide designed to disrupt the interaction between the p53 tumor suppressor protein and its predominant endogenous inhibitors, murine double minute 2 (MDM2) and murine double minute X (MDMX).
The Phase 1 portion of the study will enroll adults with histologically or cytologically confirmed malignancies that are metastatic or unresectable and for which standard treatment(s) are not available or are no longer effective. The Phase 2a portion of the study consists of separate cohorts that will enroll distinct groups of patients with specific solid tumors and/or lymphomas to further investigate the clinical safety profile and potential efficacy of ALRN-6924 alone or in a combination regimen.
Treatment will continue until unacceptable toxicity, patient or physician decision to discontinue therapy or disease progression that is either symptomatic, rapidly progressive, requires urgent intervention or is associated with a decline in performance status.
Patients with PTCL have been selected as a group to be further studied in Phase 2a.
Patients with MDM2-amplified or MDM2/CDK4-co-amplified solid tumors have been selected as another group to be further studied in Phase 2a.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Regimen A (DR-A) | Experimental | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. |
|
| Dose Regimen B (DR-B) | Experimental | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle |
|
| Dose Regimen C (DR-C) | Experimental | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 3 and 5 of a 21-day cycle |
|
| Combination with palbociclib | Experimental | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle Drug: Palbociclib Fixed-dose capsule administered orally on days 1 through 21 of a 28-day cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALRN-6924 | Drug | ALRN-6924 will be administered as an IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the Safety and Tolerability of ALRN-6924 in Adult Patients With Advanced Solid Tumors or Lymphomas With Wild-type (WT) TP53 Who Are Refractory to or Intolerant of Standard Therapy, or for Whom no Standard Therapy Exists | Number of participants with treatment-related adverse events as assessed by CTCAE v.4.0 | From Day 1 of treatment until 30 days after the last cycle of treatment (each cycle in DR-A is 28 days, DR-B and DR-C is 21 days), an average of 138 Days |
| Evaluate the Safety and Tolerability of ALRN-6924 in Adult Patients With Advanced Solid Tumors or Lymphomas With Wild-type (WT) TP53 Who Are Refractory to or Intolerant of Standard Therapy, or for Whom no Standard Therapy Exists, Expansion | Number of participants with treatment-related adverse events as assessed by CTCAE v.4.0 | From Day 1 of treatment until 30 days after the last cycle of treatment (each cycle in DR-A is 28 days, DR-B and DR-C is 21 days), an average of 138 Days |
| Determine the Maximum Tolerated Dose (MTD) of ALRN-6924 in Adult Patients With Advanced Solid Tumors or Lymphomas | Determine the maximum tolerated dose (MTD) | From Day 1 of treatment until 30 days after the last cycle of treatment (each cycle in DR-A is 28 days, DR-B and DR-C is 21 days), an average of 138 Days |
| Determine Overall Response Rate | The proportion of efficacy-evaluable patients who achieve complete response (CR) or partial response (PR), per investigator assessment, in accordance with RECIST 1.1 or iRECIST (for solid tumor patients) or Response Assessment in Neuro-Oncology (RANO) criteria (for glioblastoma patients). | From Day 1 of treatment until 30 days after the last cycle of treatment (each cycle in DR-A is 28 days, DR-B and DR-C is 21 days), an average of 138 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Assess Additional Measures of Anti-tumor Activity, Including Duration of Response, Progression Free Survival, Overall Survival and Time to Response | The proportion of efficacy-evaluable patients who achieve complete response (CR) or partial response (PR), per investigator assessment, in accordance with RECIST 1.1 or iRECIST (for solid tumor patients) or Response Assessment in Neuro-Oncology (RANO) criteria (for glioblastoma patients). |
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Inclusion Criteria
Key Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35294 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34230007 | Derived | Zhou X, Singh M, Sanz Santos G, Guerlavais V, Carvajal LA, Aivado M, Zhan Y, Oliveira MMS, Westerberg LS, Annis DA, Johnsen JI, Selivanova G. Pharmacologic Activation of p53 Triggers Viral Mimicry Response Thereby Abolishing Tumor Immune Evasion and Promoting Antitumor Immunity. Cancer Discov. 2021 Dec 1;11(12):3090-3105. doi: 10.1158/2159-8290.CD-20-1741. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose Regimen A (DR-A) Escalation (0.16 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| FG001 | Dose Regimen A (DR-A) Escalation (0.32 mg/kg) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Sep 25, 2018 | Nov 26, 2024 |
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| From Day 1 of treatment until 30 days after the last cycle of treatment (each cycle in DR-A is 28 days, DR-B and DR-C is 21 days), an average of 138 Days |
| Determine Pharmacokinetic Parameters of ALRN-6924 When Administered to Patients With Advanced Solid Tumors or Lymphomas | Time of Peak Plasma Concentration (Tmax) | 8 weeks |
| Duarte |
| California |
| 91010 |
| United States |
| Denver | Colorado | 80218 | United States |
| Sarasota | Florida | 34232 | United States |
| Tampa | Florida | 33612 | United States |
| Boston | Massachusetts | 02114 | United States |
| Boston | Massachusetts | 02215 | United States |
| New York | New York | 10065 | United States |
| The Bronx | New York | 10461 | United States |
| Greenville | South Carolina | 29605 | United States |
| Nashville | Tennessee | 37203 | United States |
| Houston | Texas | 77030 | United States |
| Seattle | Washington | 98105 | United States |
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| FG002 | Dose Regimen A (DR-A) Escalation (0.64 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| FG003 | Dose Regimen A (DR-A) Escalation (1.25 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| FG004 | Dose Regimen A (DR-A) Escalation (2.10 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| FG005 | Dose Regiment A (DR-A) Escalation (3.10 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| FG006 | Dose Regimen A (DR-A) Escalation (4.40 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| FG007 | Dose Regimen B (DR-B) Escalation (0.32 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| FG008 | Dose Regimen B (DR-B) Escalation (0.53 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| FG009 | Dose Regimen B (DR-B) Escalation (0.80 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| FG010 | Dose Regimen B (DR-B) Escalation (1.10 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| FG011 | Dose Regimen B (DR-B) Escalation (1.50 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| FG012 | Dose Regimen B (DR-B) Escalation (2.00 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| FG013 | Dose Regimen B (DR-B) Escalation (2.70 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| FG014 | Dose Regimen A (DR-A) PTCL Expansion | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| FG015 | Dose Regimen C (DR-C) PTCL Expansion | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 3 and 5 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| FG016 | Combination With Palbociclib Expansion | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle Drug: Palbociclib Fixed-dose capsule administered orally on days 1 through 21 of a 28-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose Regimen A (DR-A) Escalation (0.16 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| BG001 | Dose Regimen A (DR-A) Escalation (0.32 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| BG002 | Dose Regimen A (DR-A) Escalation (0.64 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| BG003 | Dose Regimen A (DR-A) Escalation (1.25 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| BG004 | Dose Regimen A (DR-A) Escalation (2.10 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| BG005 | Dose Regimen A (DR-A) Escalation (3.10 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| BG006 | Dose Regimen A (DR-A) Escalation (4.40 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| BG007 | Dose Regimen B (DR-B) Escalation (0.32 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| BG008 | Dose Regimen B (DR-B) Escalation (0.53 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| BG009 | Dose Regimen B (DR-B) Escalation (0.80 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| BG010 | Dose Regimen B (DR-B) Escalation (1.10 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| BG011 | Dose Regimen B (DR-B) Escalation (1.50 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| BG012 | Dose Regimen B (DR-B) Escalation (2.00 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| BG013 | Dose Regimen B (DR-B) Escalation (2.70 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| BG014 | Dose Regimen A (DR-A) PTCL Expansion | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| BG015 | Dose Regimen C (DR-C) PTCL Expansion | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 3 and 5 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| BG016 | Combination With Palbociclib Expansion | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle Drug: Palbociclib Fixed-dose capsule administered orally on days 1 through 21 of a 28-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| BG017 | 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 |
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| 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 | Evaluate the Safety and Tolerability of ALRN-6924 in Adult Patients With Advanced Solid Tumors or Lymphomas With Wild-type (WT) TP53 Who Are Refractory to or Intolerant of Standard Therapy, or for Whom no Standard Therapy Exists | Number of participants with treatment-related adverse events as assessed by CTCAE v.4.0 | Posted | Count of Participants | Participants | From Day 1 of treatment until 30 days after the last cycle of treatment (each cycle in DR-A is 28 days, DR-B and DR-C is 21 days), an average of 138 Days |
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| Primary | Evaluate the Safety and Tolerability of ALRN-6924 in Adult Patients With Advanced Solid Tumors or Lymphomas With Wild-type (WT) TP53 Who Are Refractory to or Intolerant of Standard Therapy, or for Whom no Standard Therapy Exists, Expansion | Number of participants with treatment-related adverse events as assessed by CTCAE v.4.0 | Posted | Count of Participants | Participants | From Day 1 of treatment until 30 days after the last cycle of treatment (each cycle in DR-A is 28 days, DR-B and DR-C is 21 days), an average of 138 Days |
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| Primary | Determine the Maximum Tolerated Dose (MTD) of ALRN-6924 in Adult Patients With Advanced Solid Tumors or Lymphomas | Determine the maximum tolerated dose (MTD) | Posted | Number | mg/kg | From Day 1 of treatment until 30 days after the last cycle of treatment (each cycle in DR-A is 28 days, DR-B and DR-C is 21 days), an average of 138 Days |
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| Primary | Determine Overall Response Rate | The proportion of efficacy-evaluable patients who achieve complete response (CR) or partial response (PR), per investigator assessment, in accordance with RECIST 1.1 or iRECIST (for solid tumor patients) or Response Assessment in Neuro-Oncology (RANO) criteria (for glioblastoma patients). | Posted | Count of Participants | Participants | From Day 1 of treatment until 30 days after the last cycle of treatment (each cycle in DR-A is 28 days, DR-B and DR-C is 21 days), an average of 138 Days |
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| Secondary | Assess Additional Measures of Anti-tumor Activity, Including Duration of Response, Progression Free Survival, Overall Survival and Time to Response | The proportion of efficacy-evaluable patients who achieve complete response (CR) or partial response (PR), per investigator assessment, in accordance with RECIST 1.1 or iRECIST (for solid tumor patients) or Response Assessment in Neuro-Oncology (RANO) criteria (for glioblastoma patients). | The efficacy evaluable population was defined as those patients who met all of the following criteria: (1) Received at least 1 dose of ALRN-6924 at a dose level at least 0.8 mg/kg per infusion (2) Had at least 1 postbaseline evaluation or had clinical disease progression (3) Were TP53 wild type or indeterminate (as assessed by the central laboratory; if not assessed by central laboratory, as assessed by the local laboratory. | Posted | Count of Participants | Participants | From Day 1 of treatment until 30 days after the last cycle of treatment (each cycle in DR-A is 28 days, DR-B and DR-C is 21 days), an average of 138 Days |
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| Secondary | Determine Pharmacokinetic Parameters of ALRN-6924 When Administered to Patients With Advanced Solid Tumors or Lymphomas | Time of Peak Plasma Concentration (Tmax) | The Pharmacokinetic Analysis Population included all subjects who received at least one dose of ALRN-6924 with sufficient plasma sample data to assess PK parameters, and with no major protocol violations. Plasma samples for subjects in the Combination With Palbociclib Expansion arm were collected but will not be processed or analyzed due to a protocol-level decision for this expansion arm to discontinue pharmacokinetic data collection. | Posted | Median | Full Range | hour | 8 weeks |
|
From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dose Regimen A (DR-A) Escalation (0.16 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion | 0 | 5 | 0 | 5 | 5 | 5 |
| EG001 | Dose Regimen A (DR-A) Escalation (0.32 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion | 0 | 3 | 0 | 3 | 3 | 3 |
| EG002 | Dose Regimen A (DR-A) Escalation (0.64 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion | 0 | 4 | 0 | 4 | 4 | 4 |
| EG003 | Dose Regimen A (DR-A) Escalation (1.25 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion | 0 | 3 | 1 | 3 | 3 | 3 |
| EG004 | Dose Regimen A (DR-A) Escalation (2.1 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion | 0 | 6 | 0 | 6 | 6 | 6 |
| EG005 | Dose Regimen A (DR-A) Escalation (3.1 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion | 0 | 9 | 2 | 9 | 9 | 9 |
| EG006 | Dose Regimen A (DR-A) Escalation (4.4 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion | 0 | 11 | 4 | 11 | 11 | 11 |
| EG007 | Dose Regimen B (DR-B) Escalation (0.32 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion | 0 | 3 | 0 | 3 | 3 | 3 |
| EG008 | Dose Regimen B (DR-B) Escalation (0.53 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion | 0 | 5 | 1 | 5 | 5 | 5 |
| EG009 | Dose Regimen B (DR-B) Escalation (0.8 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion | 0 | 3 | 0 | 3 | 3 | 3 |
| EG010 | Dose Regimen B (DR-B) Escalation (1.1 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion | 0 | 4 | 0 | 4 | 4 | 4 |
| EG011 | Dose Regimen B (DR-B) Escalation (1.5 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion | 0 | 4 | 0 | 4 | 4 | 4 |
| EG012 | Dose Regimen B (DR-B) Escalation (2.0 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion | 0 | 5 | 0 | 5 | 5 | 5 |
| EG013 | Dose Regimen B (DR-B) Escalation (2.7 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion | 0 | 6 | 0 | 6 | 6 | 6 |
| EG014 | Dose Regimen A (DR-A) PTCL Expansion | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion | 0 | 21 | 7 | 21 | 19 | 21 |
| EG015 | Dose Regimen C (DR-C) PTCL Expansion | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 3 and 5 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion | 0 | 16 | 7 | 16 | 15 | 16 |
| EG016 | Combination With Palbociclib Expansion | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle Drug: Palbociclib Fixed-dose capsule administered orally on days 1 through 21 of a 28-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion | 5 | 34 | 5 | 34 | 34 | 34 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hypotension | Vascular disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| thrombocytopenia | Blood and lymphatic system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Vomitting | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| AKI | Endocrine disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| hypercalcemia | Blood and lymphatic system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Subarachnoid Hemorrhage | Blood and lymphatic system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Subdural Hemorrhage | Blood and lymphatic system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Hyponatraemia | Blood and lymphatic system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| CDIFF | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Histiocytosis Hamatophagic | Blood and lymphatic system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Hypokalemia | Blood and lymphatic system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Hyperbilirubinemia | Blood and lymphatic system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Atrial Fibrulation | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Escherichia bacteremia | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| CVA | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Pseudomonal bacteremia | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
| |
| Tongue Hemorrhage | Blood and lymphatic system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (19.1) | Non-systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Pelvic Pain | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Pyrexia | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Vomitting | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| anemia | Blood and lymphatic system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| thrombocytopenia | Blood and lymphatic system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Infusion Related Reaction | Injury, poisoning and procedural complications | MedDRA (19.1) | Non-systematic Assessment |
| |
| Hyperbilirubinemia | Hepatobiliary disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA (19.1) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Allen Annis | Consultant | 617-921-9467 | aannis@aileronrx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 13, 2018 | Nov 26, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
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 |
|
|
|
|
|
| OG002 | Dose Regimen A (DR-A) Escalation (0.64 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| OG003 | Dose Regimen A (DR-A) Escalation (1.25 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| OG004 | Dose Regimen A (DR-A) Escalation (2.10 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| OG005 | Dose Regimen A (DR-A) Escalation (3.10 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| OG006 | Dose Regimen A (DR-A) Escalation (4.40 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| OG007 | Dose Regimen B (DR-B) Escalation (0.32 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| OG008 | Dose Regimen B (DR-B) Escalation (0.53 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| OG009 | Dose Regimen B (DR-B) Escalation (0.80 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| OG010 | Dose Regimen B (DR-B) Escalation (1.10 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| OG011 | Dose Regimen B (DR-B) Escalation (1.50 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| OG012 | Dose Regimen B (DR-B) Escalation (2.00 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| OG013 | Dose Regimen B (DR-B) Escalation (2.70 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| OG014 | Dose Regimen A (DR-A) PTCL Expansion | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| OG015 | Dose Regimen C (DR-C) PTCL Expansion | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 3 and 5 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| OG016 | Combination With Palbociclib Expansion | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle Drug: Palbociclib Fixed-dose capsule administered orally on days 1 through 21 of a 28-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion |
|
|
| OG003 | Dose Regimen A (DR-A) Escalation (1.25 mg/kg) Escalation | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| OG004 | Dose Regimen A (DR-A) Escalation (2.10 mg/kg) Escalation | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| OG005 | Dose Regimen A (DR-A) Escalation (3.10 mg/kg) Escalation | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| OG006 | Dose Regimen A (DR-A) Escalation (4.40 mg/kg) Escalation | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| OG007 | Dose Regimen B (DR-B) Escalation (0.32 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| OG008 | Dose Regimen B (DR-B) Escalation (0.53 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| OG009 | Dose Regimen B (DR-B) Escalation (0.80 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| OG010 | Dose Regimen B (DR-B) Escalation (1.10 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| OG011 | Dose Regimen B (DR-B) Escalation (1.50 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| OG012 | Dose Regimen B (DR-B) Escalation (2.00 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| OG013 | Dose Regimen B (DR-B) Escalation (2.70 mg/kg) | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| OG014 | Dose Regimen A (DR-A) PTCL Expansion | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| OG015 | Dose Regimen C (DR-C) PTCL Expansion | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 3 and 5 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion |
| OG016 | Combination With Palbociclib Expansion | Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle Drug: Palbociclib Fixed-dose capsule administered orally on days 1 through 21 of a 28-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion |
|
|