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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20250215 | Registry Identifier | China Drug Trials | |
| PRO1286-001 | Other Identifier | Sponsor identifier |
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Genmab has decided to terminate the GEN1286 program due to an unfavorable benefit-risk profile not supporting further development.
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The purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics (PK), anti-tumor activity and immunogenic potential of GEN1286 in participants with advanced solid tumors.
This trial consists of 2 parts:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GEN1286 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GEN1286 | Drug | Specified dose on specified days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | From first dose until 12 months post last dose of study drug or withdrawal of consent, death, or study closure, whichever occurs first (Up to approximately 3 years 9 months) | |
| Number of Participants With Dose Limiting Toxicities (DLTs) | Toxicities will be graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 5.0. | During first cycle (Cycle length=21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR is defined as the percentage of participants achieving a partial response (PR) or complete response (CR) as assessed by the investigator based on response evaluation criteria in solid tumors (RECIST) version 1.1. | Up to approximately 3 years 9 months |
| Disease Control Rate (DCR) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
- Prior treatment with topoisomerase 1-based antibody-drug conjugate (ADC) therapy.
Note: Other protocol-defined inclusion and exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Study Official | Genmab | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| START Midwest |
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No randomization will be performed in Part A (dose escalation- sequential assignment). In Part B (tumor-specific expansion- parallel assignment), participants in each cohort will be randomized with a 1:1 ratio to receive one of the expansion doses of GEN1286.
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DCR is defined as the percentage of participants with stable disease (SD) or achieving a PR or CR based on RECIST version 1.1 as assessed by the investigator. |
| Up to approximately 3 years 9 months |
| Progression Free Survival (PFS) | PFS is defined as the time from the start of any treatment to the date of the first documented progression or death due to any cause, whichever occurs first based on RECIST version 1.1 as assessed by the investigator. | Up to approximately 3 years 9 months |
| Duration of Objective Response (DOR) | DOR is defined as the time from the first documentation of an objective tumor response (CR or PR) to the first documentation of tumor progression or to death due to any cause, whichever comes first based on RECIST version 1.1 as assessed by the investigator. | Up to approximately 3 years 9 months |
| Area Under the Plasma or Serum Concentration Time Curve (AUC) of GEN1286 Related Analytes- Antibody-Conjugated Exatecan, Total Antibody (Tab) and u-Exatecan | Predose and postdose at multiple timepoints at end of each cycle, up to approximately 2 years 9 months (Cycle length=21 days) |
| Maximum Observed Plasma or Serum Concentration (Cmax) of GEN1286 Related Analytes- Antibody-Conjugated Exatecan, Tab and u-Exatecan | Predose and postdose at multiple timepoints at end of each cycle, up to approximately 2 years 9 months (Cycle length=21 days) |
| Time to Reach Cmax (Tmax) of GEN1286 Related Analytes- Antibody-Conjugated Exatecan, Tab and u-Exatecan | Predose and postdose at multiple timepoints at end of each cycle, up to approximately 2 years 9 months (Cycle length=21 days) |
| Apparent Terminal Half-life (t1/2) of GEN1286 Related Analytes- Antibody-Conjugated Exatecan, Tab and u-Exatecan | Predose and postdose at multiple timepoints at end of each cycle, up to approximately 2 years 9 months (Cycle length=21 days) |
| Clearance (CL) of GEN1286 Related Analytes- Antibody-conjugated Exatecan, Tab and u-Exatecan | Predose and postdose at multiple timepoints at end of each cycle, up to approximately 2 years 9 months (Cycle length=21 days) |
| Volume of Distribution (Vz) of GEN1286 Related Analytes- Antibody-conjugated Exatecan, Tab and u-Exatecan | Predose and postdose at multiple timepoints at end of each cycle, up to approximately 2 years 9 months (Cycle length=21 days) |
| Trough Concentrations (Ctrough) of GEN1286 Related Analytes- Antibody-conjugated Exatecan, Tab and u-Exatecan | Predose and postdose at multiple timepoints at end of each cycle, up to approximately 2 years 9 months (Cycle length=21 days) |
| Number of Participants with Antidrug Antibodies (ADA) to GEN1286 | Up to approximately 2 years 9 months |
| Grand Rapids |
| Michigan |
| 49546 |
| United States |
| START San Antonio | San Antonio | Texas | 78229 | United States |
| START Mountain Region | West Valley City | Utah | 84119 | United States |