A Phase 1/2 Study of GEN1286 in Patients With Advanced Solid Tumors
- Registration Number
- NCT06685068
- Lead Sponsor
- Genmab
- Brief Summary
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:
* Part A: Dose escalation and dose level expansion
* Part B: Tumor-specific expansion with dose optimization
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 260
- Participants must be ≥ 18 years of age at the time of informed consent; have measurable disease according to RECIST 1.1; Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1; adequate organ, bone marrow, liver, coagulation, and renal function; and be willing to provide a pretreatment tumor specimen.
- All participants must have pathologically confirmed diagnosis of advanced solid tumor.
- Participants must have metastatic or unresectable locally advanced, recurrent disease not amenable to further local therapy and must have previously received therapies known to confer clinical benefit (unless ineligible to receive, refused to receive, or therapy is unavailable in the region).
Key
- Prior treatment with topoisomerase 1-based antibody-drug conjugate (ADC) therapy.
Note: Other protocol-defined inclusion and exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description GEN1286 GEN1286 -
- Primary Outcome Measures
Name Time Method 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) During first cycle (Cycle length=21 days) Toxicities will be graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 5.0.
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR) Up to approximately 3 years 9 months 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.
Disease Control Rate (DCR) Up to approximately 3 years 9 months 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.
Progression Free Survival (PFS) Up to approximately 3 years 9 months 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.
Duration of Objective Response (DOR) Up to approximately 3 years 9 months 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.
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
Trial Locations
- Locations (3)
START Midwest
🇺🇸Grand Rapids, Michigan, United States
START San Antonio
🇺🇸San Antonio, Texas, United States
START Mountain Region
🇺🇸West Valley City, Utah, United States