A Phase 1/2 Study of GEN1286 in Patients With Advanced Solid Tumors
Purpose
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
Condition
- Advanced Solid Tumor
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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).
Exclusion Criteria
- Prior treatment with topoisomerase 1-based antibody-drug conjugate (ADC) therapy. Note: Other protocol-defined inclusion and exclusion criteria may apply.
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Sequential Assignment
- Intervention Model Description
- 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.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental GEN1286 |
|
Recruiting Locations
START Midwest
Grand Rapids, Michigan 49546
Grand Rapids, Michigan 49546
START San Antonio
San Antonio, Texas 78229
San Antonio, Texas 78229
START Mountain Region
West Valley City, Utah 84119
West Valley City, Utah 84119
More Details
- NCT ID
- NCT06685068
- Status
- Recruiting
- Sponsor
- Genmab