Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06685068 | RECRUITING | Advanced Solid Tumor

A Phase 1/2 Study of GEN1286 in Patients With Advanced Solid Tumors
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

Condition or disease

Advanced Solid Tumor

Intervention/treatment

GEN1286

Phase

PHASE1

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 260 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 1/2 Study of GEN1286 in Patients With Advanced Solid Tumors
Actual Study Start Date : 2024-11-13
Estimated Primary Completion Date : 2028-05-29
Estimated Study Completion Date : 2028-06-29

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Key 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).
  • Key Exclusion Criteria
    • * Prior treatment with topoisomerase 1-based antibody-drug conjugate (ADC) therapy.
    • Note: Other protocol-defined inclusion and exclusion criteria may apply.
A Phase 1/2 Study of GEN1286 in Patients With Advanced Solid Tumors

Location Details

NCT06685068

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Road cancer

START Midwest

Grand Rapids, Road cancer, United States, 49546

RECRUITING

United States, Texas

START San Antonio

San Antonio, Texas, United States, 78229

RECRUITING

United States, Utah

START Mountain Region

West Valley City, Utah, United States, 84119