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

Description

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

Conditions

Advanced Solid Tumor

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Advanced Solid Tumor
Intervention / Treatment

-

Contacts and Locations

Grand Rapids

START Midwest, Grand Rapids, Michigan, United States, 49546

San Antonio

START San Antonio, San Antonio, Texas, United States, 78229

West Valley City

START Mountain Region, West Valley City, Utah, United States, 84119

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • * Prior treatment with topoisomerase 1-based antibody-drug conjugate (ADC) therapy.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Genmab,

Study Official, STUDY_DIRECTOR, Genmab

Study Record Dates

2028-06-29