ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2024-11-13
Study Completion:2028-06-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06685068

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * All participants must have pathologically confirmed diagnosis of advanced solid tumor.
  3. * 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).
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Study Official
STUDY_DIRECTOR
Genmab

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
START Midwest
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

Collaborators and Investigators

Sponsor: Genmab

  • Study Official, STUDY_DIRECTOR, Genmab

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-13
Study Completion Date2028-06-29

Study Record Updates

Study Start Date2024-11-13
Study Completion Date2028-06-29

Terms related to this study

Additional Relevant MeSH Terms

  • Advanced Solid Tumor