Trial to Evaluate the Safety and Preliminary Efficacy of GEN1079 in Participants With Advanced Solid Tumors

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Genmab
Study ID
NCT07387068
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GEN1079 — DRUG
    Concentrate for solution.

Study Details

The purpose of this trial is to learn about the safety and effectiveness of the antibody GEN1079 in participants with certain types of cancer. The trial has multiple parts. The first part of the trial tests different doses of GEN1079 to find out if it is safe and determine what are the best doses to use. The second and third parts continue to test the safety of and whether GEN1079 works in additional participants with specific cancer types and at doses chosen based on results from the previous parts of the trial. For each participant, the trial will last approximately 33 to 67 weeks but this may vary for each person. This includes up to 21 days for screening prior to receiving trial treatment, approximately 6 to 12 weeks of treatment (the duration of treatment may vary for each participant), and approximately 24 to 52 weeks of follow up after trial treatment ends (the duration of follow up may vary for each participant). During the screening, tumor tissue either collected prior to this trial or freshly collected during screening will be provided by all participants. Participation in the trial will require visits to the site, with more frequent visits at the start of treatment and then less frequent visits afterwards. At site visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity, computed tomography \[CT\] scans) to monitor whether the treatment is safe and effective. All participants will receive active drug; no one will be given placebo.

Key Dates

Start date
Apr 7, 2026
Status verified
Jun 2026
Primary completion
Jan 31, 2031
Completion
Jan 31, 2031

Study Design

Enrollment
121 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: GEN1079 Dose Escalation
    Cohorts of participants will receive escalating doses of GEN1079 in up to 5 DLs.
  • Experimental: Part 2: GEN1079 Dose Refinement
    Cohorts of participants will receive up to 3 DLs of based on data from the Dose Escalation.
  • Experimental: Part 3: Expansion
    Cohorts of participants will receive up to 2 DLs of GEN1079 based on data from Dose Escalation/Dose Refinement.

Primary Outcome Measure

Part 1 Dose Escalation: Number of Participants with Dose-limiting Toxicities (DLTs) [ Time Frame: 21 days ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06520-
START Midwest, LLCGrand RapidsMichigan49546-
START New YorkLake SuccessNew York11042-

Find similar trials in New Haven, CT

By research site
Yale University· New Haven, CTSTART Midwest, LLC· Grand Rapids, MISTART New York· Lake Success, NY

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