RecruitingPhase 1

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

United States, Spain121 participantsStarted 2026-04-07

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Key Inclusion Criteria: All Parts: * Must have histologically confirmed selected solid cancers. * Have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The measurable lesion(s) must be outside the field of prior radiation therapy unless there is documented progression in the lesion(s). * Must provide formalin-fixed paraffin-embedded tumor tissue (aspirates and bone specimens are not acceptable), archival or fresh, collected after discontinuation of their most recent anticancer treatment and prior to the first administration of GEN1079. If an archival specimen is unavailable, a procedure for obtaining a fresh tumor biopsy must be performed, provided it is performed according to standard of care and is deemed safe by the investigator. * Has acceptable laboratory test results prior to trial treatment administration, including platelet count \>150×10\^9/litre (L). Parts 1 and 2: * Have histologically confirmed selected solid cancers that are metastatic or unresectable. * Prior protocol defined therapy is permitted, with no restrictions on the number of prior lines of therapy received or the time since the most recent therapy. Part 3: * Have histologically confirmed selected solid cancer that is metastatic or unresectable. * Must have received a defined number of prior lines of a protocol defined regimen. Key Exclusion Criteria: * Has intercurrent illness or known history of any of the following that could affect compliance with t…

What they're measuring

Part 1 Dose Escalation: Number of Participants with Dose-limiting Toxicities (DLTs)

Timeframe: 21 days

Part 1 Dose Escalation and Part 2 Dose Refinement: Number of Participants with Adverse Events (AEs)

Timeframe: Up to a maximum of approximately 67 weeks

Part 3 Expansion: Objective Response Rate (ORR)

Timeframe: Up to a maximum of approximately 67 months

Trial details

NCT IDNCT07387068

SponsorGenmab

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2031-01

Contact for this trial

Genmab Trial Information

+4570202728 clinicaltrials@genmab.com

View on ClinicalTrials.gov More Advanced Solid Tumors trials