NCT07695831 A Phase 1 Trial of GEN1119 in Participants With Solid Tumors
| NCT ID | NCT07695831 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Genmab |
| Condition | Solid Tumours |
| Study Type | INTERVENTIONAL |
| Enrollment | 112 participants |
| Start Date | 2026-08-13 |
| Primary Completion | 2029-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 112 participants in total. It began in 2026-08-13 with a primary completion date of 2029-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this trial is to learn about the safety and efficacy of GEN1119 when it is used for the treatment of participants with certain types of cancer. The trial has multiple parts. The first part of the trial will test different doses of GEN1119 to find out if it is safe and to determine what are the best doses to use. The second part will further refine this optimal dose. The third part continues to test the safety and how well GEN1119 works in additional participants with specific cancer types and at doses chosen based on the results of the first 2 parts of the trial. For each participant, the trial will last approximately 18 months but this may vary for each individual. This includes a Screening Period of up to 21 days before receiving trial treatment, an estimated 5 months of treatment (the duration of treatment may vary for each participant), and approximately 12.5 months of follow up after trial treatment ends (the duration of follow up may vary for each participant). Participation in the trial will require visits to the site, with more frequent visits during the first 6 weeks 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.
Eligibility Criteria
Key Inclusion Criteria: * Have histologically or cytologically confirmed diagnosis of protocol-specified solid tumours. * Have progressed on standard of care (SoC) therapy applicable for the tumor type, or for whom there is no available SoC therapy likely to provide clinical benefit, and for whom experimental therapy with GEN1119 may be a suitable option in the opinion of the investigator. * Have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. * Have acceptable laboratory test results before GEN1119 administration per protocol Key Exclusion Criteria: * Prior treatment with certain protocol-defined therapy. * Prior treatment with T-cell engagers, chimeric antigen receptor T-cell (CAR-T-cell) therapies, other protocol defined therapies, or other therapeutic moieties targeting certain protocol-defined molecules. * Treatment with an anticancer agent within 4 weeks or within 5 half lives of the drug, whichever is shorter, but not within 2 weeks before Cycle 1 Day 1 (C1D1). * Has clinically significant toxicities from previous anticancer therapies that have not resolved to baseline levels or to Grade 1 or lower, except for anorexia, hyperthyroidism, hypothyroidism, and peripheral neuropathy, which must have recovered to ≤ Grade 2. There is no limitation for alopecia from previous therapies. * Participant should not have active Hepatitis B infection. Participants with prior infections or chronic infections are allowed if monitored or treated as per local SOC and are negative for hepatitis B virus (HBV) DNA measured viral load. * Hepatitis C virus (HCV): Known active HCV infection (defined as positive for HCV ribonucleic acid \[RNA\] \[qualitative\]). Note: Other protocol-defined Inclusion and Exclusion criteria may apply.
Contact & Investigator
Study Official
STUDY DIRECTOR
Genmab
Frequently Asked Questions
Who can join the NCT07695831 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumours. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07695831 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07695831 currently recruiting?
Yes, NCT07695831 is actively recruiting participants. Contact the research team at clinicaltrials@genmab.com for enrollment information.
Where is the NCT07695831 trial being conducted?
This trial is being conducted at Rennes, France, Hirakata, Japan, Chuo Ku, Japan, Koto-Ku, Japan and 2 additional locations.
Who is sponsoring the NCT07695831 clinical trial?
NCT07695831 is sponsored by Genmab. The principal investigator is Study Official at Genmab. The trial plans to enroll 112 participants.