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

Launched by GENMAB · Nov 11, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called GEN1286 for patients with advanced solid tumors, which are types of cancer that have spread and cannot be easily removed with surgery. The trial aims to determine how safe this treatment is, how well it works in fighting tumors, and how the body processes the drug. The study is divided into two parts: the first part will look at different doses of the treatment to find the best one, while the second part will focus on specific types of tumors and fine-tune the dose.

To be eligible for this trial, participants need to have a confirmed diagnosis of an advanced solid tumor that has either spread to other parts of the body or cannot be treated with local therapies. They should have already tried other treatments that have been shown to help, unless they could not receive them. Participants should also be generally healthy, with only mild side effects from previous cancer treatments. This trial is currently recruiting patients, and anyone interested should talk to their doctor to see if they qualify. Participants will receive the treatment and be closely monitored for both side effects and how well the treatment is working.

Gender

ALL

Eligibility criteria

• Key Inclusion 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).
• Key Exclusion Criteria:
• • Prior treatment with topoisomerase 1-based antibody-drug conjugate (ADC) therapy.
• • Note: Other protocol-defined inclusion and exclusion criteria may apply.