Study on the Safety and Initial Effectiveness of GEN1055 for Treating Solid Tumors Alone and in Combination with Other Cancer Drugs

Sponsor: Genmab

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06391775

Provider View

This clinical trial is exploring the safety and early effectiveness of a new drug, GEN1055, used alone or with another cancer drug, pembrolizumab, and possibly chemotherapy, in treating certain types of cancer. Participants will receive active treatment, not a placebo.

Patient Parameters

Program Overview

The trial aims to understand how the drug GEN1055 works when used by itself and when combined with pembrolizumab, with or without chemotherapy, in treating certain cancers. Participants will receive one of these treatments and will not receive a placebo. The study has two parts: the first part focuses on finding safe doses of GEN1055, and the second part tests how well these doses work against cancer. Participants may receive treatment for up to 24 months, depending on their response and any side effects. Regular visits to the trial site will be required for monitoring and tests.

Description

This trial is conducted in multiple centers and has two phases: dose escalation and expansion.

In the Dose Escalation phase, researchers will determine the safest dose of GEN1055, both alone and with pembrolizumab, by observing any side effects in participants with advanced solid tumors.

In the Expansion phase, the study will further evaluate the safety and effectiveness of the chosen doses in more participants with specific types of cancer. This phase will also look at how the drug works in the body and its initial impact on tumors.

Participants will need to visit the trial site weekly for the first 12 weeks, then every three weeks, for tests and monitoring. The entire trial, including screening, treatment, and follow-up, will last about 39 months for each participant.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a measurable tumor based on specific medical criteria.
  • Provide scans from before the trial showing cancer progression after the last treatment.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Provide a tumor biopsy sample, preferably a fresh one taken during the screening period.

For Phase 1a and 1b (Dose Escalation):

  • Have confirmed advanced solid tumors that have spread or cannot be removed by surgery.
  • Have tried standard treatments, including platinum-based chemotherapy and anti-PD/PD-L1 therapies, if applicable, and have not responded, or have no other standard treatment options.

For Phase 2a (Expansion):

  • Additional criteria may apply based on specific cancer types.

Exclusion Criteria

  • Have uncontrolled illnesses, such as active infections needing IV treatment within 2 weeks before the trial.
  • Have significant heart problems, like severe heart failure or uncontrolled high blood pressure.
  • Have a history of severe immune-related side effects from previous treatments.
  • Have chronic liver disease or lung disease.
  • Have received certain treatments, like anticancer drugs or radiation, within specific timeframes before the trial.
  • Have active hepatitis B or C infections.
  • Other specific medical conditions or treatments may also exclude participation.

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