Study on GEN1047 for Treating Solid Tumors - First Human Trial

Sponsor: Genmab

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05180474

Provider View

This clinical trial is testing a new drug, GEN1047, to see how it affects the body, its side effects, and how well it works against solid tumors. All participants will receive the active drug, and the study will last about 8 months for each person.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effects of a new drug, GEN1047, in people with solid tumors. Researchers want to understand the side effects, how the body processes the drug, and how effective it is in treating tumors. Participants will be involved in the study for about 8 months, which includes a 28-day screening period, around 3 months of treatment, and about 4 months of follow-up. Everyone in the study will receive the actual drug, not a placebo.

Description

This trial is an open-label study, meaning both the researchers and participants know what treatment is being given. It takes place at multiple centers and is divided into two parts: the dose escalation part (Phase 1) and the expansion part (Phase 2a). The first part aims to determine if GEN1047 is safe and to find the best dose for people with specific solid tumors. In the second part, up to two doses of GEN1047 will be tested further.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of a solid tumor, such as breast, endometrial, ovarian cancer, or non-small cell lung cancer, for which no standard treatment is available or suitable.
  • For ovarian cancer, the disease must have progressed after the last treatment and within 60 days of screening.
  • Must be at least 18 years old or the legal age of consent.
  • Must have experienced recurrence or progression after standard treatments or be unable to tolerate them.
  • Must have at least one measurable tumor that can be tracked using standard criteria.
  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Must provide a tumor tissue sample during screening.
  • Must provide all CT scans of tumors since the last treatment failure.

Exclusion Criteria

  • Significant heart problems within 6 months before starting the trial.
  • New or worsening brain tumors or spinal cord compression.
  • Previous treatment with drugs targeting CD3 and/or B7H4 or cell-based therapies.
  • Current or past lung inflammation (pneumonitis) that required steroids, including any ongoing lung changes seen in scans.

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