Study on PRO1184 for Advanced Solid Tumors

Sponsor: Genmab

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05579366

Provider View

This clinical trial is testing the safety and effects of a new drug called PRO1184 in adults with advanced solid tumors that have spread or cannot be removed by surgery.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effects of PRO1184, a drug designed to target specific cancer cells, in adults with advanced solid tumors. These tumors include ovarian, endometrial, breast, non-small cell lung cancer, and mesothelioma. The study will explore different treatment approaches, including using PRO1184 alone or in combination with other therapies, to determine the best way to manage these cancers.

Description

This study is divided into four main parts:

  • Part A: This part will test different doses of PRO1184 to find the safest and most effective dose.
  • Part B: This part will focus on specific types of cancer to see how well PRO1184 works on its own.
  • Part C: This part will look at patients with ovarian cancer that has not responded to platinum-based treatments.
  • Part D: This part will test PRO1184 in combination with other drugs like carboplatin, bevacizumab, or pembrolizumab to see if these combinations are more effective.

Participants will continue receiving the study treatment until their cancer progresses, they experience unacceptable side effects, they choose to stop, or the study ends for other reasons.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced or metastatic solid tumors, including ovarian, endometrial, breast, non-small cell lung cancer, or mesothelioma.
  • Have previously received treatments that are known to be beneficial.
  • Be willing to provide a tumor sample for analysis.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have measurable disease according to specific criteria.
  • Have adequate blood, liver, kidney, and heart function.

For Part C:

  • Have high-grade serous ovarian cancer or related types.
  • Have received 1 to 3 lines of therapy and have platinum-resistant ovarian cancer.
  • Have received prior treatment with bevacizumab and, if applicable, a PARP inhibitor.
  • Have known FRα status and, if positive, have received specific prior treatment unless medically exempt.

For Part D:

  • Cohort D1: Have platinum-sensitive ovarian cancer and received 1 to 3 prior therapies.
  • Cohort D2: Have platinum-resistant ovarian cancer and received 1 to 2 prior therapies.
  • Cohort D3: Have endometrial cancer and received prior platinum-based chemotherapy.

Exclusion Criteria

  • Have had another type of cancer within the last 3 years.
  • Have active cancer spread to the brain or spinal cord, unless treated and stable.
  • Have an uncontrolled severe infection within the last 2 weeks.
  • Test positive for hepatitis B, hepatitis C, or HIV.
  • Have a history of lung disease requiring steroids in the past 2 years or current lung issues.
  • Have used certain medications that affect the liver within 14 days (for dose escalation only).
  • Have had prior treatment with a specific type of cancer drug.

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