Study on Dazostinag Alone and with Pembrolizumab for Adults with Advanced or Metastatic Solid Tumors

Sponsor: Takeda

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04420884

Provider View

This clinical trial is testing the safety and appropriate dosage of a new drug, dazostinag, both alone and in combination with pembrolizumab, for treating adults with advanced solid tumors. The study will explore how well these treatments work, especially in specific types of head and neck cancer and colorectal cancer.

Patient Parameters

Program Overview

The main goal of this study is to determine if dazostinag, a new drug, is safe and what dose can be given without causing significant side effects. The study will test dazostinag alone and with pembrolizumab, a drug that helps the immune system fight cancer. The study has two phases: a dose escalation phase to find the right dose, and a dose expansion phase to test the treatment in specific cancers, including head and neck cancer and colorectal cancer.

Description

This study is testing a new drug called dazostinag for people with advanced or metastatic solid tumors. The study will include about 374 participants and is divided into different parts:

  • Part 1 (Dose Escalation Phase): This part will test increasing doses of dazostinag alone and with pembrolizumab to find a safe dose.
  • Part 2 (Expansion Phase for Head and Neck Cancer): This part will test dazostinag with pembrolizumab, with or without chemotherapy, in people with untreated metastatic or recurrent head and neck cancer.
  • Part 3 (Expansion Phase for Colorectal Cancer): This part will test dazostinag with pembrolizumab in people with specific types of colorectal cancer that have not responded to other treatments.

Participants will visit the clinic multiple times, including a follow-up visit 30 days after the last dose. The study will last about 62.9 months, and participants in Parts 2 and 3 will be followed for up to 12 months after the last dose to check on their survival.

Eligibility Criteria

Inclusion Criteria

  • Adults with advanced or metastatic solid tumors that have no standard treatment options.
  • Good overall health with an ECOG performance status of 0 or 1.
  • For head and neck cancer: Must not have had prior systemic therapy for recurrent or metastatic cancer.
  • For colorectal cancer: Must have specific genetic markers (MSI-H/dMMR or MSS/pMMR) and have tried other treatments without success.
  • Must have adequate organ function and a heart function of more than 50%.
  • Must have at least one measurable tumor.
  • Must agree to provide tumor samples for testing.

Exclusion Criteria

  • Heart rhythm issues or low blood pressure.
  • Low oxygen levels.
  • Recent use of certain immune system drugs.
  • Lung diseases or infections.
  • Brain metastases unless stable and treated.
  • Active hepatitis or other infections.
  • Recent cancer treatments or other serious health conditions.
  • Pregnant or breastfeeding women.
  • Previous treatment with similar drugs or therapies.

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