Study on CR-002 for Adults with Advanced or Metastatic Solid Tumors

Sponsor: Crescent Biopharma, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT07909031

Provider View

This clinical trial is testing a new treatment called CR-002 to see if it is safe and well-tolerated in adults with advanced or metastatic solid tumors. The study aims to find the best dose for future research.

Patient Parameters

Program Overview

The goal of this study is to evaluate the safety of a new treatment, CR-002, in adults with advanced or metastatic solid tumors. Researchers want to determine the most effective dose for future studies. Participants will receive the treatment and undergo various tests to monitor their health and response to the treatment.

Description

The study is divided into several parts. Initially, it will include two main phases: dose escalation and backfill. In the dose escalation phase, participants will receive increasing doses of CR-002 to find the safest and most effective dose. In the backfill phase, more participants will receive doses that have already been deemed safe.

All participants will go through a screening period to ensure they meet the study criteria. During the treatment period, they will have regular health checks, including scans and blood tests, to monitor their response to the treatment. After the treatment ends, participants will continue to have scans to check for disease progression and will have follow-up phone calls every three months to monitor their long-term health.

Eligibility Criteria

Inclusion Criteria

  • Life expectancy of at least 3 months.
  • Good overall health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Adequate organ function and blood cell counts based on lab tests.
  • Have measurable cancer that can be tracked using standard criteria.
  • Willing to provide a recent tumor sample or undergo a biopsy.
  • Have advanced or metastatic cancer that is not responding to standard treatments or cannot receive them, including:
    • Head and Neck Squamous Cell Carcinoma
    • Gastric/GEJ Cancer
    • Biliary Tract Cancer
    • Esophageal Squamous Cell Carcinoma
    • Ovarian Cancer
    • Endometrial Carcinoma
    • Cervical Cancer
    • Non-Small Cell Lung Cancer

Exclusion Criteria

  • Have had other cancers within the past 3 years, except for the cancer being studied.
  • Have not fully recovered from recent major surgery.
  • Have ongoing significant side effects from previous treatments.
  • Have known allergies to any part of CR-002.
  • Have received previous treatment with a similar type of drug.
  • Have active cancer that has spread to the brain or spinal cord.
  • Have any medical or psychological conditions that could interfere with the study or increase risk.

Locations

FACILITYZIPCITYSTATE
Clinical Study Site78758AustinTexas
Clinical Study Site75039DallasTexas
Clinical Study Site22031FairfaxVirginia

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