Study of BDC-3042 Alone and with Cemiplimab in Patients with Advanced Cancers

Sponsor: Bolt Biotherapeutics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06052852

Provider View

This clinical trial is testing a new drug, BDC-3042, both by itself and in combination with another drug, cemiplimab, to see if it is safe and effective for treating advanced cancers.

Patient Parameters

Program Overview

This study is the first to test BDC-3042 in humans. It aims to find the safest dose of BDC-3042 when used alone and when combined with cemiplimab, a drug used to treat cancer. The study is divided into four parts. In the first part, researchers will gradually increase the dose of BDC-3042 to find the highest dose that patients can tolerate. In the second part, they will do the same with BDC-3042 combined with cemiplimab. In the third and fourth parts, the best dose found will be given to patients with specific advanced cancers to see how well it works.

Description

This study involves four main parts:

  1. Part 1: Researchers will test different doses of BDC-3042 alone to find the highest dose that patients can safely tolerate. This will help determine the best dose to use in later parts of the study.

  2. Part 2: Similar to Part 1, but BDC-3042 will be combined with cemiplimab. The goal is to find the safest dose of this combination.

  3. Part 3: Patients with certain advanced cancers will receive the best dose of BDC-3042 found in Part 1 to see how well it works.

  4. Part 4: Patients will receive the best dose of the BDC-3042 and cemiplimab combination found in Part 2 to evaluate its effectiveness.

The study will include patients who have advanced cancers that have not responded to standard treatments. Participants will need to meet specific health criteria to join the study, such as having good organ function and a life expectancy of more than 12 weeks. Women who can become pregnant must use effective birth control during the study and for four months after treatment ends. Men must also use birth control methods to prevent pregnancy during the study and for four months after.

Eligibility Criteria

Inclusion Criteria

  • Able to understand and sign a consent form.
  • Aged 18 years or older.
  • Have cancer that can be measured by scans.
  • In good general health, able to carry out normal activities or light work.
  • For Parts 1 and 2: Have specific types of advanced cancer that have not responded to standard treatments.
  • For Parts 3 and 4: Have advanced cancer that has not responded to standard treatments.
  • Have good organ function, including:
    • Adequate blood cell counts.
    • Good kidney function.
    • Normal blood clotting times.
    • Liver enzymes and bilirubin within specified limits.
  • Expected to live more than 12 weeks.
  • Women of childbearing potential must use effective birth control during and after treatment.
  • Men must use condoms and another form of birth control during and after treatment.

Exclusion Criteria

  • Have an active yeast infection within four weeks before starting the study.
  • Have been hospitalized for asthma in the past year.
  • Have cancer that has spread to the brain unless it is stable and not requiring steroids.
  • Have serious heart conditions, such as heart failure or recent heart attack.
  • Have serious lung conditions, like severe asthma or COPD.
  • Have serious liver disease.
  • Have had a stroke or similar event in the past six months.
  • Have a bleeding disorder or recent significant bleeding.
  • Have had a bone marrow or organ transplant.
  • Have active infections, including COVID-19, HIV, hepatitis B, or hepatitis C.
  • Have an autoimmune disease requiring treatment in the past two years.
  • Have had another cancer in the past two years, except for certain non-threatening cancers.
  • Require high doses of steroids or other immune-suppressing drugs.
  • Have unresolved side effects from previous treatments.
  • Have allergies to study drugs.
  • Have received another investigational drug recently.
  • Have had major surgery recently.
  • Are pregnant or breastfeeding.
  • Are unable to follow study requirements.
  • Have a bowel perforation or fistula.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.