Study to Evaluate CCS1477 in Advanced Tumors

Sponsor: CellCentric Ltd.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03568656

This clinical trial is testing a new drug, CCS1477, to see if it is safe and effective for patients with advanced cancers, including prostate, breast, lung, and other solid tumors.

Patient Parameters

Program Overview

The study is in its early phases and aims to understand how safe and tolerable CCS1477 is for patients with advanced cancers. It will also look at how the drug behaves in the body and its biological effects. The trial includes patients with metastatic castration-resistant prostate cancer, metastatic breast cancer, non-small cell lung cancer, or other advanced solid tumors.

Eligibility Criteria

Inclusion Criteria

  • Must provide consent to participate.
  • Be in good general health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have cancer that can be measured using scans or X-rays.
  • Have good organ function as determined by medical tests.
  • Use highly effective birth control during the study.

Additional criteria for prostate cancer patients:

  • Previously treated with specific prostate cancer drugs like abiraterone or enzalutamide, and possibly docetaxel.
  • Cancer must be progressing, shown by rising PSA levels, new bone lesions, or other criteria.
  • PSA level at screening must be 2 μg/L or higher.
  • Low testosterone levels (≤50 ng/dL).
  • Serum albumin level greater than 2.5 g/dL.

For patients in the CCS1477 plus abiraterone group:

  • Must have cancer that progressed on abiraterone.
  • If last abiraterone dose was over 6 months ago, a 4-week trial of abiraterone is needed to confirm it no longer works.

For patients in the CCS1477 plus enzalutamide group:

  • Must have cancer that progressed on enzalutamide.
  • If last enzalutamide dose was over 6 months ago, a 4-week trial of enzalutamide is needed to confirm it no longer works.

For patients in the mutation group:

  • Have advanced solid tumors with specific genetic markers that may respond to the treatment.

Exclusion Criteria

  • Have received chemotherapy or other cancer treatments within 14 days or 5 half-lives before starting the study.
  • Have had major surgery or significant injury within 4 weeks before starting the study.
  • Have taken certain medications that affect the liver enzyme CYP3A4 within 2 to 4 weeks before starting the study.
  • Have unresolved side effects from previous treatments that are more than mild.
  • Have severe or uncontrolled diseases or illnesses.
  • Have a prolonged QT interval on an ECG (>480 milliseconds).
  • Have primary brain tumors or known/suspected brain metastases.

Additional criteria for the CCS1477 plus abiraterone group:

  • Have significant heart problems.

Additional criteria for the CCS1477 plus enzalutamide group:

  • Have a history of seizures or factors that increase seizure risk.
  • Have taken certain medications that are metabolized by CYP2C9 or CYP2C19 within 2 weeks before starting the study.
  • Have significant heart problems.

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