Study on CR-001 for Adults with Advanced or Metastatic Solid Tumors
Sponsor: Crescent Biopharma, Inc.
ClinicalTrials ID:NCT07335497
This clinical trial is testing a new treatment called CR-001 to find out if it is safe and well-tolerated in adults with advanced or metastatic solid tumors. The study aims to determine the best dose for future research.
Patient Parameters
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Program Overview
The goal of this study is to evaluate the safety of a new treatment called CR-001 in adults with advanced or metastatic solid tumors. Researchers want to find the highest dose that can be given safely and the best dose for future studies. Participants will receive CR-001 and undergo various tests to monitor their health and response to the treatment.
Description
The study is divided into three parts: dose escalation, backfill, and dose optimization. It starts with gradually increasing the dose of CR-001 in participants with certain advanced solid tumors to find the safest dose. More participants will join at safe dose levels in the backfill part. In dose optimization, participants will be randomly assigned to one of two CR-001 dose levels.
Participants will go through a screening period, a treatment period lasting up to 2 years, a safety follow-up period, and long-term follow-up for effectiveness and survival. During treatment, participants will have regular health checks, including scans and blood tests. After treatment, scans will continue until the disease progresses, and follow-up visits will be conducted by phone every 3 months.
Eligibility Criteria
Inclusion Criteria
- Have advanced or metastatic tumors that have not responded to, cannot tolerate, or are not eligible for standard treatments, including:
- Liver cancer
- Biliary tract cancer
- Endometrial cancer
- Cervical cancer
- Ovarian cancer
- Stomach or gastroesophageal cancer
- Colorectal cancer
- Non-small cell lung cancer
Exclusion Criteria
- Have had other cancers within the past 3 years.
- Need treatment with significant or increasing doses of steroids.
- Have not fully recovered from recent major surgery.
- Have ongoing significant side effects from previous treatments.
- Have active cancer spread to the brain or spinal cord.
- Have active autoimmune diseases needing treatment in the past 2 years (except for replacement therapy).
- Have a history of severe immune-related side effects.
- Have a history of lung inflammation or disease.
- Have a severe active infection.
- Have received a live vaccine within 30 days before the first dose.
- Have had a stem cell or organ transplant.
- Have specific issues related to gastrointestinal perforation, surgery, wound healing, and bleeding.
- Have significant heart disease.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Clinical Study Site | 80218 | Denver | Colorado |
| Clinical Study Site | 32827 | Orlando | Florida |
| Clinical Study Site | 34236 | Sarasota | Florida |
| Clinical Study Site | 49546 | Grand Rapids | Michigan |
| Clinical Study Site | 43210 | Columbus | Ohio |
| Clinical Study Site | 37203 | Nashville | Tennessee |
| Clinical Study Site | 75230 | Dallas | Texas |
| Clinical Study Site | 78229 | San Antonio | Texas |
| Clinical Study Site | 84119 | West Valley City | Utah |
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