Actively Recruiting
CR-001 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Led by Crescent Biopharma, Inc. · Updated on 2026-05-06
290
Participants Needed
10
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to determine the safety and tolerability of monotherapy CR-001 and identify the maximum tolerated dose (MTD), and/or optimal biologic dose and Recommended Phase 2 Dose(s) (RP2D) in participants with locally advanced or metastatic solid tumors.
CONDITIONS
Official Title
CR-001 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Life expectancy of at least 3 months
- ECOG performance status score of 0 or 1
- Adequate organ function and blood counts based on lab tests
- Measurable disease according to RECIST v1.1
- Willing to provide recent tumor tissue sample or undergo biopsy for backfill and dose optimization parts
- For dose escalation or backfill: progressing from, intolerant to, or ineligible for local standard therapies
- Diagnosed with one of the following locally advanced or metastatic tumor types: hepatocellular carcinoma, biliary tract cancer, endometrial carcinoma, cervical cancer, ovarian cancer, gastric or gastroesophageal cancer, colorectal cancer, or non-small cell lung cancer
You will not qualify if you...
- History of other cancers within the past 3 years
- Need for treatment with significant or increasing doses of systemic steroids
- Not recovered adequately from recent major surgery
- Ongoing significant toxicity from previous therapy
- Active metastases in the central nervous system
- Active autoimmune disease requiring systemic treatment in the past 2 years (replacement therapy allowed)
- History of serious immune-related adverse events graded 3 or higher
- History of noninfectious pneumonitis or interstitial lung disease
- Active severe infection
- Received a live or attenuated vaccine within 30 days before first dose
- Previous allogeneic stem cell or solid organ transplant
- Recent gastrointestinal perforation, surgery, wound healing problems, or bleeding events specified by the protocol
- Clinically significant cardiovascular disease
- Other protocol-defined exclusion criteria may apply
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Clinical Study Site
Denver, Colorado, United States, 80218
Actively Recruiting
2
Clinical Study Site
Orlando, Florida, United States, 32827
Actively Recruiting
3
Clinical Study Site
Sarasota, Florida, United States, 34236
Actively Recruiting
4
Clinical Study Site
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
5
Clinical Study Site
Columbus, Ohio, United States, 43210
Actively Recruiting
6
Clinical Study Site
Nashville, Tennessee, United States, 37203
Actively Recruiting
7
Clinical Study Site
Dallas, Texas, United States, 75230
Actively Recruiting
8
Clinical Study Site
San Antonio, Texas, United States, 78229
Actively Recruiting
9
Clinical Study Site
West Valley City, Utah, United States, 84119
Actively Recruiting
10
Clinical Study Site
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
Research Team
C
Crescent Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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