CR-001 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
A Phase 1/2, Multicenter, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of CR-001 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Crescent Biopharma, Inc.
290 participants
Feb 17, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria14
- Life expectancy ≥ 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1
- Adequate organ function and hematologic reserve based on laboratory parameters
- Have measurable disease defined by RECIST v1.1
- For Backfill and Dose Optimization: Willingness to provide recent archival tumor tissue sample or willingness to undergo biopsy
- For dose escalation or backfill: progressing from, intolerant to, or ineligible for (due to unavailability or contraindication) local standard of care therapies and have 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
- Non-small cell lung cancer
Exclusion Criteria12
- Has malignancies other than disease under study within the past 3 years
- Has conditions requiring treatment with clinically significant or increasing doses of systemic steroid therapy
- Has not adequately recovered from recent major surgery
- Has ongoing clinically significant toxicity related to prior therapy
- Has active central nervous system (CNS) metastases
- Has active autoimmune disease requiring systemic therapy in the past 2 years (replacement therapy is permitted)
- Has a history of serious Grade ≥ 3 immune-related adverse event (irAE)
- Has a history of noninfectious pneumonitis/interstitial lung disease
- Has an active severe infection
- Has received a live or attenuated vaccine within 30 days of the first dose
- Has undergone prior allogeneic stem cell or solid organ transplantation
- Has protocol-specified events related to gastrointestinal perforation, surgery, wound healing complications, and bleeding
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Interventions
Intravenous Infusion
Locations(9)
View Full Details on ClinicalTrials.gov
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NCT07335497