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CR-002 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, and Antitumor Activity of CR-002 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * 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 * Willingness to provide recent archival tumor tissue sample or willingness to undergo biopsy * Tumor indication specific inclusion criteria: * Is 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: * Head and Neck Squamous Cell Carcinoma (HNSCC) * Gastric/GEJ Cancer * Biliary Tract Cancer (BTC) * Esophageal Squamous Cell Carcinoma (ESCC) * Ovarian Cancer * Endometrial Carcinoma * Cervical Cancer * Non-Small Cell Lung Cancer (NSCLC) Exclusion Criteria: * Has malignancies other than disease under study within the past 3 years * Has not adequately recovered from recent major surgery * Has ongoing clinically significant toxicity related to prior therapy * Has known sensitivity to any component of CR-002 * Has received prior treatment with an antibody-drug conjugate (ADC) with a topoisomerase I inhibitor payload. * Has active central nervous system (CNS) metastases * Has a medical or psychological condition that could interfere with study participation, increase risk, or affect interpretation of the study results * NOTE: Other protocol defined Inclusion and Exclusion criteria may apply.
About the study
The purpose of this study is to determine the safety and tolerability of monotherapy CR-002 and to identify the MTD and/or optimal biologic dose and RP2D(s) in participants with locally advanced or metastatic solid tumors.
What is being tested
- CR-002 (drug)
Sponsor: Crescent Biopharma, Inc. · Participants: 219 · Started: Oct 21, 2026
Contact the study team
- Crescent Clinical Trials · Phone: 617-430-5595
Official record on ClinicalTrials.gov — NCT07909031
Locations in the U.S.
| Texas | Clinical Study Site, Austin Clinical Study Site, Dallas |
| Virginia | Clinical Study Site, Fairfax |
Conditions
- Head and Neck Squamous Cell Carcinoma
- Metastatic Cancer
- Biliary Tract Cancer
- Esophageal Squamous Cell Carcinoma
- Ovarian Cancer
- Endometrial Cancer
- Non-Small Cell Lung Cancer
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.