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Recruiting NCT07909031

CR-002 in Adult Participants With Locally Advanced or Metastatic Solid Tumors

Conditions: Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M), Gastric/GEJ, Biliary Tract Cancer (BTC), Esophageal Squamous Cell Carcinoma (ESCC), Ovarian Cancer, Endometrial Cancer, Cervical Cancer Metastatic, Non-small Cell Lung Cancer (NSCLC)

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 219
Sponsor: Crescent Biopharma, Inc.

Location: Clinical Study Site Austin Texas

Summary

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.

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07909031). StuddyBuddy aggregates publicly available trial information.