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