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Clinical Trials in the USA / NCT07909031
Recruiting Phase 1/2

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

NCT07909031 · tracked via the Priya Life Science USA tracker
Sponsor
Crescent Biopharma, Inc
Phase
Phase 1/2
Started
2026-10-21
Last updated
2026-11-02

Condition(s) studied

Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M)Gastric/GEJBiliary Tract Cancer (BTC)Esophageal Squamous Cell Carcinoma (ESCC)Ovarian CancerEndometrial CancerCervical Cancer MetastaticNon-small Cell Lung Cancer (NSCLC)

Investigational drug(s) / intervention(s)

CR-002

CR-002: Intravenous Infusion

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Part 1: Dose Escalation - incidence and nature of dose-limiting toxicities — From the first dose of study drug up until approximately 1 month
    Per cohort
  • Part 1: Dose Escalation - characterization of the maximum tolerated dose, if applicable — From the first dose of study drug up until approximately 1 month
    Per cohort
  • All Parts - incidence, nature, and severity of treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events — From the first dose of study drug until 90 days after the last dose of study drug
    Events are graded according to National Cancer Institute Cancer Terminology Criteria for Adverse Events (NCI CTCAE)
  • All Parts - incidence and severity of TEAEs leading to dose modifications — From the first dose of study drug until 90 days after the last dose of study drug
  • All Parts - incidence and severity of TEAEs leading to treatment discontinuation — From the first dose of study drug until 90 days after the last dose of study drug

Trial sites (3)

FacilityCityRegionStatus
Clinical Study Site Austin Texas Recruiting
Clinical Study Site Dallas Texas Recruiting
Clinical Study Site Fairfax Virginia Recruiting

More Crescent Biopharma, Inc. trials in the USA

CR-001 in Adult Participants With Locally Advanced or Metastatic Solid Tumors Recruiting

Other trials for the same condition

FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r/r Adenocarcinoma NSCLC Recruiting
D07001 Softgel-Capsules and Capecitabine Combination Therapy in Patients With Advanced Biliary Tract Cancer Recruiting
SKL35501 With SKL35502 Imaging in Adults With NTSR1 Positive Advanced Solid Tumors Recruiting
First in Human Study of TORL-1-23 in Participants With Advanced Cancer Recruiting
A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07909031 on ClinicalTrials.gov ↗ ← All trials in the USA