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

RecruitingPhase 1/2

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

Sponsor: Crescent Biopharma, Inc. · Participants: 219 · Started: Oct 21, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07909031

Locations in the U.S.

TexasClinical Study Site, Austin
Clinical Study Site, Dallas
VirginiaClinical Study Site, Fairfax

Conditions

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.