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CR-001 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, Pharmacodynamics, and Antitumor Activity of CR-001 in Adult Participants With Locally Advanced or Metastatic Solid Tumors

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Key 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
* For Backfill and Dose Optimization: Willingness to provide recent archival tumor tissue sample or willingness to undergo biopsy
* Tumor Indication specific inclusion criteria:
* For dose escalation or backfill: 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:

  * Hepatocellular carcinoma
  * Biliary tract cancer
  * Endometrial carcinoma
  * Cervical cancer
  * Ovarian cancer
  * Gastric or gastroesophageal cancer
  * Colorectal cancer
  * Non-small cell lung cancer

Key Exclusion Criteria

* Has malignancies other than disease under study within the past 3 years
* Has conditions requiring treatment with clinically significant or increasing doses of systemic steroid therapy
* Has not adequately recovered from recent major surgery
* Has ongoing clinically significant toxicity related to prior therapy
* Has active central nervous system (CNS) metastases
* Has active autoimmune disease requiring systemic therapy in the past 2 years (replacement therapy is permitted)
* Has a history of serious Grade ≥ 3 immune-related adverse event (irAE)
* Has a history of noninfectious pneumonitis/interstitial lung disease
* Has an active severe infection
* Has received a live or attenuated vaccine within 30 days of the first dose
* Has undergone prior allogeneic stem cell or solid organ transplantation
* Has protocol-specified events related to gastrointestinal perforation, surgery, wound healing complications, and bleeding
* Has clinically significant cardiovascular disease 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-001 and identify the maximum tolerated dose (MTD), and/or optimal biologic dose and Recommended Phase 2 Dose(s) (RP2D) in participants with locally advanced or metastatic solid tumors.

What is being tested

Sponsor: Crescent Biopharma, Inc. · Participants: 290 · Started: Feb 17, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07335497

Locations in the U.S.

AlabamaClinical Study Site, Birmingham
CaliforniaClinical Study Site, Los Angeles
ColoradoClinical Study Site, Denver
District of ColumbiaClinical Study Site, Washington D.C.
FloridaClinical Study Site, Orlando
Clinical Study Site, Sarasota
MichiganClinical Study Site, Detroit
Clinical Study Site, Grand Rapids
New YorkClinical Study Site, New York
OhioClinical Study Site, Columbus
PennsylvaniaClinical Study Site, Pittsburgh
TennesseeClinical Study Site, Nashville
TexasClinical Study Site, Dallas
Clinical Study Site, San Antonio
UtahClinical Study Site, West Valley City

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.