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OncoMatch/Clinical Trials/NCT07335497

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

Official title: 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

Is NCT07335497 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1/2 trial studies multiple treatments for locally advanced / metastatic solid tumors.

Phase 1/2RecruitingCrescent Biopharma, Inc.NCT07335497Data as of Oct 2026Location: International · 9 countries

Treatment: CR-001 · Paclitaxel · trifluridine and tipiracil · Pemetrexed · Carboplatin · Oxaliplatin · Gemcitabin · Cisplatin · Capecitabine · FOLFOX — 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.

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Extracted eligibility criteria

Treatments studied

Chemotherapy

PaclitaxelPemetrexedCarboplatinOxaliplatinCisplatinCapecitabine

Other

CR-001trifluridine and tipiracilGemcitabinFOLFOX

Cancer type

Tumor Agnostic

Non-Small Cell Lung Carcinoma

Hepatocellular Carcinoma

Cholangiocarcinoma

Endometrial Cancer

Cervical Cancer

Ovarian Cancer

Gastric Cancer

Colorectal Cancer

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: anti-PD-1/PD-L1 therapy

Has received prior anti-PD-1/L1 treatment

Cannot have received: allogeneic stem cell transplant

Has undergone prior allogeneic stem cell or solid organ transplantation

Lab requirements

Blood counts

Kidney function

Liver function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Clinical Study Site · Birmingham, Alabama
  • Clinical Study Site · Los Angeles, California
  • Clinical Study Site · Denver, Colorado
  • Clinical Study Site · Washington D.C., District of Columbia
  • Clinical Study Site · Orlando, Florida

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT07335497 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior anti-PD-1/PD-L1 therapy, allogeneic stem cell transplant disqualifies patients from enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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