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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

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Trial Profile

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

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 15 Sep 2026

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At a glance

  • Drugs CR-001-Crescent Biopharma (Primary)
  • Indications Gastrointestinal cancer; Gynaecological cancer; Non-small cell lung cancer; Solid tumours
  • Focus Adverse reactions; First in man; Proof of concept
  • Acronyms ASCEND
  • Sponsors Crescent Biopharma

Most Recent Events

  • 15 Jun 2026 Planned number of patients changed from 410 to 490.
  • 22 May 2026 According to Crescent Biopharma Media Release, Initial data of CR-001 in combination with standard of care chemotherapy in first-line and previously treated patients in mid-2027 (Q2/Q3) utilizing the dose expansion part of the ASCEND trial.
  • 22 May 2026 According to Crescent Biopharma Media Release, A backfill cohort of first-line NSCLC patients is planned as part of this readout.

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