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Phase 1/2 study evaluating CLD-201 in patients with advanced metastatic solid tumors, including triple-negative breast cancer, unresectable melanoma, and squamous cell head and neck carcinoma

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Trial Profile

Phase 1/2 study evaluating CLD-201 in patients with advanced metastatic solid tumors, including triple-negative breast cancer, unresectable melanoma, and squamous cell head and neck carcinoma

Status: Planning
Phase of Trial: Phase I/II

Latest Information Update: 23 Apr 2025

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At a glance

  • Drugs SNV 1 (Primary)
  • Indications Carcinoma; Head and neck cancer; Malignant melanoma; Soft tissue sarcoma; Solid tumours; Squamous cell cancer; Triple negative breast cancer
  • Focus Adverse reactions; First in man
  • Sponsors Calidi Biotherapeutics

Most Recent Events

  • 17 Apr 2025 According to Calidi Biotherapeutics media release, the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CLD-201
  • 31 Mar 2025 According to Calidi Biotherapeutics media release, company filed IND in March 2025 for CLD-201 company sponsored Phase 1 trial to treat multiple solid tumors.
  • 18 Jul 2024 According to Calidi Biotherapeutics media release, company look forward to submitting an IND to initiate this first-in-human clinical trial of this off-the-shelf allogeneic therapy, as continue building the understanding of the safety and effectiveness of CLD-201 in patients with advanced solid tumors.

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