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A Phase 1 Dose-Escalation Study to Investigate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamic Activity of CLN-619 (Anti-MICA/MICB Antibody) Alone and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors

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Trial Profile

A Phase 1 Dose-Escalation Study to Investigate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamic Activity of CLN-619 (Anti-MICA/MICB Antibody) Alone and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 14 Aug 2025

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At a glance

  • Drugs CLN-619 (Primary) ; Datopotamab deruxtecan (Primary) ; Pembrolizumab (Primary) ; Carboplatin; Paclitaxel; Pemetrexed
  • Indications Advanced breast cancer; Carcinoma; Cervical cancer; Colorectal cancer; Endometrial cancer; Fallopian tube cancer; Gastric cancer; Gastrointestinal cancer; Head and neck cancer; Non-small cell lung cancer; Oesophageal cancer; Ovarian cancer; Parotid cancer; Peritoneal cancer; Salivary gland cancer; Solid tumours; Squamous cell cancer; Urogenital cancer
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Cullinan Therapeutics

Most Recent Events

  • 31 Jul 2025 The protocol has been amended to include Module C, D and E in patients with select tumor types receiving CLN-619 in combination with chemotherapy or Datopotamab deruxtecan. Hence the treatment arms, drugs and inclusion criteria have been updated.
  • 31 Jul 2025 Planned number of patients changed from 410 to 440.
  • 27 Feb 2025 According to Cullinan Therapeutics media release, The Company continues enrollment of disease-specific expansion cohorts of its Phase 1 study also it remains on track to report initial data for endometrial and cervical cancers in the second quarter of 2025.

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