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A Phase 1/2, Open-Label, Multi-Center, Dose Escalation and Expansion Study Evaluating the Safety, Tolerability and Clinical Activity of DECOY20 as Monotherapy and in Combination With Tislelizumab in Patients With Advanced Solid Tumors

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Trial Profile

A Phase 1/2, Open-Label, Multi-Center, Dose Escalation and Expansion Study Evaluating the Safety, Tolerability and Clinical Activity of DECOY20 as Monotherapy and in Combination With Tislelizumab in Patients With Advanced Solid Tumors

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 28 Oct 2025

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At a glance

  • Drugs Decoy 20 (Primary) ; Tislelizumab (Primary)
  • Indications Carcinoma; Head and neck cancer; Solid tumours; Squamous cell cancer
  • Focus Adverse reactions; First in man
  • Sponsors Indaptus Therapeutics

Most Recent Events

  • 04 Sep 2025 According to an Indaptus Therapeutics media release, the company provided updates on the ongoing INDP-D101 clinical trial. The monotherapy portion has been completed, and seven patients have been dosed in the initial safety cohort of combination therapy with tislelizumab. Dosing of additional patients in this cohort is ongoing, and the company looks forward to sharing initial combination trial data later this year, with results expected in the coming weeks.
  • 02 Jun 2025 According to an Indaptus Therapeutics media release, the first patient has been dosed in the expansion arm of its Phase 1b/2 clinical trial evaluating Decoy20 in combination with BeOne's (formerly known as Beigene) PD-1 checkpoint inhibitor, tislelizumab.
  • 14 May 2025 According to an Indaptus Therapeutics media release, to date, 32 patients have been enrolled, in the weekly dosing among the two Decoy20 dose levels and to conclude enrollment for this arm and move to the combination treatment of Decoy20 with Tislelizumab.

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