Trial Profile

A Phase 1/2, Open-label, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of Single and Multiple Doses of Oral Administration of HS-10365 in Patients With Locally Advanced or Metastatic Solid Tumors

Status: Recruiting

Phase of Trial: Phase I/II

Latest Information Update: 05 Jun 2023

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At a glance

Drugs HS 10365 (Primary)
Indications Carcinoma; Non-small cell lung cancer; Solid tumours; Thyroid cancer
Focus Adverse reactions; First in man; Therapeutic Use
Sponsors Jiangsu Hansoh Pharmaceutical

29 May 2023 Trial phase changed from Phase I to Phase I/II. Efficacy endpoint added to primary outcome measures. Planned number of patients also increased. Inclusion and exclusion criteria amended.
29 May 2023 Planned number of patients changed from 48 to 306.
29 May 2023 Planned End Date changed from 31 Dec 2023 to 31 Dec 2025.

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