Dose Escalation and Expansion Study of HM16390 Alone or With Pembrolizumab in Advanced or Metastatic Solid Tumors

Recruiting Phase 1 Interventional Study
Advanced or Metastatic Solid Tumors
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
292 (estimated)
Sponsor
Hanmi Pharmaceutical Company Limited · Industry
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About This Trial
This is a First-in-Human, Phase 1, Dose-Escalation and Dose-Expansion study of HM16390, as a single agent and in combination with pembrolizumab to assess safety, tolerability, MTD, RP2D, PK, and efficacy in patients with advanced or metastatic solid tumors. Dose-Escalation Part is planned to establish the MTD or RDs for the randomized Dose-Ranging Part. Based on the results of the Dose-Escalation…
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria: * Have a histologically and/or cytologically confirmed advanced or metastatic solid tumor and have failed or are intolerant to standard therapy with clinical benefit. * Patients in the Dose-Escalation Part must have evaluable or measurable disease at baseline and the patient…
Contacts

Young Su (Bobby) Noh

82-2-410-9277

63forever@hanmi.co.kr

CONTACT