HM16390 and Pembrolizumab for Advanced Solid Tumors

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.
Ready to participate?

Review the details below, then apply to join this clinical trial.

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
Who this trial is looking for

This trial is looking for adults with advanced or metastatic solid tumors who have not benefited from standard treatments. Participants will take the drug HM16390, either alone or with pembrolizumab, to assess its safety and effectiveness.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with an advanced or metastatic solid tumor.
  • I am at least 18 years old.
  • I have measurable disease as seen on imaging.
  • I have a good performance status (ECOG 0 or 1).
  • I have adequate kidney function.
  • I have adequate blood cell counts.
  • I have adequate liver function.
  • I have failed or cannot tolerate standard therapy.

You may not be able to join if

  • I have received prior treatment targeting IL-2, IL-7, or IL-15.
  • I have known active brain metastases or carcinomatous meningitis.
  • I have a history of severe side effects from immunotherapy.
  • I have unresolved significant side effects from previous treatments.
  • I have an ongoing or suspected autoimmune disease.
  • I have an active and significant infection.
  • I have a history of chronic liver disease or cirrhosis.
  • I am taking immunosuppressive medications.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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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

Hyebin Son

82-2-410-9835

hyebin.son@hanmi.co.kr

CONTACT