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
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.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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 Part, additional eligible subjects will be randomized 1:1 into each dose level. After a comprehensive review of available data from both Dose-Escalation Part and Dose-Ranging Part, the RDEs to be tested in the Dose-Expansion Part are determined. Dose-Expansion Part is designed to assess the potential efficacy of HM16390 as a single agent and in combination with pembrolizumab when administered at the RDEs to subjects in indication-specific expansion cohorts.
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…
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 patients for Dose-Ranging and Dose-Expansion Part must have at least one measurable lesion at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days before allocation or randomization.
* Age of 18 years or older (or country's legal age of majority if the legal age was \>18 years)
* Adequate renal function.
* Adequate hematologic function.
* Adequate liver function.
Key Exclusion Criteria:
* Received prior treatment with agent targeting the IL-2, IL-7, or IL-15 receptors, or related to mode of action of HM16390.
* Known active CNS metastases and/or carcinomatous meningitis.
* History of severe toxicities associated with a prior immunotherapy.
* Any prior treatment-related (i.e. chemotherapy, immunotherapy, radiotherapy) clinically significant toxicities that have not resolved to Grade ≤ 1 per NCI-CTCAE version 5.0 or prior treatment-related toxicities that are clinically unstable and clinically significant at time of enrollment.
* Has ongoing or suspected autoimmune disease.
* Known active and clinically significant bacterial, fungal or viral infection including known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, immunocompromised patients.
* History of chronic liver disease or evidence of hepatic cirrhosis.
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