Trial NCT06724016
Dose Escalation and Expansion Study of HM16390 Alone or With Pembrolizumab in Advanced or Metastatic Solid Tumors
- Phase
- Phase 1
- Sponsor
- Hanmi Pharmaceutical Company Limited
- Conditions
- Advanced or Metastatic Solid Tumors
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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.Performance status
* 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.Brain metastases
* 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.HIV
* History of chronic liver disease or evidence of hepatic cirrhosis.Hepatic
Restrictions found (4)
- Brain metastasesConditionalexclusionShow in the text
- HepaticOutrightexclusionShow in the text
- HIVOutrightexclusionShow in the text
- Performance statusOutrightinclusion
ECOG 0 or 1
Show in the text
Recruiting in Massachusetts
- Massachusetts General Hospital · Boston, Suffolk County