Search / Trial NCT06234397

Dose Escalation and Expansion Study of BH3120 Alone or With Pembrolizuamb in Advanced or Metastatic Solid Tumors

Launched by HANMI PHARMACEUTICAL COMPANY LIMITED · Jan 29, 2024

Trial Information

Current as of October 09, 2024

Recruiting

Keywords

Description

No description provided

Gender

ALL

Eligibility criteria

  • Key Inclusion Criteria:
  • * Have a Histologically or cytologically confirmed non-CNS solid tumor that is metastatic or unresectable and for whom there is no available standard therapy.
  • * PD-L1 positive expression (Tumor Proportion Score ≥1% or Combined Positive Score ≥1).
  • * Have at least one lesion, not previously irradiated that can be accurately measured per RECIST version 1.1.
  • * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • * Age of 18 years or older (or country's legal age of majority if the legal age was \>18 years)
  • * Adequate Hematologic and liver function.
  • Key Exclusion Criteria:
  • * Has received prior therapy with an anti-4-1BB(CD137) agent.
  • * Known active CNS metastases and/or carcinomatous meningitis.
  • * Known additional malignancy that is progressing or has required active treatment.
  • * History of chronic liver disease or evidence of hepatic cirrhosis.
  • * History of severe toxicities associated with a prior immunotherapy.
  • * 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.

About Hanmi Pharmaceutical Company Limited

Hanmi Pharmaceutical Company Limited is a leading South Korean biopharmaceutical firm dedicated to the research, development, and commercialization of innovative therapeutic solutions. With a strong focus on addressing unmet medical needs, Hanmi leverages advanced technologies and a robust pipeline of drug candidates across various therapeutic areas, including oncology, diabetes, and autoimmune diseases. The company emphasizes collaboration and strategic partnerships to enhance its research capabilities and accelerate the development of novel treatments, positioning itself as a key player in the global healthcare landscape. Hanmi's commitment to quality, safety, and efficacy underpins its clinical trials, ensuring rigorous adherence to regulatory standards and contributing to the advancement of patient care worldwide.

Locations

Hackensack, New Jersey, United States

Seoul, , Korea, Republic Of

Seoul, , Korea, Republic Of

Seoul, , Korea, Republic Of

Seoul, , Korea, Republic Of

Seongnam Si, , Korea, Republic Of

Dallas, Texas, United States

Cincinnati, Ohio, United States

Seoul, Gwanak Gu, Korea, Republic Of

San Antonio, Texas, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0