BH3120 for Solid Tumors

Recruiting at 8 trial locations

Overseen By Young Su (Bobby) Noh

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Hanmi Pharmaceutical Company Limited

Disqualifiers: CNS metastases, Autoimmune disease, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

245 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a First-in-Human, Phase 1, Dose-Escalation and Dose-Expansion study of BH3120, 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 RD for Dose-Expansion part, while Dose-Expansion part is designed to assess potential efficacy of BH3120, as a single agent and in combination with pembrolizumab, when administered at the RD to subjects in indication-specific expansion cohorts.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Eligibility Criteria

This trial is for individuals with advanced or metastatic solid tumors. Participants must meet specific health criteria, which are not detailed here.

Inclusion Criteria

I have a measurable tumor that has not been treated with radiation.

I am fully active or restricted in physically strenuous activity but can do light work.

My cancer has spread, cannot be surgically removed, and there's no standard treatment for it.

Exclusion Criteria

I have had severe side effects from previous immunotherapy.

I do not have brain cancer, uncontrolled seizures, spinal cord compression, or cancer in the lining of my brain.

I have been treated with a drug targeting the 4-1BB protein.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-Escalation

Establish the maximum tolerated dose (MTD) or recommended dose (RD) for the Dose-Expansion part

21 days per cycle

Visits at the end of each cycle

Dose-Expansion

Assess potential efficacy of BH3120, as a single agent and in combination with pembrolizumab, when administered at the RD

Up to 2-3 years

Regular visits throughout the study

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days after the last treatment

Treatment Details

Interventions

• BH3120

Trial Overview The study tests BH3120 to find the safest and most effective dose for treating solid tumors. It has two parts: finding the maximum tolerated dose (MTD) and then testing that dose in more patients to see how well it works.

Participant Groups

Group I: BH3120 + pembrolizumab Experimental Treatment 2 Interventions

Arm B: BH3120 in combination with pembrolizumab

Group II: BH3120 Experimental Treatment 1 Intervention

Arm A: BH3120 Monotherapy

Who Is Running the Clinical Trial?

Hanmi Pharmaceutical Company Limited

Lead Sponsor

Trials

196

Recruited

62,100+

Young Choi

Hanmi Pharmaceutical Company Limited

Chief Medical Officer since 2023

PhD in Pharmacology from Yonsei University

Jae-Hyun Park

Hanmi Pharmaceutical Company Limited

Chief Executive Officer since 2024

MD from Seoul National University

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University