BH3120 for Solid Tumors

Recruiting at 13 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BH3120 for individuals with advanced solid tumors, which are cancers that don't form liquid tumors like leukemia. The study examines the safety and effectiveness of BH3120, both alone and in combination with another drug, pembrolizumab. It targets individuals whose cancer has spread or cannot be surgically removed and who lack standard treatment options. Ideal candidates have a solid tumor outside the brain, a specific protein marker (PD-L1 positive), and at least one tumor untreated by radiation. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that BH3120 is generally safer than similar drugs, resulting in fewer side effects for people so far.

When combined with pembrolizumab, this treatment remains in early testing stages. The goal is to improve outcomes for cancer patients. However, since this is its first test in humans, complete safety information is not yet available.

As a Phase 1 trial, the primary purpose is to assess the treatment's safety and the body's reaction to it. Until more information is gathered, it is important to understand that safety details are still being determined. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about BH3120 because it offers a fresh approach to treating solid tumors. Unlike traditional therapies that often target tumor growth directly, BH3120 works by modulating the immune system, potentially enhancing its ability to fight cancer. In combination with pembrolizumab, an established immunotherapy, BH3120 aims to boost the body's natural defenses even further. This dual strategy not only promises a new mechanism of action but also holds the potential for improved outcomes in patients who may not respond well to existing treatments.

What evidence suggests that this trial's treatments could be effective for solid tumors?

Research has shown that BH3120 targets two proteins, 4-1BB and PDL1, which are crucial in the immune system's fight against cancer. Early studies suggest that BH3120 enhances the ability of T-cells, a type of immune cell, to attack cancer cells more effectively. In this trial, some participants will receive BH3120 as monotherapy, while others will receive it in combination with pembrolizumab, a known cancer treatment. Preclinical studies indicated that BH3120 could improve T-cells' ability to kill cancer cells. Although human trial data is limited, these findings suggest it could be promising for treating solid tumors. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06234397?term=BH-BAFP-101&rank=1

Dose Escalation and Expansion Study of BH3120 Alone or ... 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 ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06234397/dose-escalation-and-expansion-study-of-bh3120-alone-or-with-pembrolizuamb-in-advanced-or-metastatic-solid-tumors

Dose Escalation and Expansion Study of BH3120 Alone or ... This is a First-in-Human, Phase 1, Dose-Escalation and Dose-Expansion study of BH3120, as a single agent and in combination with ...

3. biospace.com biospace.com/hanmi-enters-into-clinical-trial-collaboration-and-supply-agreement-with-msd-to-evaluate-bh3120-in-combination-with-keytruda-pembrolizumab

Hanmi Enters into Clinical Trial Collaboration and Supply ... He said, "Through the collaboration with MSD, we expect BH3120 in combination with KEYTRUDA could improve outcomes for patients with relapsed or ...

4. synapse.patsnap.com synapse.patsnap.com/blog/hanmi-pharmaceutical-and-beijing-hanmi-progress-bh3120-cancer-immunotherapy-trials

Beijing Hanmi Pharmaceutical BH3120 represents an innovative anticancer treatment developed using Hanmi's exclusive dual antibody technology known as Pentambody.

5. researchgate.net researchgate.net/publication/385556794_698_A_phase_I_open-label_multinational_multicenter_dose_escalation_and_expansion_study_of_BH3120_4-1BB_x_PD-L1_BsAb_in_patients_with_advanced_or_metastatic_solid_tumors

698 A phase I, open-label, multinational, multicenter, dose ... In preclinical studies, BH3120 promoted interaction between T-cells and tumor cells, forming a trimer, which efficiently enhanced cytotoxic ...

6. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-02547

Dose Escalation and Expansion Study of BH3120 Alone or ... 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, ...

7. clinicaltrialsarena.com clinicaltrialsarena.com/news/hanmi-clinical-trial-msd/

Hanmi signs clinical trial collaboration with MSD Hanmi will conduct a Phase I clinical trial to assess the safety and efficacy of BH3120 in combination with Keytruda (pembrolizumab), MSD's anti-PD-1 therapy.

8. prnewswire.com prnewswire.com/news-releases/hanmi-pharmaceutical-and-beijing-hanmi-progress-clinical-trials-of-co-developed-bh3120-as-a-next-generation-cancer-immunotherapy-302314945.html

Hanmi Pharmaceutical and Beijing ... Currently, a global Phase 1 clinical trial is underway in South Korea and the United States, assessing the safety and tolerability of BH3120 as ...