YH32367 for Advanced Cancers

Recruiting at 25 trial locations

Overseen By Jiyong Park

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Yuhan Corporation

Must not be taking: Systemic steroids

Disqualifiers: CNS metastases, Heart failure, ILD, others

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

Compensation: Varies

Number of Visits: Unknown

137 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called YH32367 for people with advanced HER2-positive cancers, a specific protein found in some cancers. The main goal is to determine if YH32367 is safe and effective in shrinking tumors. The trial has two parts: one to find the right dose and another to assess its effectiveness in specific cancers, such as biliary tract cancer or other solid tumors that aren't breast or stomach cancer. Eligible participants have HER2-positive cancers, have tried other treatments, and can provide a tumor sample. The study is not suitable for those with certain health conditions, such as heart problems or autoimmune diseases. As a Phase 1, Phase 2 trial, this research focuses on understanding how YH32367 works in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking cancer treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify if 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 YH32367 is likely to be safe for humans?

Research has shown that YH32367 underwent safety testing in earlier studies. These studies found that YH32367, a special antibody targeting certain proteins on cancer cells, was generally well-tolerated by patients. Importantly, doses up to 30 mg/kg proved safe.

Most participants did not experience severe side effects at these levels. While some had mild or moderate side effects, the studies did not report any unexpected or serious safety issues at these doses. This is encouraging for those considering participation in a trial with YH32367. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about YH32367 because it offers a novel approach for treating advanced cancers, particularly those that have become resistant to current therapies. Unlike standard treatments like gemcitabine and cisplatin, YH32367 is designed to target HER2-positive cancer cells, which are known for their aggressive growth and resistance to many conventional therapies. This targeted action could provide new hope for patients with biliary tract cancer and other solid tumors who have exhausted all other available options. By focusing on HER2-positive malignancies, YH32367 aims to deliver more effective and personalized treatment outcomes.

What evidence suggests that YH32367 might be an effective treatment for advanced cancers?

Research has shown that YH32367, the investigational treatment in this trial, offers two powerful effects. It targets HER2, a protein that can promote cancer growth, and h4-1BB, which enhances the immune system's ability to fight cancer. This combined approach may help the body combat cancer more effectively. Bispecific antibodies like YH32367 have shown promise in treating solid tumors by engaging both cancer cells and the immune system. Early results suggest this method could be effective, especially in cancers previously treated with other therapies. Although direct data on YH32367's effectiveness is limited, similar treatments using this approach have shown promise. ^{1 6 7 8 9}

Who Is on the Research Team?

Kyu-pyo Kim

Principal Investigator

Asan Medical Center

Joon Oh Park

Principal Investigator

Samsung Medical Center

Jung Hun Kang

Principal Investigator

Gyeongsang National University Hospital

Hongsik Kim

Principal Investigator

Chungbuk National University Hospital

Seok Yun Kang

Principal Investigator

Ajou University School of Medicine

Ji Hong Bae

Principal Investigator

Gachon Gil University Medical Center

Hae Seong Park

Principal Investigator

Dana-Farber Cancer Institute

Hyung Soon Park

Principal Investigator

Catholic University of Korea St. Vincent's Hospital

Thatcher Heumman

Principal Investigator

Vanderbilt-Ingram Cancer Center

Cheol Kyung Sin

Principal Investigator

Ulsan University Hospital

Arlene Chan

Principal Investigator

Breast Cancer Research Centre WA

Ju Won Kim

Principal Investigator

Korea University Anam Hospital

Ganessan Kichenadasse

Principal Investigator

Southern Oncology Clinical Research Unit

Myung Ah Lee

Principal Investigator

The Catholic University of Korea, St. Mary's hospital

Do-Youn Oh

Principal Investigator

Seoul National University Hospital

Jennifer Man

Principal Investigator

Blacktown Hospital

Niall Tebbutt

Principal Investigator

Austin Health

Sun Young Rha

Principal Investigator

Severance Hospital

Hongjae Chon

Principal Investigator

CHA Bundang Medical Center

Are You a Good Fit for This Trial?

This trial is for patients with HER2-positive advanced or metastatic solid tumors, such as breast, gastric, and biliary tract cancers. Participants must have a confirmed diagnosis and provide a tumor tissue sample. For the dose expansion part of the study, they need at least one measurable lesion.

Inclusion Criteria

I can provide a sample of my tumor for the study.

Patients who have at least one measurable lesion for Dose Expansion Part

I can provide a sample of my tumor for the study.

Exclusion Criteria

I have heart failure.

I have inflammation in my lungs.

I have spinal cord compression.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive YH32367 at escalating doses to identify the Maximum Tolerated Dose (MTD) and/or two dose levels for RP2D selection

21 days per cohort

Dose Expansion

Participants receive YH32367 at the RP2D to confirm safety, tolerability, and efficacy

up to 2.5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 3.5 years

What Are the Treatments Tested in This Trial?

Interventions

• YH32367

Trial Overview The trial is testing YH32367 to assess its safety, how well it's tolerated by patients, how the body processes it (pharmacokinetics), and its effectiveness in shrinking or controlling tumor growth in individuals with HER2-positive tumors.

How Is the Trial Designed?

Group I: YH32367 Experimental Treatment 1 Intervention

Dose Escalation Part: 8 Cohorts. In Dose Escalation part, patients are assigned to receive YH32367 at a starting dose and the dose being escalated/de-escalated in adjacent dose cohorts. Dose Expansion Part: 2 Cohorts (Cohort 1: Biliary tract cancer, Cohort 2: Solid tumors). Dose Expansion part will consist of multiple cohorts in patients who were treated with at least 1 prior gemcitabine- and/or cisplatin-based therapy, HER2 positive biliary tract cancer(Cohort 1); in patients who were treated with all available standard therapies and have no available options, HER2 positive solid tumor malignancies other than breast and gastric or gastroesophageal junction adenocarcinoma and biliary tract cancer(Cohort 2).

Who Is Running the Clinical Trial?

Yuhan Corporation

Lead Sponsor

Trials

111

Recruited

27,800+

Cho Wook-je

Yuhan Corporation

Chief Executive Officer since 2021

Bachelor's degree in Agricultural Chemistry from Korea University

Kim Yeol-hong

Yuhan Corporation

Chief Medical Officer since 2024

Not available

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05523947

Clinical Trial of YH32367 in Patients With HER2 Positive ... YH32367, a novel HER2/4-1BB bispecific antibody (BsAb), simultaneously targets HER2 and h4-1BB and binds to both targets. YH32367 exhibits a strong 4-1BB ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11329538/

Recent Advances in Immunotherapy for Advanced Biliary ... Biliary tract cancer (BTC) is a heterogeneous group of aggressive malignancies that arise from the epithelium of the biliary tract.

3. link.springer.com link.springer.com/article/10.1007/s40291-024-00734-w

Clinical Progresses and Challenges of Bispecific ... This review provides a comprehensive overview of the recent advances in the development and clinical application of BsAbs for the treatment of solid tumors.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38353044/

Clinical outcomes for previously treated patients with ... Across these studies, the objective tumor response rate was 6.9%, median overall survival was 6.6 months and median progression-free survival ...

5. jgo.amegroups.org jgo.amegroups.org/article/view/99507/html

Camrelizumab in combination with chemotherapy and ... The application of camrelizumab as neoadjuvant therapy in the treatment of patients with advanced BTC showed encouraging efficacy and safety.

6. aacrjournals.org aacrjournals.org/cancerres/article/85/8_Supplement_2/CT068/761697/Abstract-CT068-A-phase-1-2-open-label-multicenter

Abstract CT068: A phase 1/2, open-label, multicenter, first-in ... A phase 1/2, open-label, multicenter, first-in-human study to evaluate the safety, pharmacokinetics, and anti-tumor activity of YH32367 in ...

7. careacross.com careacross.com/clinical-trials/trial/NCT05523947

Clinical Trial of YH32367 in Patients With HER2 Positive ... Summary: This first-in-human study will be counducted to evaluate the safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of YH32367 in Patients ...

8. dana-farber.org dana-farber.org/clinical-trials/25-187

A Phase 1/2, Open-label, Multicenter, First-in-Human Study ... This first-in-human study will be counducted to evaluate the safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of YH32367 in Patients with ...

9. researchgate.net researchgate.net/publication/391189310_Abstract_CT068_A_phase_12_open-label_multicenter_first-in-human_study_to_evaluate_the_safety_pharmacokinetics_and_anti-tumor_activity_of_YH32367_in_patients_pts_with_HER2_locally_advancedmetastatic_am

Abstract CT068: A phase 1/2, open-label, multicenter, first- ... Conclusions YH32367, at doses ≤30 mg/kg, showed favorable safety, promising clinical benefit, and non-linear PK in previously treated pts with ...