Clinical Trial of YH32367 in Patients With HER2 Positive Locally Advanced or Metastatic Solid Tumor

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-26

Study Completion Date

2026-12-01

Brief Summary

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This first-in-human study will be counducted to evaluate the safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of YH32367 in Patients with HER2-Positive Locally Advanced or Metastatic Solid Tumors.

Detailed Description

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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 signal activation as well as blocking of HER2 signaling in HER2-expressing tumor cells. YH32367 stimulates IFN-γ secretion from T cells and thereby induces tumor cells lysis.

This is a Phase 1/2, open-label, multicenter, first-in-human study of YH32367. This 2-part study will include both a Dose Escalation part, to identify the Maximum Tolerated Dose (MTD) and/or two dose levels for RP2D selection, and a Dose Expansion part, to determine RP2D and to confirm the safety, tolerability and efficacy of YH32367 at the RP2D.

Conditions

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HER2-Positive Solid Tumor

Keywords

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YH32367 HER2/4-1BB bispecific antibody Solid tumor Breast cancer Gastric cancer HER2-positive Biliary tract cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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YH32367

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).

Group Type EXPERIMENTAL

YH32367

Intervention Type DRUG

Dose Escalation Part: 8 Cohorts. In this part, approximately 30 patients will be enrolled and patients are assigned to receive YH32367 at a starting dose and the dose being escalated/de-escalated in adjacent dose cohorts will be up to Dose level 8.

Dose Expansion Part: 2 Cohorts(Cohort 1: Biliary tract cancer, Cohort 2: Solid tumors). The 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). Each cohort will enroll 65 and 40 patients, respectively.

Interventions

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YH32367

Dose Escalation Part: 8 Cohorts. In this part, approximately 30 patients will be enrolled and patients are assigned to receive YH32367 at a starting dose and the dose being escalated/de-escalated in adjacent dose cohorts will be up to Dose level 8.

Dose Expansion Part: 2 Cohorts(Cohort 1: Biliary tract cancer, Cohort 2: Solid tumors). The 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). Each cohort will enroll 65 and 40 patients, respectively.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\[Dose Escalation Part\]

* Pathologically confirmed HER2-positive
* Mandatory provision of tumor tissue sample

\[Dose Expansion Part\]

* Patients who have at least one measurable lesion
* Mandatory provision of tumor tissue sample

1. Cohort 1: Pathologically confirmed HER2-positive biliary tract cancer
2. Cohort 2: Pathologically confirmed HER2-positive metastatic solid tumor malignancy other than breast and gastric or gastroesophageal junction adenocarcinoma and biliary tract cancer

Exclusion Criteria

* Uncontrolled central nervous system (CNS) metastases
* Spinal cord compression
* Carcinomatous meningitis
* Acute coronary syndromes
* Heart failure
* Interstitial lung disease (ILD)
* Pneumonitis
* History of a second primary cancer
* Human immunodeficiency virus (HIV)
* Active chronic hepatitis B
* Hepatitis C
* Systemic steroid therapy
* Autoimmune disease

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

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Clinical Operation Team 1

Role: CONTACT

Phone: +82-2-828-0858

Email: [email protected]

Jiyong Park

Role: CONTACT

Phone: +82-2-828-0858

Email: [email protected]

Other Identifiers

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YH32367-101

Identifier Type: -

Identifier Source: org_study_id

Clinical Trial of YH32367 in Patients With HER2 Positive Locally Advanced or Metastatic Solid Tumor

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

YH32367

YH32367

Interventions

YH32367

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Yuhan Corporation

Responsible Party

Principal Investigators

Sun Young Rha

Kyu-pyo Kim

Do-Youn Oh

Joon Oh Park

Ganessan Kichenadasse

Jennifer Man

Arlene Chan

Ju Won Kim

Myung Ah Lee

Hongjae Chon

Niall Tebbutt

Jung Hun Kang

Seok Yun Kang

Hyung Soon Park

Ji Hong Bae

Cheol Kyung Sin

Hae Seong Park

Thatcher Heumman

Hongsik Kim

Locations

Dana Farber Cancer Institute

Vanderbilt Ingram Cancer Center

Southern Oncology Clinical Research Unit

Austin Health

Breast Cancer Research Centre - WA

Blacktown Hospital

CHA Bundang Medical Center

Catholic University of Korea St. Vincent's Hospital

Ajou University Hospital

Gyeongsang National University Hospital

Chungbuk National University Hospital

Gachon Gil University Medical Center

Korea University Anam Hospital

Seoul National University Hospital

Severance Hospital, Yonsei University Health System

Asan Medical Center

Samsung Medical Center

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

Ulsan University Hospital

Countries

Central Contacts

Clinical Operation Team 1

Jiyong Park

Other Identifiers

YH32367-101