Recruiting
Phase 1
Phase 2

YH32367

Sponsor:

Yuhan Corporation

Code:

NCT05523947

Conditions

HER2-Positive Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

YH32367

Study Details

Brief summary:

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.

Conditions

HER2-Positive Solid Tumor

Study ID

NCT05523947

Start date

Aug 26, 2022

Status verified date

Jul, 2026

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

147 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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).

Interventions

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 approximately 75 and 40 patients, respectively.

Primary outcome measure

  • Treatment-emergent adverse events (TEAEs) up to Day 21 [ Time Frame: in dose escalation part, an average of 21 days ]
  • Objective Response Rate (ORR) [ Time Frame: through dose expansion part completion, approximately 2.5 year ]

Central Contacts and Locations

Central contacts

Clinical Operation Team 1

+82-2-828-0065clinicaltrials@yuhan.co.kr

Heayeon Yoo

+82-2-828-0065hy1221@yuhan.co.kr

Locations

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Vanderbilt Ingram Cancer Center

Recruiting

Nashville, Tennessee, United States, 37232

More Information

Sponsor

Yuhan Corporation

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yuhan Corporation on 2026-07-16.