Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05523947

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

HER2-positive Solid Tumor Biliary Tract Diseases Biliary Tract Neoplasms Breast Diseases Breast Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Southern Oncology Clinical Research Unit, Adelaide, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Cohort 1: Pathologically confirmed HER2-positive biliary tract cancer
  • 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

Treatment and study plan

YH32367

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 approximately 75 and 40 patients, respectively.

Primary outcomes

  1. Treatment-emergent adverse events (TEAEs) up to Day 21

    Time frame: in dose escalation part, an average of 21 days

    To assess the safety and tolerability of YH32367

  2. Objective Response Rate (ORR)

    Time frame: through dose expansion part completion, approximately 2.5 year

    To assess the ORR of YH32367 at the recommended Phase 2 dose (RP2D) according to RECIST v1.1 by blinded independent central reviews (BICR)

Secondary outcomes

  1. Area under the serum concentration-time curve from time 0 to the last quantifiable concentration (AUClast)

    Time frame: up to 66 weeks

    To characterize the PK of YH32367

  2. maximum observed serum concentration (Cmax)

    Time frame: up to 66 weeks

    To characterize the PK of YH32367

  3. time to reach Cmax (Tmax)

    Time frame: up to 66 weeks

    To characterize the PK of YH32367

  4. Presence and characterization of YH32367 ADA in serum including titer of ADA and neutralizing antibodies

    Time frame: through study completion, approximately 3.5 year

    To explore the immunogenicity of YH32367

  5. Objective Response Rate (ORR)

    Time frame: through study completion, approximately 3.5 year

    To assess the anti-tumor efficacy according to RECIST v1.1 by Investigator assessment

  6. Duration of Response (DoR)

    Time frame: through study completion, approximately 3.5 year

    To assess the anti-tumor efficacy according to RECIST v1.1 by Investigator assessment

  7. Disease Control Rate (DCR)

    Time frame: through study completion, approximately 3.5 year

    To assess the anti-tumor efficacy according to RECIST v1.1 by Investigator assessment

  8. Depth of Response

    Time frame: through study completion, approximately 3.5 year

    To assess the anti-tumor efficacy according to RECIST v1.1 by Investigator assessment

  9. Time to Response

    Time frame: through study completion, approximately 3.5 year

    To assess the anti-tumor efficacy according to RECIST v1.1 by Investigator assessment

  10. Progression-free survival (PFS)

    Time frame: through study completion, approximately 3.5 year

    To assess the anti-tumor efficacy according to RECIST v1.1 by Investigator assessment

  11. TEAEs

    Time frame: through dose expansion part completion, approximately 2.5 year

    To assess the safety and tolerability of YH32367 at the RP2D

  12. Overall Survival (OS)

    Time frame: through study completion, approximately 3.5 year

    To assess overall survival of YH32367

Other outcomes

  1. Immune ORR (iORR)

    Time frame: through study completion, approximately 3.5 year

    To assess the immune-related efficacy according to iRECIST by Investigator assessment

  2. Immune Duration of Response (iDOR)

    Time frame: through study completion, approximately 3.5 year

    To assess the immune-related efficacy according to iRECIST by Investigator assessment

  3. Immune PFS (iPFS)

    Time frame: through study completion, approximately 3.5 year

    To assess the immune-related efficacy according to iRECIST by Investigator assessment

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Operation Team 1

CONTACT

[email protected]

+82-2-828-0065

Heayeon Yoo

CONTACT

[email protected]

+82-2-828-0065

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study title

A Phase 1/2, Open-label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of YH32367 in Patients With HER2-Positive Locally Advanced or Metastatic Solid Tumors

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Sep 1, 2022
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.