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

PHASE1PHASE2RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Pathologically confirmed HER2-positive

Mandatory provision of tumor tissue sample

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

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2022-08-26

Primary completion: 2026-10-01

Study completion finish: 2026-12-01

Study type

TREATMENT

Phase

PHASE1

PHASE2

Trial ID

NCT05523947

Intervention or treatment

DRUG: YH32367

Conditions

• HER2-Positive Solid Tumor

Image related to HER2-Positive Solid Tumor

Condition: HER2-Positive Solid Tumor
DRUG: YH32367
Melbourne, Not Specified, Australia and more
Sponsor: Yuhan Corporation

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Austin Health

Research sites nearby

Select from list below to view details:

Austin Health
Melbourne, Not Specified, Australia
Blacktown Hospital
Sydney, Not Specified, Australia
Southern Oncology Clinical Research Unit
Adelaide, Not Specified, Australia
Breast Cancer Research Centre - WA
Perth, Not Specified, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
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).	DRUG: 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.

Participant Group/Arm

Intervention/Treatment

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).

DRUG: 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.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Treatment-emergent adverse events (TEAEs) up to Day 21	To assess the safety and tolerability of YH32367	in dose escalation part, an average of 21 days
Objective Response Rate (ORR)	To assess the ORR of YH32367 at the recommended Phase 2 dose (RP2D) according to RECIST v1.1 by blinded independent central reviews (BICR)	through dose expansion part completion, approximately 2.5 year

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Area under the serum concentration-time curve from time 0 to the last quantifiable concentration (AUClast)	To characterize the PK of YH32367	up to 66 weeks
maximum observed serum concentration (Cmax)	To characterize the PK of YH32367	up to 66 weeks
time to reach Cmax (Tmax)	To characterize the PK of YH32367	up to 66 weeks
Presence and characterization of YH32367 ADA in serum including titer of ADA and neutralizing antibodies	To explore the immunogenicity of YH32367	through study completion, approximately 3.5 year
Objective Response Rate (ORR)	To assess the anti-tumor efficacy according to RECIST v1.1 by Investigator assessment	through study completion, approximately 3.5 year
Duration of Response (DoR)	To assess the anti-tumor efficacy according to RECIST v1.1 by Investigator assessment	through study completion, approximately 3.5 year
Disease Control Rate (DCR)	To assess the anti-tumor efficacy according to RECIST v1.1 by Investigator assessment	through study completion, approximately 3.5 year
Depth of Response	To assess the anti-tumor efficacy according to RECIST v1.1 by Investigator assessment	through study completion, approximately 3.5 year
Time to Response	To assess the anti-tumor efficacy according to RECIST v1.1 by Investigator assessment	through study completion, approximately 3.5 year
Progression-free survival (PFS)	To assess the anti-tumor efficacy according to RECIST v1.1 by Investigator assessment	through study completion, approximately 3.5 year
TEAEs	To assess the safety and tolerability of YH32367 at the RP2D	through dose expansion part completion, approximately 2.5 year
Overall Survival (OS)	To assess overall survival of YH32367	through study completion, approximately 3.5 year

Frequently Asked Questions

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References

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