A Phase Ia/Ib Clinical Study of GH56 Capsules in Subjects With MTAP-Deleted Advanced Solid Tumors

A Multi-center, Single-Arm, Open-Label Phase Ia/Ib Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of GH56 Capsules in Subjects With MTAP-Deleted Advanced Solid Tumors

This is a multicenter, single-arm, open-label, dose-escalation, dose-expansion study to evaluate the safety, tolerability, PK/PD, and preliminary anti-tumor activity of GH56 Capsule in subjects with advanced solid tumors who have failed or are intolerant in standard treatment, or have no standard therapy. The clinical trial will be carried out in two parts: phase Ia study (dose escalation study) and phase Ib (dose expansion study).

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumors With MTAP Gene Deletion
• Intervention / Treatment: Drug: GH56 Capsule

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yiming Zhou, Bachelor; Phone Number: +86-0512-86861608; Email: zhouyiming@genhousebio.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Recruiting
      • Cancer Hospital Chinese Academy of Medical Sciences
      • Contact: Ning Li, Doctorate; Phone Number: +86-010-87788495; Email: lining@cicams.ac.cn
      • Principal Investigator: Ning Li, Doctorate
  • Shanghai
    • Shanghai, Shanghai, China, 200233
      • Not yet recruiting
      • Shanghai Sixth People's Hospital
      • Contact: Haiyan Hu, Doctorate; Phone Number: +86-021-64369181; Email: xuri1104@163.com
      • Principal Investigator: Haiyan Hu, Doctorate
    • Shanghai, Shanghai, China, 201200
      • Not yet recruiting
      • Shanghai GoBroad Caner Hospital China Pharmaceutical University
      • Contact: Yayi He, Doctorate; Phone Number: +86-021-60571205; Email: doctorjael@qq.com
      • Principal Investigator: Yayi He, Doctorate
  • Shanxi
    • Taiyuan, Shanxi, China, 30009
      • Not yet recruiting
      • Shanxi Provincial Cancer Hospital
      • Contact: Yinan Shi, Doctorate; Phone Number: +86-0351-4881611; Email: elizabethen@126.com
      • Principal Investigator: Yinan Shi, Doctorate

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1. Willing to participate in the clinical trial, understand and sign the informed consent, and comply with the study visits and procedures.
• 2. Men or women ≥18 years old.
• 3. Men or women with MTAP-Deleted Advanced Solid Tumors.
• 4. Subjects with solid tumors must have at least one evaluable lesion which should be measurable by RECIST v1.1.
• 5. Eastern Cooperative Oncology Group (ECOG) performance status (Table 12) 0 to 1.
• 6. Survival expectations ≥ 12 weeks.
• 7. Subjects with adequate organ function and the laboratory test critera.
• 8. Serum pregnancy test (for female of childbearing potential) negative within 7 days prior to first dosing of study treatment. Male and female subjects of childbearing potential must agree to use effective methods of contraception from the time of ICF signed, throughout the study and for 6 months after the last dose of the investigational product. A patient is of childbearing potential if, in the opinion of the Investigator, he/she is biologically capable of having children and is sexually active.

Exclusion Criteria:

• 1. Subject has not recovered from a prior surgical procedure or has undergone any major surgery within 4 weeks prior to the first dose.
• 2. Known (including suspected) allergic to GH56 or its components.
• 3. Has received any anti-tumor agents within 28 days without delayed toxicity for the treatment of advanced tumors prior to the first administration of GH56 Capsule or has received radiation therapy, biologic therapy, endocrine therapy, targeted therapy, immunotherapy, or other anti-tumor drug treatments within 28 days prior to the first administration of GH56 Capsule, or other anti-tumor drugs or treatments within the following interval before the first administration of GH56 Capsule.
• 4. Has symptomatic or active progressive central nervous system (CNS) metastases such as molluscum contagiosum metastases.
• 5. Subjects who have difficulty in swallowing and have a history of gastrointestinal surgery or other relevant medical disorders that may interfere with the absorption of GH56.
• 6. Subjects had a malignant tumor other than the current tumor within 5 years prior to the first administration of GH56 Capsule, except for localized cancers that have been apparently cured or without disease progression or recurrence for at least 5 consecutive years.
• 7. Uncontrolled or significant cardiovascular disease
• 8. Subjects with documented positive virology status of hepatitis, as confirmed by Screening hepatitis B virus (HBV) and hepatitis C virus (HCV) tests, Human Immunodeficiency Virus (HIV).
• 9. Conditions that the investigator considers inappropriate for participation in this clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GH56 Capsule Group; Participants will be randomized to receive one of 6 active dose levels of GH56 orally (PO) daily (QD) in 21 days cycles. The study will determine the recommended dose of expansion (RDEs) and RP2D.	Drug: GH56 Capsule; GH56 capsule for oral administration at specified doses on scheduled days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Determination of Maximum Tolerated Dose (MTD) , RDEs of GH56.	MTD is the highest dose of a treatment that does not cause unacceptable side effects. RDEs stand for Recommended Dose for Expansion.	Approximately 3 years
Characterize the Safety of GH56	Number of participants with treatment-emergent adverse events and serious AEs.	Approximately 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	Based on assessment of radiographic imaging per RECIST version 1.1	Approximately 3 years
Disease Control Rate (DCR)	Based on assessment of radiographic imaging per RECIST version 1.1	Approximately 3 years
Duration of Response (DOR)	Based on assessment of radiographic imaging per RECIST version 1.1	Approximately 3 years
Progression-Free Survival (PFS)	Based on assessment of radiographic imaging per RECIST version 1.1	Approximately 3 years
Cmax	The maximum or "peak" concentration of GH56 observed after administration	Approximately 3 years
Tmax	The time to peak concentration of GH56	Approximately 3 years
T1/2	Half-life of GH56	Approximately 3 years
PD of GH56	Change of sDMA protein expression in tumor tissues	Approximately 3 years

Collaborators and Investigators

• Sponsor: Suzhou Genhouse Bio Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): February 29, 2028

Study Registration Dates

• First Submitted: January 22, 2025
• First Submitted That Met QC Criteria: January 22, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 28, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: GH56C101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No