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

Phase 1

Recruiting

• Conditions: Advanced Solid Tumors With MTAP Gene Deletion
• Interventions: Drug: GH56 Capsule

• Registration Number: NCT06796699
• Lead Sponsor: Suzhou Genhouse Bio Co., Ltd.

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-22
• Study First Submitted QC: 2025-01-22
• Study Start: 2025-03-07
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-28
• Primary Completion: 2027-12-31
• Study Completion: 2028-02-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GH56 Capsule Group	GH56 Capsule	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Shanghai GoBroad Caner Hospital China Pharmaceutical University; 🇨🇳 Shanghai, Shanghai, China

Cancer Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China

Shanghai Sixth People's Hospital; 🇨🇳 Shanghai, Shanghai, China

Shanxi Provincial Cancer Hospital; 🇨🇳 Taiyuan, Shanxi, China