Testing GH56 Capsules in Patients with Advanced Solid Tumors Lacking MTAP Gene

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 study is testing GH56 capsules to see if they can help people with advanced solid tumors that lack the MTAP gene and have already tried other treatments without success.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Suzhou Genhouse Bio Co., Ltd. (Academic / other)
• Drugs / interventions: immunotherapy, radiation
• Locations: 4 sites (Beijing, Beijing Municipality and 3 other locations)
• Trial ID: NCT06796699 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of GH56 capsules in patients with advanced solid tumors that have a deletion of the MTAP gene. It is a multicenter, single-arm study that consists of two phases: a dose-escalation phase (Ia) to determine the appropriate dosage and a dose-expansion phase (Ib) to further assess the treatment's effects. Participants must have previously failed standard treatments or have no available standard therapies. The study aims to gather data on the drug's pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced solid tumors that have an MTAP gene deletion.

Not a fit: Patients with solid tumors that do not have an MTAP gene deletion or those who are not eligible for the study criteria may not benefit.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors lacking the MTAP gene.

How similar studies have performed: While there may be limited data on this specific approach, similar studies targeting genetic deletions in tumors have shown promise in the past.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality and 3 other locations

• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (Recruiting)
• Shanghai Sixth People's Hospital — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• Shanghai GoBroad Caner Hospital China Pharmaceutical University — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• Shanxi Provincial Cancer Hospital — Taiyuan, Shanxi, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Yiming Zhou, Bachelor

Conditions Advanced Solid Tumors With MTAP Gene Deletion