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

Launched by SUZHOU GENHOUSE BIO CO., LTD. · Jan 22, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called GH56 capsules for patients with advanced solid tumors that have a specific genetic change known as MTAP deletion. The trial aims to find out if GH56 is safe, how well it works, and the best dose to give. It’s designed for people who have already tried standard treatments without success or who don’t have other treatment options available. The study has two parts: the first part will gradually increase the dose to find the right amount, and the second part will include more people at that dose to see how effective it is.

To participate, individuals must be at least 18 years old and have advanced solid tumors with the MTAP deletion. They should also be in decent health, able to attend study visits, and have at least one measurable tumor. Participants can expect regular check-ins to monitor their health and how their tumors respond to the treatment. It's important to note that individuals with certain medical conditions or recent treatments may not be eligible for this trial, so potential participants should discuss their situation with their healthcare team.

Gender

ALL

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.