A Phase Ia/Ib Clinical Study of GH56 Capsules in Subjects With MTAP-Deleted Advanced Solid Tumors（G-MAP 101）

Korábbi kezelés

• Subject has not recovered from a prior surgical procedure or has undergone any major surgery within 4 weeks prior to the first dose.
• 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
• 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.

Más betegség

• 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.
• Uncontrolled or significant cardiovascular disease
• 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).
• Conditions that the investigator considers inappropriate for participation in this clinical trial.

Egyéb

• Has symptomatic or active progressive central nervous system (CNS) metastases such as molluscum contagiosum metastases.

• Willing to participate in the clinical trial, understand and sign the informed consent, and comply with the study visits and procedures.
• Male and female patients who are ≥12 years of age at consent .
• Histologically or cytologically confirmed advanced and/or metastatic malignancies with progression on / intolerance to standard treatment or lack of effective standard treatment.
• Evidence of MTAP loss or homozygous MTAP/CDKN2A deletion in tumor tissue.
• At least one measurable lesion as per RECIST v1.1 criteria.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
• Survival expectations ≥ 12 weeks.
• Adequate organ function
• Has a negative serum pregnancy test result at screening and is able to comply with contraceptive-barrier requirements.