A Phase Ia/Ib Clinical Study of GH56 Capsules in Subjects With MTAP-Deleted Advanced Solid Tumors（G-MAP 101）
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age12+
SponsorSuzhou Genhouse Bio Co., Ltd.
About this trial
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 to 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).The Part Ib dose expansion study includes adult cohort and adolescent cohort (12-17 years of age).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Has symptomatic or active progressive central nervous system (CNS) metastases such as molluscum contagiosum metastases.
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.
Trial design
Design model
Single group
Treatments tested in this trial
GH56 Capsule
DrugGH56 capsule for oral administration at specified doses on scheduled days.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: GH56 Capsule GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Approximately 3 years2
Characterize the Safety of GH56
Number of participants with treatment-emergent adverse events and serious AEs.
Time frame
Approximately 3 yearsSecondary outcomes
1
Objective Response Rate (ORR)
Based on assessment of radiographic imaging per RECIST version 1.1
Time frame
Approximately 3 years2
Disease Control Rate (DCR)
Based on assessment of radiographic imaging per RECIST version 1.1
Time frame
Approximately 3 years3
Duration of Response (DOR)
Based on assessment of radiographic imaging per RECIST version 1.1
Time frame
Approximately 3 years4
Progression-Free Survival (PFS)
Based on assessment of radiographic imaging per RECIST version 1.1
Time frame
Approximately 3 yearsSponsors and contacts
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Source ClinicalTrials.gov