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Recruiting NCT06796699

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

Phase I Interventional Advanced Solid Tumors With MTAP Gene Deletion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GH56 Capsule.
Who it may be relevant to
Registry conditions: Advanced Solid Tumors With MTAP Gene Deletion. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • Drug GH56 Capsule
    GH56 capsule for oral administration at specified doses on scheduled days.

Primary outcome measures

  • 1. Determination of Maximum Tolerated Dose (MTD) , RDEs of GH56. [Time frame: Approximately 3 years]
  • Characterize the Safety of GH56 [Time frame: Approximately 3 years]
Secondary outcome measures (8)
  • Objective Response Rate (ORR) [Time frame: Approximately 3 years]
  • Disease Control Rate (DCR) [Time frame: Approximately 3 years]
  • Duration of Response (DOR) [Time frame: Approximately 3 years]
  • Progression-Free Survival (PFS) [Time frame: Approximately 3 years]
  • Cmax [Time frame: Approximately 3 years]
  • Tmax [Time frame: Approximately 3 years]
  • T1/2 [Time frame: Approximately 3 years]
  • PD of GH56 [Time frame: Approximately 3 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 4 centers
  • Cancer Hospital Chinese Academy of Medical Sciences — Beijing
  • Shanghai Sixth People's Hospital — Shanghai
  • Shanghai GoBroad Caner Hospital China Pharmaceutical University — Shanghai
  • Shanxi Provincial Cancer Hospital — Taiyuan

Identifiers

NCT: NCT06796699 · GH56C101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗