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

September 29, 2026 updated by: Suzhou Genhouse Bio Co., Ltd.

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 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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
        • Principal Investigator:
          • Lin Zhao, Doctorate
      • Beijing, Beijing Municipality, China, 100021
        • Recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Contact:
        • Principal Investigator:
          • Ning Li, Doctorate
      • Beijing, Beijing Municipality, China, 100044
        • Recruiting
        • Peking University People's Hospital
        • Contact:
        • Principal Investigator:
          • Lu Xie, Doctorate
      • Beijing, Beijing Municipality, China, 100070
        • Active, not recruiting
        • Beijing Tiantan Hospital,Capital Medical University
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Recruiting
        • Fujian Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Yunjian Huang, Doctorate
      • Xiamen, Fujian, China, 361003
        • Recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:
        • Principal Investigator:
          • Jianbo Chen, Doctorate
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • Recruiting
        • Gansu Provincial Hospital
        • Contact:
        • Principal Investigator:
          • Bo Li, Doctorate
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
          • Xing Zhang, Doctorate
        • Principal Investigator:
          • Xing Zhang, Doctorate
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital
        • Contact:
        • Principal Investigator:
          • Laiyu Liu, Doctorate
    • Guangxi
      • Nanning, Guangxi, China, 530200
        • Recruiting
        • Guangxi Medical University Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Yongkui Lu, Doctorate
    • Guizhou
      • Guiyang, Guizhou, China, 550081
        • Recruiting
        • The Second People's Hospital of Guiyang
        • Contact:
        • Principal Investigator:
          • Zhuang Kang, Doctorate
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Qiming Wang, Doctorate
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
          • Jing Chen, Doctorate
        • Principal Investigator:
          • Jing Chen, Doctorate
    • Hunan
      • Changsha, Hunan, China, 410008
        • Recruiting
        • Xiangya Hospital of Central South University
        • Contact:
        • Principal Investigator:
          • Huaping Yang, Doctorate
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • Nanjing Drum Tower Hospital
        • Contact:
        • Principal Investigator:
          • Rutian Li, Doctorate
    • Jilin
      • Changchun, Jilin, China, 130033
        • Active, not recruiting
        • China-Japan Union Hospital of Jilin University
    • Shandong
      • Binzhou, Shandong, China, 256603
        • Recruiting
        • Shandong Medical and Pharmaceutical University Hospital
        • Contact:
        • Principal Investigator:
          • Fangling Ning, Doctorate
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200233
        • Recruiting
        • Shanghai Sixth People's Hospital
        • Contact:
        • Principal Investigator:
          • Haiyan Hu, Doctorate
      • Shanghai, Shanghai Municipality, China, 201200
        • Recruiting
        • Shanghai GoBroad Caner Hospital China Pharmaceutical University
        • Contact:
        • Principal Investigator:
          • Yayi He, Doctorate
    • Shanxi
      • Taiyuan, Shanxi, China, 30009
        • Recruiting
        • Shanxi Provincial Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Wei Guo, Doctorate
    • Sichuan
      • Yibin, Sichuan, China, 644000
        • Recruiting
        • The Second People's Hospital of Yibin
        • Contact:
        • Principal Investigator:
          • Kaijian Lei, Doctorate
    • Uygur Autonomous Region
      • Ürümqi, Uygur Autonomous Region, China, 830054
        • Recruiting
        • The First Teaching Hospital of Xinjiang Medical University
        • Contact:
        • Principal Investigator:
          • Ji Chen, Doctorate
        • Principal Investigator:
          • Shaya Mahati, Doctorate
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Zhengbo Song, Doctorate
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Contact:
        • Principal Investigator:
          • Binghao Li, Doctorate
      • Taizhou, Zhejiang, China, 317000
        • Recruiting
        • Taizhou Hospital of Zhejiang Province
        • Contact:
        • Principal Investigator:
          • Dongqing Lv, Doctorate

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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. 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
  3. Has symptomatic or active progressive central nervous system (CNS) metastases such as molluscum contagiosum metastases.
  4. 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.
  5. 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.
  6. Uncontrolled or significant cardiovascular disease
  7. 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).
  8. Conditions that the investigator considers inappropriate for participation in this clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GH56 Capsule Group

Dose-escalation cohorts and dose-expansion cohorts receiving varying doses of GH56.
Drug: GH56 Capsule

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1. Determination of Maximum Tolerated Dose (MTD) , RDEs of GH56.
Time Frame: Approximately 3 years

MTD is the highest dose of a treatment that does not cause unacceptable side effects.

RDEs stand for Recommended Dose for Expansion.
Approximately 3 years
Characterize the Safety of GH56
Time Frame: Approximately 3 years

Number of participants with treatment-emergent adverse events and serious AEs.
Approximately 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Approximately 3 years

Based on assessment of radiographic imaging per RECIST version 1.1
Approximately 3 years
Disease Control Rate (DCR)
Time Frame: Approximately 3 years

Based on assessment of radiographic imaging per RECIST version 1.1
Approximately 3 years
Duration of Response (DOR)
Time Frame: Approximately 3 years

Based on assessment of radiographic imaging per RECIST version 1.1
Approximately 3 years
Progression-Free Survival (PFS)
Time Frame: Approximately 3 years

Based on assessment of radiographic imaging per RECIST version 1.1
Approximately 3 years
Cmax
Time Frame: Approximately 3 years

The maximum or "peak" concentration of GH56 observed after administration
Approximately 3 years
Tmax
Time Frame: Approximately 3 years

The time to peak concentration of GH56
Approximately 3 years
T1/2
Time Frame: Approximately 3 years

Half-life of GH56
Approximately 3 years
PD of GH56
Time Frame: Approximately 3 years

Change of sDMA protein expression in tumor tissues
Approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suzhou Genhouse Bio Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

February 29, 2028

Study Registration Dates

First Submitted

January 22, 2025

First Submitted That Met QC Criteria

January 22, 2025

First Posted (Actual)

January 28, 2025

Study Record Updates

Last Update Posted (Actual)

October 2, 2026

Last Update Submitted That Met QC Criteria

September 29, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • GH56C101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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