Advanced Solid Tumors With MTAP DeletionPhase 1NCT06796699
A Phase Ia/Ib Clinical Study of GH56 Capsules in Subjects With MTAP-Deleted Advanced Solid Tumors（G-MAP 101）
A Phase 1 study testing GH56 Capsule in people with Advanced Solid Tumors With MTAP Deletion, run by Suzhou Genhouse Bio Co., Ltd. at 25 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Advanced Solid Tumors With MTAP Deletion
- What is being tested?
- GH56 Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 25 sitesChina
- Study dates
- 7 Mar 2025to 29 Feb 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
- 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.
- 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.
Trial locations and contacts
25 sites in 1 country. Contact the study team or a site near you to ask about taking part.
25 sites in 1 country
China25 sites, 23 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Ning Li, Doctorate, +86-010-87788495, lining@cicams.ac.cn
Ning Li, Doctorate
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Lu Xie, Doctorate, xielu@pkuph.edu.cn
Lu Xie, Doctorate
- Active, not recruiting
Beijing Tiantan Hospital,Capital Medical University
Beijing, Beijing Municipality, 100070
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Lin Zhao, Doctorate, zhaolin4412@pumch.cn
Lin Zhao, Doctorate
- Recruiting
Shandong Medical and Pharmaceutical University Hospital
Binzhou, Shandong, 256603
Fangling Ning, Doctorate, ningfangling@126.com
Fangling Ning, Doctorate
- Active, not recruiting
China-Japan Union Hospital of Jilin University
Changchun, Jilin, 130033
- Recruiting
Xiangya Hospital of Central South University
Changsha, Hunan, 410008
Huaping Yang, Doctorate, lyhuaping@aliyun.com
Huaping Yang, Doctorate
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Yunjian Huang, Doctorate, 13805099580@126.com
Yunjian Huang, Doctorate
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Xing Zhang, Doctorate
Xing Zhang, Doctorate
- Recruiting
Nanfang Hospital
Guangzhou, Guangdong, 510515
Laiyu Liu, Doctorate, liulaiyu@126.com
Laiyu Liu, Doctorate
- Recruiting
The Second People's Hospital of Guiyang
Guiyang, Guizhou, 550081
Zhuang Kang, Doctorate, kzhaoren1984@163.com
Zhuang Kang, Doctorate
- Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Binghao Li, Doctorate, libinghaohz@163.com
Binghao Li, Doctorate
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Zhengbo Song, Doctorate, songzb@zjcc.org.cn
Zhengbo Song, Doctorate
- Recruiting
Gansu Provincial Hospital
Lanzhou, Gansu, 730000
Bo Li, Doctorate, doctorli2022@163.com
Bo Li, Doctorate
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
Rutian Li, Doctorate, li_rutian@163.com
Rutian Li, Doctorate
- Recruiting
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530200
Yongkui Lu, Doctorate, luyongkui616@126.com
Yongkui Lu, Doctorate
- Recruiting
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233
Haiyan Hu, Doctorate, +86-021-64369181, xuri1104@163.com
Haiyan Hu, Doctorate
- Recruiting
Shanghai GoBroad Caner Hospital China Pharmaceutical University
Shanghai, Shanghai Municipality, 201200
Yayi He, Doctorate, +86-021-60571205, doctorjael@qq.com
Yayi He, Doctorate
- Recruiting
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 30009
Wei Guo, Doctorate, +86-0351-4881611, guowei812@126.com
Wei Guo, Doctorate
- Recruiting
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, 317000
Dongqing Lv, Doctorate, lvdq855@126.com
Dongqing Lv, Doctorate
- Recruiting
The First Teaching Hospital of Xinjiang Medical University
Ürümqi, Uygur Autonomous Region, 830054
Shaya Mahati, Doctorate, 398022226@qq.com
Ji Chen, Doctorate
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Jing Chen, Doctorate
Jing Chen, Doctorate
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
Jianbo Chen, Doctorate, 274439002@qq.com
Jianbo Chen, Doctorate
- Recruiting
The Second People's Hospital of Yibin
Yibin, Sichuan, 644000
Kaijian Lei, Doctorate, lkj600@163.com
Kaijian Lei, Doctorate
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Qiming Wang, Doctorate, qimingwang1006@126.com
Qiming Wang, Doctorate
About this study
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
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).
- Conditions
- Advanced Solid Tumors With MTAP Deletion
- Being tested
- GH56 Capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GH56 CapsuleDrug
GH56 capsule for oral administration at specified doses on scheduled days.
| Study group | Role | What they receive |
|---|---|---|
| GH56 Capsule Group | Experimental | Dose-escalation cohorts and dose-expansion cohorts receiving varying doses of GH56. Receives: Drug: GH56 Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 3 years
Characterize the Safety of GH56
Number of participants with treatment-emergent adverse events and serious AEs.
Measured: Approximately 3 years
Secondary outcomes (8)
Objective Response Rate (ORR)
Based on assessment of radiographic imaging per RECIST version 1.1
Measured: Approximately 3 years
Disease Control Rate (DCR)
Based on assessment of radiographic imaging per RECIST version 1.1
Measured: Approximately 3 years
Duration of Response (DOR)
Based on assessment of radiographic imaging per RECIST version 1.1
Measured: Approximately 3 years
Progression-Free Survival (PFS)
Based on assessment of radiographic imaging per RECIST version 1.1
Measured: Approximately 3 years
Cmax
The maximum or "peak" concentration of GH56 observed after administration
Measured: Approximately 3 years
Tmax
The time to peak concentration of GH56
Measured: Approximately 3 years
T1/2
Half-life of GH56
Measured: Approximately 3 years
PD of GH56
Change of sDMA protein expression in tumor tissues
Measured: Approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start7 Mar 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid Tumors With MTAP DeletionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Genhouse Bio Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06796699
- Sponsor's protocol ID
- GH56C101
- Status last verified
- Sep 2026
- First submitted
- 22 Jan 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No