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
- Are there results?
- Not yet: the study is under way
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.
Show all 9Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06796699
- Acronym / sponsor ID
- GH56C101
- Conditions
- Advanced Solid Tumors With MTAP Deletion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Suzhou Genhouse Bio Co., Ltd.University, hospital or other
- Study start
- 7 Mar 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GH56 Capsule Group | Experimental | Drug: GH56 CapsuleDose-escalation cohorts and dose-expansion cohorts receiving varying doses of GH56. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GH56 CapsuleGH56 capsule for oral administration at specified doses on scheduled days. | Drug | GH56 Capsule Group |
Primary outcome
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.
Characterize the Safety of GH56
Time frame: Approximately 3 years
Number of participants with treatment-emergent adverse events and serious AEs.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
Related trials for Advanced Solid Tumors With MTAP Deletion
RecruitingPhase 2
A Study of Navlimetostat (BMS-986504) Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)
Solid Tumors
RecruitingPhase 1
Study of GS-5319 Given Alone or in Combination in Adults With Solid Tumors
Advanced Solid Tumor
RecruitingPhase 1
Study of GS-2426 in Participants With Advanced Solid Tumors
Advanced Solid Tumors
Active, not recruitingPhase 1/2
S095035 as a Single Agent and in Combination in Adult Participants With Advanced or Metastatic Solid Tumors With Deletion of MTAP
MTAP-deleted Solid Tumors
RecruitingPhase 1
A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors
NSCLC Adenocarcinoma, Gastroesophageal Cancer (GC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bo Ning, Master (+86-0512-86861608, nibo@genhousebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Determination of Maximum Tolerated Dose (MTD) , RDEs of GH56. (time frame: Approximately 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.