GH21 Capsules for Advanced Solid Tumors: A Study on Safety and Early Results
NCT ID: NCT05183243
Last Updated: 2024-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
68 participants
INTERVENTIONAL
2022-02-20
2025-02-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Estimate the maximum tolerated dose (MTD) in patients with advanced solid tumors.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
GenSci143 in Participants With Advanced Solid Tumors
NCT07252414
A Phase Ia/Ib Clinical Study of GH56 Capsules in Subjects With MTAP-Deleted Advanced Solid Tumors
NCT06796699
Phase I Trial to Investigate Cafusertib Hydrochloride Monotherapy in Chinese Patients With Advanced Solid Tumours
NCT02314884
A Study of GH21 Combined With Previous Target Therapy or Immunotherapy in Patients With Advanced Solid Tumors
NCT06322095
A Phase Ia/Ib Study of GH2616 Tablet in Subjects With Advanced Solid Tumors
NCT06329206
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Monotherapy Dose Escalation.
Treatment with GH21 alone, conducted until disease progression, intolerance or end of study.
GH21 Capsule
GH21 for oral administration at doses of Dose A, Dose B, Dose C, Dose D, Dose E and Dose F.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
GH21 Capsule
GH21 for oral administration at doses of Dose A, Dose B, Dose C, Dose D, Dose E and Dose F.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Written informed consent obtained prior to any study-related procedure being performed;
3. Subjects with life expectancy ≥3 months;
4. Eastern Cooperative Oncology Group performance score 0 - 2;
5. Subjects must have histologically or cytologically confirmed advanced or metastatic solid tumor;
6. At least one measurable lesion based on RECIST version 1.1 .
Exclusion Criteria
2. Have central nervous system metastases;
3. Prior treatment with SHP2 inhibitor;
4. Have major surgery within 28 days prior to the first dose of GH21;
5. Left ventricular ejection fraction (LVEF) \<50 %;
6. Females who are pregnant or breastfeeding ;
7. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection;
8. Conditions that the investigator considers inappropriate for participation in this clinical trial.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Suzhou Genhouse Bio Co., Ltd.
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Haidan Wang, Doctorate
Role: STUDY_DIRECTOR
0512-86861608
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, China
Beijing University Cancer Hospital
Beijing, Beijing Municipality, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province
Linhai, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GH21-CRS001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.