A Phase Ia/Ib Study of GH2616 Tablet in Subjects With Advanced Solid Tumors
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ClinicalTrials.gov Identifier: NCT06329206 |
Recruitment Status :
Recruiting
First Posted : March 25, 2024
Last Update Posted : April 3, 2024
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Tracking Information | |||||||||
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First Submitted Date ICMJE | March 12, 2024 | ||||||||
First Posted Date ICMJE | March 25, 2024 | ||||||||
Last Update Posted Date | April 3, 2024 | ||||||||
Actual Study Start Date ICMJE | March 13, 2024 | ||||||||
Estimated Primary Completion Date | April 25, 2026 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Safety assessment [ Time Frame: 2 years ] Adverse events (AE), serious adverse events (SAE), and severity of AE using the NCI-CTCAE version 5.0.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | A Phase Ia/Ib Study of GH2616 Tablet in Subjects With Advanced Solid Tumors | ||||||||
Official Title ICMJE | A Phase Ia/Ib, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of GH2616 Tablet in Subjects With Advanced Solid Tumors | ||||||||
Brief Summary | This is a Phase Ia/Ib, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, pharmacodynamics (PD) and preliminary efficacy of GH2616 Tablet in subjects with advanced solid tumors. It includes two parts: the dose escalation study (Phase Ia) and the dose expansion study (Phase Ib). | ||||||||
Detailed Description | Phase Ia: Dose Escalation Study This is a Phase Ia, open-label, multi-center, dose escalation study, aiming to investigate the safety, tolerability, PK, PD and preliminary anti-tumor activity of GH2616 Tablet in subjects with advanced solid tumors. • Dose Escalation Phase This study will consist of 8, sequential, ascending-dose cohorts (A1~ A8) and utilize a "3+3" dose escalation design. The planned dose levels for each cohort (A1 ~ A8) are 50 mg, 100 mg, 200 mg, 400mg, 600 mg, 900 mg, 1200 mg and 1400 mg (tentative), respectively. GH2616 Tablet will be orally administered once daily for 21 consecutive days of each cycle. Phase Ib: Dose Expansion Study The Phase Ib part is an open-label, multi-center, dose expansion study, aiming to further evaluate the safety, tolerability, PK, PD, and preliminary anti-tumor activity of GH2616 Tablet in subjects with advanced solid tumors harboring TP53 mutation and WGD+ at the RDEs. Phase Ib study will consist of 2 to 3 dose level cohorts (B1 ~ B3) of RDEs identified by the safety, tolerability, PK/PD characteristics, and preliminary efficacy data obtained from Phase Ia study. Subjects will be orally administered GH2616 Tablet once daily in continuous 21-day cycle until the patients who have no benefits from the study judged by the Investigator, or experience disease progression, intolerable toxicity, death, loss to follow-up, withdrawal of informed consent, completion of 24 months of treatment or initiation of a new anti-tumor therapy,whichever comes first. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 1 | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Advanced Solid Tumors | ||||||||
Intervention ICMJE | Drug: GH2616 Tablets
GH2616 tablets will be given orally
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Study Arms ICMJE | Experimental: GH2616 GROUP
Dose Escalation: Dose Escalation Cohorts Subjects will be enrolled at various doses of GH2616. These Dose Escalation Cohorts will be utilized to To determine the maximum tolerated dose (MTD) and/or recommended dose for expansion(s) (RDEs) for Dose Expansion. Dose Escalation: Backfill Cohorts 2 ~ 3 dose cohorts are allowed to be backfilled.These Backfill Cohorts will be utilized to build additional data to support selection of doses and/or tumor types for further study in Dose Expansion. Dose Expansion: Expansion Cohorts 2 ~ 3 dose cohorts are planned.Subjects with advanced solid tumors harboring TP53 mutation and whole genome duplication (WGD+) will be enrolled.These Cohorts will be utilized to to determine the recommended Phase II dose (RP2D) of GH2616 Tablet. Intervention: Drug: GH2616 Tablets
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
156 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | September 1, 2026 | ||||||||
Estimated Primary Completion Date | April 25, 2026 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | China | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT06329206 | ||||||||
Other Study ID Numbers ICMJE | GH2616-101 | ||||||||
Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||
Current Responsible Party | Suzhou Genhouse Bio Co., Ltd. | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | Suzhou Genhouse Bio Co., Ltd. | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE |
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Investigators ICMJE | Not Provided | ||||||||
PRS Account | Suzhou Genhouse Bio Co., Ltd. | ||||||||
Verification Date | April 2024 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |