A Study of GFH018 in Combination With Toripalimab in Patients With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT04914286|
Recruitment Status : Recruiting
First Posted : June 4, 2021
Last Update Posted : February 1, 2022
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumor||Drug: GFH018 Drug: Toripalimab||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||195 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-center, Single-arm, and Open-label Phase Ib/II Study Exploring the Safety/Tolerability, Pharmacokinetics, and Efficacy of GFH018 in Combination With Toripalimab in the Treatment of Patients With Advanced Solid Tumors|
|Actual Study Start Date :||October 20, 2021|
|Estimated Primary Completion Date :||July 10, 2023|
|Estimated Study Completion Date :||November 10, 2023|
Patient will be dosed in GFH018 in combination with Toripalimab. In the PhaseIb part, the dose levels will be escalated following the Bayesian optimal interval (BOIN) design. In the Phase II part, patients will be assigned based on tumor type(s).
Subjects are planned to be dosed in oral GFH018 tablets twice daily for a continuous 14 days in a 28 days cycle (7days on 7days off may be tested based on available data from phase I dose escalation study of single agent). the starting dose of GFH018 will be derived from the maximum safe dose explored in rom phase I dose escalation study of single agent.
Subjects are planned to be dosed at 3 mg/kg Toripalimab as an intravenous infusion once every 2 weeks.
- Phase Ib：Incidence of dose-limiting toxicity (DLT) events [ Time Frame: 28 days ]
- Phase II: ORR (Objective Response Rate) [ Time Frame: approximately 6 months after first dose ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04914286
|Contact: Jin Li||+86 21 6882 firstname.lastname@example.org|
|Australia, Western Australia|
|Linear Clinical Research Ltd||Recruiting|
|Perth, Western Australia, Australia|
|Contact: Michael Millward 0863825100 email@example.com|