NCT05165849
Withdrawn
Phase 1
A Multicenter, Open-label, Phase I/Ⅱ Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Efficacy of GFS101A in Combination With Toripalimab Treating Patients With Advanced Solid Tumors
ConditionsSolid Tumor
Overview
- Phase
- Phase 1
- Intervention
- GFS101A
- Conditions
- Solid Tumor
- Sponsor
- Zhejiang Genfleet Therapeutics Co., Ltd.
- Primary Endpoint
- Phase II: Overall response rate (ORR) per RECIST 1.1
- Status
- Withdrawn
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety/tolerability, pharmacokinetics, and efficacy of GFS101A in combination with Toripalimab in patients with advanced solid tumors.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Voluntarily participate in this clinical trial, and are willing to sign informed consent forms.
- •Male or female aged from 18-75 years old (inclusive).
- •Diagnosed with histologically or cytologically confirmed advanced solid tumors.
- •Evaluable lesions defined by RECIST v1.
- •Eastern Cooperative Oncology Group performance status of 0 to
- •Subjects or their legal representatives are able to communicate well with Investigators and are willing to comply with the protocol and complete the study.
Exclusion Criteria
- •With clinically significant cardiac diseases
- •With clinically significant digestive disorders.
- •Other severe disease.
- •Pregnant or lactating women.
- •Other unfavorable situations for subjects to participate in the study judged by Investigators.
Arms & Interventions
GFS101A+Toripalimab
Patient will be administrated with GFS101A IV in combination with Toripalimab IV. The duration of the treatment cycle is defined as 21 days.
Intervention: GFS101A
GFS101A+Toripalimab
Patient will be administrated with GFS101A IV in combination with Toripalimab IV. The duration of the treatment cycle is defined as 21 days.
Intervention: Toripalimab
Outcomes
Primary Outcomes
Phase II: Overall response rate (ORR) per RECIST 1.1
Time Frame: approximately 12 months after first dose
Phase I：Incidence of dose limiting toxicity (DLT) events
Time Frame: 21days
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