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NCT05165849 Clinical Trial

A Study of GFS101A in Combination With Toripalimab in Patients With Advanced Solid Tumors

Solid Tumor Clinical Trial

Official title:
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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT05165849
Other study ID # GFS101AX0101
Secondary ID
Status Withdrawn
Phase Phase 1/Phase 2
First received
Last updated
Start date April 2022
Est. completion date May 11, 2022

Study information
Verified date May 2022
Source Genfleet Therapeutics (Shanghai) Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date May 11, 2022
Est. primary completion date May 11, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. Voluntarily participate in this clinical trial, and are willing to sign informed consent forms. 2. Male or female aged from 18-75 years old (inclusive). 3. Diagnosed with histologically or cytologically confirmed advanced solid tumors. 4. Evaluable lesions defined by RECIST v1.1. 5. Eastern Cooperative Oncology Group performance status of 0 to 1. 6. 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: 1. With clinically significant cardiac diseases 2. With clinically significant digestive disorders. 3. Other severe disease. 4. Pregnant or lactating women. 5. Other unfavorable situations for subjects to participate in the study judged by Investigators.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• GFS101A
GFS101A will be administrated intravenously Q3W.
• Toripalimab
Toripalimab with fixed dose of 240 mg Q3W administered intravenously.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Zhejiang Genfleet Therapeutics Co., Ltd.

Outcome
Type Measure Description Time frame Safety issue
Primary Phase I:Incidence of dose limiting toxicity (DLT) events 21days
Primary Phase II: Overall response rate (ORR) per RECIST 1.1 approximately 12 months after first dose
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