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

Phase 1

Withdrawn

• Conditions: Solid Tumor
• Interventions: Drug: GFS101A; Drug: Toripalimab

• Registration Number: NCT05165849
• Lead Sponsor: Zhejiang Genfleet Therapeutics Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-06
• Study First Submitted QC: 2021-12-16
• Study First Posted: 2021-12-21
• Study Start: 2022-04
• Status Verified: 2022-05
• Primary Completion: 2022-05-11
• Study Completion: 2022-05-11
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GFS101A+Toripalimab	GFS101A	Patient will be administrated with GFS101A IV in combination with Toripalimab IV. The duration of the treatment cycle is defined as 21 days.
GFS101A+Toripalimab	Toripalimab	Patient will be administrated with GFS101A IV in combination with Toripalimab IV. The duration of the treatment cycle is defined as 21 days.

Primary Outcome Measures

Name	Time	Method
Phase II: Overall response rate (ORR) per RECIST 1.1	approximately 12 months after first dose
Phase I：Incidence of dose limiting toxicity (DLT) events	21days