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

GenFleet Therapeutics

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Solid Tumor

Treatments: Drug: Toripalimab; Drug: GFS101A

Study type: Interventional

Funder types: Industry

Identifiers

NCT05165849

GFS101AX0101

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

GFS101A+Toripalimab

Experimental group

Description:

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

Treatment:

Drug: Toripalimab

Drug: GFS101A