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

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

Status

Withdrawn

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05165849

Enrollment

Registered

2021-12-21

Start date

2022-04-30

Completion date

2022-05-11

Last updated

2022-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumor

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.

Interventions

DRUGGFS101A

GFS101A will be administrated intravenously Q3W.

DRUGToripalimab

Toripalimab with fixed dose of 240 mg Q3W administered intravenously.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026