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

NCT ID: NCT05165849

Last Updated: 2022-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-30

Study Completion Date

2022-05-11

Brief Summary

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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

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Conditions

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Solid Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

GFS101A

Intervention Type DRUG

GFS101A will be administrated intravenously Q3W.

Toripalimab

Intervention Type DRUG

Toripalimab with fixed dose of 240 mg Q3W administered intravenously.

Interventions

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GFS101A

GFS101A will be administrated intravenously Q3W.

Intervention Type DRUG

Toripalimab

Toripalimab with fixed dose of 240 mg Q3W administered intravenously.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang Genfleet Therapeutics Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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GFS101AX0101

Identifier Type: -

Identifier Source: org_study_id

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