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

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.

Study Overview

• Status: Withdrawn
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: GFS101A; Drug: Toripalimab

• Study Type: Interventional
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: GFS101A; GFS101A will be administrated intravenously Q3W.; Drug: Toripalimab; Toripalimab with fixed dose of 240 mg Q3W administered intravenously.

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Zhejiang Genfleet Therapeutics Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2022
• Primary Completion (Actual): May 11, 2022
• Study Completion (Actual): May 11, 2022

Study Registration Dates

• First Submitted: December 6, 2021
• First Submitted That Met QC Criteria: December 16, 2021
• First Posted (Actual): December 21, 2021

Study Record Updates

• Last Update Posted (Actual): May 20, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: GFS101AX0101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No