NCT05165849

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2022

Shorter than P25 for phase_1

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 21, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2022

Completed
Last Updated

May 20, 2022

Status Verified

May 1, 2022

Enrollment Period

1 month

First QC Date

December 6, 2021

Last Update Submit

May 16, 2022

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

GFS101A+Toripalimab

EXPERIMENTAL

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

Drug: GFS101ADrug: Toripalimab

Interventions

GFS101ADRUG

GFS101A will be administrated intravenously Q3W.

GFS101A+Toripalimab
ToripalimabDRUG

Toripalimab with fixed dose of 240 mg Q3W administered intravenously.

GFS101A+Toripalimab

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Voluntarily participate in this clinical trial, and are willing to sign informed consent forms.
  • Male or female aged from 18-75 years old (inclusive).
  • Diagnosed with histologically or cytologically confirmed advanced solid tumors.
  • Evaluable lesions defined by RECIST v1.1.
  • Eastern Cooperative Oncology Group performance status of 0 to 1.
  • Subjects or their legal representatives are able to communicate well with Investigators and are willing to comply with the protocol and complete the study.

You may not qualify if:

  • With clinically significant cardiac diseases
  • With clinically significant digestive disorders.
  • Other severe disease.
  • Pregnant or lactating women.
  • Other unfavorable situations for subjects to participate in the study judged by Investigators.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

toripalimab
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2021

First Posted

December 21, 2021

Study Start

April 1, 2022

Primary Completion

May 11, 2022

Study Completion

May 11, 2022

Last Updated

May 20, 2022

Record last verified: 2022-05