Clinical Trials Logo
  1. Home
  2. Solid Tumor
  3. NCT05165849
  4. Details
NCT05165849 Clinical Trial

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

Solid Tumor Clinical Trial

Official title:
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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT05165849
Other study ID # GFS101AX0101
Secondary ID
Status Withdrawn
Phase Phase 1/Phase 2
First received
Last updated
Start date April 2022
Est. completion date May 11, 2022

Study information
Verified date May 2022
Source Genfleet Therapeutics (Shanghai) Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date May 11, 2022
Est. primary completion date May 11, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• GFS101A
GFS101A will be administrated intravenously Q3W.
• Toripalimab
Toripalimab with fixed dose of 240 mg Q3W administered intravenously.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Zhejiang Genfleet Therapeutics Co., Ltd.

Outcome
Type Measure Description Time frame Safety issue
Primary Phase I:Incidence of dose limiting toxicity (DLT) events 21days
Primary Phase II: Overall response rate (ORR) per RECIST 1.1 approximately 12 months after first dose
See also
  Status Clinical Trial Phase
Recruiting NCT05691608 - MoleculAr Profiling for Pediatric and Young Adult Cancer Treatment Stratification 2 N/A
Recruiting NCT05580991 - Intratumoral CAN1012(Selective TLR7 Agonist) in Subjects With Solid Tumors Phase 1
Active, not recruiting NCT02846038 - Understanding Communication in Healthcare to Achieve Trust (U-CHAT)
Recruiting NCT05159388 - A Study of PRS-344/S095012 (PD-L1x4-1BB Bispecific Antibody-Anticalin Fusion) in Patients With Solid Tumors Phase 1/Phase 2
Completed NCT03181854 - Randomized Controlled Trial of Integrated Early Palliative Care N/A
Recruiting NCT06014502 - Study to Evaluate IMGS-001 Treatment in Patients With Relapsed or Refractory Advanced Solid Tumors Phase 1
Recruiting NCT05981703 - A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors Phase 1
Recruiting NCT04107311 - Prospective Analysis of Intestinal Microbiome and Autoimmune Panels as Predictors of Toxicity in ImmunOncology Patients
Active, not recruiting NCT04078152 - Durvalumab Long-Term Safety and Efficacy Study Phase 4
Completed NCT02250157 - A Dose-regimen Finding Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oratecan in Subjects With Advanced Malignancies Phase 1
Recruiting NCT05566574 - A Study of RP-3500 in Combination With Standard Radiation Therapy in People With Solid Tumor Cancer Phase 1/Phase 2
Recruiting NCT03943004 - Trial of DFP-14927 in Advanced Solid Tumors Phase 1
Recruiting NCT06036836 - Study of Favezelimab Coformulated With Pembrolizumab (MK-4280A) in Participants With Selected Solid Tumors (MK-4280A-010) Phase 2
Recruiting NCT05798546 - Treatment of Advanced Solid Tumors With Neo-T(GI-NeoT-02) Phase 1
Recruiting NCT05525858 - KPMNG Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II
Terminated NCT04586335 - Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors. Phase 1
Active, not recruiting NCT00479128 - Bortezomib With Gemcitabine/Doxorubicin in Patients With Urothelial Cancer and Other Solid Tumors Phase 1
Recruiting NCT04143789 - Evaluation of AP-002 in Patients With Solid Tumors Phase 1/Phase 2
Not yet recruiting NCT04550663 - NKG2D CAR-T(KD-025) in the Treatment of Relapsed or Refractory NKG2DL+ Tumors Phase 1
Completed NCT03980041 - Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275) Phase 2