A Multi-center, Single-arm, and Open-label Phase Ib/II Study Exploring the Safety/Tolerability, Pharmacokinetics, and Efficacy of GFH018 in Combination With Toripalimab in the Treatment of Patients With Advanced Solid Tumors

Genfleet Therapeutics (Shanghai) Inc.3 sites in 2 countries148 target enrollmentOctober 20, 2021

ConditionsAdvanced Solid Tumor

InterventionsGFH018 Toripalimab

DrugsGFH018 Toripalimab

Overview

Phase: Phase 1
Intervention: GFH018
Conditions: Advanced Solid Tumor
Sponsor: Genfleet Therapeutics (Shanghai) Inc.
Enrollment: 148
Locations: 3
Primary Endpoint: Phase Ib：Incidence of dose-limiting toxicity (DLT) events
Status: Completed
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to evaluate the safety/tolerability, pharmacokinetics, and preliminary efficacy of GFH018 in combination with Toripalimab in patients with advanced solid tumors.

Registry

clinicaltrials.gov

Start Date

October 20, 2021

End Date

December 31, 2023

Last Updated

11 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Genfleet Therapeutics (Shanghai) Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Has histologically or cytologically confirmed diagnosis of advanced or metastatic solid tumors, progressed on at least first line therapy.
•Has sufficient organ functions.
•Eastern Cooperative Oncology Group Performance Status (ECOG P.S.) ≤
•Subject with tumor involvement of the liver must have the Child-Pugh score of 0-
•Life expectancy≥12 weeks.
•Female or male subjects of child-bearing potential must agree to use effective contraceptive methods from the signing of the informed consent to 90 days after the last administration of the study drug. Fertile female subjects must have negative pregnancy test results within 7 days (inclusive) before administration.
•In addition, eligible patients in phase II part must meet the following criteria:
•Histologically or cytologically confirmed diagnosis of unresectable or metastatic advanced tumors of specific types: hepatocellular carcinoma, cholangiocarcinoma/gallbladder cancer (except carcinoma of ampulla), pancreatic cancer, colorectal cancer, urothelium carcinoma, cervical cancer, head and neck squamous cell carcinoma, esophageal cancer and nasopharyngeal carcinoma.
•At least one measurable lesion (according to RECIST 1.1).

Exclusion Criteria

•Impaired cardiac function or clinically significant cardiac diseases.
•With acute or chronic infections.
•With active central nervous system metastases, including symptomatic brain metastases, meningeal metastases, spinal cord compression, or requiring treatment with glucocorticoids, antiepileptic drugs, anticonvulsant drugs, or mannitol.
•With known active autoimmune diseases or a history of autoimmune diseases within 1 year prior to enrollment.
•With clinically significant gastrointestinal diseases.
•Uncontrollable or symptomatic ascites, pleural effusion or pericardial effusion.
•With previous or present interstitial pneumonia.
•With other uncontrolled systemic diseases, such as hypertension and diabetes.
•Diagnosed with other malignant tumors within 3 years prior to starting study drug, except for cured carcinoma in situ of cervix and skin basal cell carcinoma.
•With diseases requiring immunosuppressant therapy, or requiring prednisone \> 10 mg/day or equivalent dose of similar drugs during the study period.

Arms & Interventions

GFH018+Toripalimab

Patient will be dosed in GFH018 in combination with Toripalimab. In the PhaseIb part, the dose levels will be escalated following the Bayesian optimal interval (BOIN) design. In the Phase II part, patients will be assigned based on tumor type(s).

Intervention: GFH018