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).

Subjects are planned to be dosed in oral GFH018 tablets twice daily for a continuous 14 days in a 28 days cycle (7days on 7days off may be tested based on available data from phase I dose escalation study of single agent). the starting dose of GFH018 will be derived from the maximum safe dose explored in rom phase I dose escalation study of single agent.

GFH018

Subjects are planned to be dosed at 3 mg/kg Toripalimab as an intravenous infusion once every 2 weeks.

Toripalimab

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.

A Study of GFH018 in Combination With Toripalimab in Patients With Advanced Solid Tumors

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

Zhejiang Genfleet Therapeutics Co., Ltd.

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Pemetrexed

Cisplatin

Tubulin Modulators

Antimitotic Agents

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

GFH018 80mg 7-Day on/ 7-Day off and 4 doses of Toripalimab 240mg Q3W concurrently with standard chemo-radiotherapy, followed by GFH018 80mg 14-Day on/ 14-Day off and Toripalimab 3mg/kg Q2W for up to 48 weeks

Thoracic Radiation Therapy (TRT)

This is a phase II trial assessing the efficacy and safety of GFH018 and Toripalimab in combination with concurrent chemoradiotherapy (cCRT) in patients with unresectable, locally advanced, Stage III non-small cell lung cancer (NSCLC).

A Trial of GFH018 and Toripalimab in Combination With Concurrent Chemoradiotherapy in Stage III NSCLC Chemoradiotherapy in Stage III NSCLC

A Phase 2 Trial of GFH018 and Toripalimab in Combination With Concurrent Chemoradiotherapy for Patients With Unresectable, Locally Advanced Stage III Non-Small Cell Lung Cancer (NSCLC)

Objective response rate (ORR) is defined as the percentage of patients with objective response (OR).

OR was determined using the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). OR is defined as the best overall response (Complete Response (disappearance of all target and non-target lesions; no new lesions) or Partial Response (≥decrease in the sum of the largest diameters of target lesions; no new lesions)) across all assessment points from enrollment to termination of trial treatment. Radiological tumour assessment was performed using CT scans.

Subjects will receive GFH018 orally at different dose levels following twice daily, 14-day on/14-day off regimen. Other dose regimens, eg 7d-on/7d-off will also be considered to be explored when the safety/tolerability is confirmed.

Jin Li, MD

This is the first- in human study of GFH018 comprised of a dose escalation part and a dose expansion part in subjects with advanced solid tumors after single/multiple administration. The study is designed to explore the safety/tolerability, pharmacokinetics, and MTD of GFH018 and to define a RP2D of GFH018.

A Study of GFH018 in Patients With Advanced Solid Tumors

A Phase I Study With Single/Multiple Dose Administered to Explore the Safety/Tolerability and Pharmacokinetics of GFH018 in the Treatment of Patients With Advanced Solid Tumors

TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.

Participants in Cohort 1 received GFH018 5 mg BID, 14d-on/14d-off orally

Dose Escalation: Cohort 1 5 mg BID, 14d-on/14d-off

Participants in Cohort 2 received GFH018 10 mg BID, 14d-on/14d-off orally

Dose Escalation: Cohort 2 10 mg BID, 14d-on/14d-off

Participants in Cohort 3 received GFH018 10 mg BID, 14d-on/14d-off orally

Dose Escalation: Cohort 3 20 mg BID, 14d-on/14d-off

Participants in Cohort 4 received GFH018 30 mg BID, 14d-on/14d-off orally

Dose Escalation: Cohort 4 30 mg BID, 14d-on/14d-off

Participants in Cohort 5 received GFH018 40 mg BID, 14d-on/14d-off orally

Dose Escalation: Cohort 5 40 mg BID, 14d-on/14d-off

Participants in Cohort 6 received GFH018 50 mg BID, 14d-on/14d-off orally

Dose Escalation: Cohort 6 50 mg BID, 14d-on/14d-off

Participants in Cohort 7 received GFH01865 mg BID, 14d-on/14d-off orally

Dose Escalation: Cohort 7 65 mg BID, 14d-on/14d-off

Participants in Cohort 8 received GFH018 85 mg BID, 14d-on/14d-off orally

Dose Escalation: Cohort 8 85 mg BID, 14d-on/14d-off

Participants in Cohort 9 received GFH018 85 mg BID, 7d-on/17d-off orally

Dose Escalation: Cohort 9 85 mg BID, 7d-on/7d-off

Participants in Cohort 10 received GFH018 85 mg BID, 14d-on/14d-off orally

Dose Expansion: Cohort 10 85 mg BID, 14d-on/14d-off

Dose Escalation Cohort 1 5 mg BID, 14d-on/14d-off

Participants in Cohort 2 received GFH018 10 mg BID, 14d-on/14d-off

Participants in Cohort 3 received GFH018 20 mg BID, 14d-on/14d-off

Participants in Cohort 4 received GFH018 30 mg BID, 14d-on/14d-off

Participants in Cohort 5 received GFH018 40 mg BID, 14d-on/14d-off

Participants in Cohort 6 received GFH018 50 mg BID, 14d-on/14d-off

Participants in Cohort 7 received GFH018 65 mg BID, 14d-on/14d-off

Participants in Cohort 8 received GFH018 85 mg BID, 14d-on/14d-off

Participants in Cohort 9 received GFH018 85 mg BID, 7d-on/7d-off

Participants in Cohort 10 received GFH018 85 mg BID, 14d-on/14d-off

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

China

Region of Enrollment

Yuting Peng

Participants in Cohort 3 received GFH018 20 mg BID, 14d-on/14d-off orally

Participants in Cohort 7 received GFH018 65 mg BID, 14d-on/14d-off orally

Participants in Cohort 9 received GFH018 85 mg BID, 7d-on/7d-off orally

Participants enrolled in the expansion part were NOT included in analyzing the incidence of DLT. So the analyzed number of cohort 10 was 0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of GFH018 in Combination With Toripalimab in Patients With Advanced Solid Tumors	NCT04914286	Advanced Solid ...	GFH018 Toripalimab	18 Years - 75 Years	Genfleet Therapeutics (Shanghai) Inc.
A Trial of GFH018 and Toripalimab in Combination With Concurrent Chemoradiotherapy in Stage III NSCLC Chemoradiotherapy in Stage III NSCLC	NCT05386888	NSCLC, Stage II...	GFH018 Toripalimab Paclitaxel Carboplatin Cisplatin Pemetrexed Thoracic Radiat... GFH018	18 Years -	Genfleet Therapeutics (Shanghai) Inc.
A Study of GFH018 in Patients With Advanced Solid Tumors	NCT05051241	Advanced Solid ...	GFH018	18 Years - 75 Years	Genfleet Therapeutics (Shanghai) Inc.
A Study of GFH018 in Combination With Toripalimab in Patients With Advanced Solid Tumors	NCT04914286	Advanced Solid ...	GFH018 Toripalimab	18 Years - 75 Years	Genfleet Therapeutics (Shanghai) Inc.

Spots Global Cancer Trial Database for gfh018

Every month we try and update this database with for gfh018 cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for gfh018

Every month we try and update this database with for gfh018 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for gfh018 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.