- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04914286
A Study of GFH018 in Combination With Toripalimab in Patients With Advanced Solid Tumors
March 10, 2024 updated by: Zhejiang Genfleet Therapeutics Co., Ltd.
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
148
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jin Li
- Phone Number: +86 21 6882 1388
- Email: jli@genfleet.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.) ≤ 1. Subject with tumor involvement of the liver must have the Child-Pugh score of 0-7.
- 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.
- Subjects who have been treated with immunosuppressant drugs within 28 days prior to starting study drug, except for topical and inhaled cortisol and systemic cortisol of physiological dose (prednisone < 10 mg/day or equivalent dose of similar drugs).
- Subjects who have received live vaccine, attenuated vaccine within 28 days prior to starting study drug, or plans to receive live vaccine, attenuated vaccine during treatment or within 30 days after the last administration.
- Subjects who have been treated with radiotherapy, chemotherapy, targeted therapy, endocrine therapy, immunotherapy, and other anti-tumor therapies, or other investigational drugs within 5 half-life periods or within 28 days (whichever is shorter) prior to starting study drug.
- Subject who has received major surgeries (except for needle biopsy) that may affect the administration or study evaluation within 28 days prior to starting study drug.
- Subjects who have received strong inhibitor or inducer of CYP3A4, or herbal medicine/traditional Chinese medicines within 5 half-life periods or within 2 weeks (whichever is shorter) prior to starting study drug.
- Subjects who have received combined treatment of drugs targeting TGF-β and PD-(L)1, including combination of antibody and small molecule or bispecific antibody.
- Pregnant or lactating women.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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).
|
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.
Subjects are planned to be dosed at 3 mg/kg Toripalimab as an intravenous infusion once every 2 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Phase Ib:Incidence of dose-limiting toxicity (DLT) events
Time Frame: 28 days
|
28 days
|
Phase II: ORR (Objective Response Rate)
Time Frame: approximately 6 months after first dose
|
approximately 6 months after first dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 20, 2021
Primary Completion (Actual)
December 31, 2023
Study Completion (Actual)
December 31, 2023
Study Registration Dates
First Submitted
May 31, 2021
First Submitted That Met QC Criteria
May 31, 2021
First Posted (Actual)
June 4, 2021
Study Record Updates
Last Update Posted (Actual)
March 12, 2024
Last Update Submitted That Met QC Criteria
March 10, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GFH018X0201
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on GFH018
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Zhejiang Genfleet Therapeutics Co., Ltd.Completed
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Zhejiang Genfleet Therapeutics Co., Ltd.Active, not recruiting