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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04914286
Recruitment Status : Recruiting
First Posted : June 4, 2021
Last Update Posted : February 1, 2022
Sponsor:
Information provided by (Responsible Party):
Genfleet Therapeutics (Shanghai) Inc. ( Zhejiang Genfleet Therapeutics Co., Ltd. )

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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: GFH018 Drug: Toripalimab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 195 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 20, 2021
Estimated Primary Completion Date : July 10, 2023
Estimated Study Completion Date : November 10, 2023

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).
Drug: GFH018
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.

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




Primary Outcome Measures :
  1. Phase Ib:Incidence of dose-limiting toxicity (DLT) events [ Time Frame: 28 days ]
  2. Phase II: ORR (Objective Response Rate) [ Time Frame: approximately 6 months after first dose ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Has histologically or cytologically confirmed diagnosis of advanced or metastatic solid tumors, progressed on at least first line therapy.
  2. Has sufficient organ functions.
  3. 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.
  4. Life expectancy≥12 weeks.
  5. 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:

  1. 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.
  2. At least one measurable lesion (according to RECIST 1.1).

Exclusion Criteria:

  1. Impaired cardiac function or clinically significant cardiac diseases.
  2. With acute or chronic infections.
  3. 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.
  4. With known active autoimmune diseases or a history of autoimmune diseases within 1 year prior to enrollment.
  5. With clinically significant gastrointestinal diseases.
  6. Uncontrollable or symptomatic ascites, pleural effusion or pericardial effusion.
  7. With previous or present interstitial pneumonia.
  8. With other uncontrolled systemic diseases, such as hypertension and diabetes.
  9. 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.
  10. With diseases requiring immunosuppressant therapy, or requiring prednisone > 10 mg/day or equivalent dose of similar drugs during the study period.
  11. 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).
  12. 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.
  13. 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.
  14. 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.
  15. 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.
  16. 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.
  17. Pregnant or lactating women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04914286


Contacts
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Contact: Jin Li +86 21 6882 1388 jli@genfleet.com

Locations
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Australia, Western Australia
Linear Clinical Research Ltd Recruiting
Perth, Western Australia, Australia
Contact: Michael Millward    0863825100    cancertrialsstartup@linear.org.au   
Sponsors and Collaborators
Zhejiang Genfleet Therapeutics Co., Ltd.
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Responsible Party: Zhejiang Genfleet Therapeutics Co., Ltd.
ClinicalTrials.gov Identifier: NCT04914286    
Other Study ID Numbers: GFH018X0201
First Posted: June 4, 2021    Key Record Dates
Last Update Posted: February 1, 2022
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms