Advanced Solid TumorPhase 1/2NCT04914286
A Study of GFH018 in Combination With Toripalimab in Patients With Advanced Solid Tumors
A Phase 1/2 study testing GFH018 and Toripalimab in people with Advanced Solid Tumor, run by Genfleet Therapeutics (Shanghai) Inc. at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- GFH018 and Toripalimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 20 Oct 2021to 31 Dec 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
China2 sites
Sun Yat-sen university cancer center
Guangzhou, Guangdong
Shang hai east hospital
Shanghai, Shanghai Municipality
About this study
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
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.
- Conditions
- Advanced Solid Tumor
- Being tested
- GFH018, Toripalimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GFH018Drug
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.
ToripalimabDrug
Subjects are planned to be dosed at 3 mg/kg Toripalimab as an intravenous infusion once every 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| GFH018+Toripalimab | Experimental | 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). Receives: Drug: GFH018; Drug: Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Ib：Incidence of dose-limiting toxicity (DLT) events
Measured: 28 days
Phase II: ORR (Objective Response Rate)
Measured: approximately 6 months after first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start20 Oct 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by Genfleet Therapeutics (Shanghai) Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genfleet Therapeutics (Shanghai) Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914286
- Sponsor's protocol ID
- GFH018X0201
- Status last verified
- May 2025
- First submitted
- 31 May 2021
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04914286
- Acronym / sponsor ID
- GFH018X0201
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Genfleet Therapeutics (Shanghai) Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 4 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GFH018+Toripalimab | Experimental | Drug: GFH018, Drug: ToripalimabPatient 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GFH018Subjects 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 | GFH018+Toripalimab |
| ToripalimabSubjects are planned to be dosed at 3 mg/kg Toripalimab as an intravenous infusion once every 2 weeks. | Drug | GFH018+Toripalimab |
Primary outcome
Phase Ib：Incidence of dose-limiting toxicity (DLT) events
Time frame: 28 days
Phase II: ORR (Objective Response Rate)
Time frame: approximately 6 months after first dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GFH018 and Toripalimab in people with Advanced Solid Tumor, run by Genfleet Therapeutics (Shanghai) Inc. at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase Ib：Incidence of dose-limiting toxicity (DLT) events (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.