Advanced Solid TumorPhase 1NCT05051241
A Study of GFH018 in Patients With Advanced Solid Tumors
A Phase 1 study testing GFH018 in people with Advanced Solid Tumor, run by Zhejiang Genfleet Therapeutics Co., Ltd. at 1 site in China.
Trial summary
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. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2019to 11 Aug 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Eligible subjects must meet all the inclusion criteria listed below:
- Voluntarily participate in this clinical trial and are willing to sign informed consent forms.
- Male or female aged from 18-75 years old (inclusive).
- Diagnosed with histologically or cytologically confirmed advanced solid tumors.
- Evaluable lesions defined by RECIST v1.1.
- Eastern Cooperative Oncology Group performance status of 0 to 1.
- Subjects or their legal representatives are able to communicate well with Investigators and are willing to comply with the protocol and complete the study.
Who cannot join
- Eligible subjects should not meet any of the exclusion criteria listed below:
- With clinically significant cardiac diseases.
- With clinically significant digestive disorders.
- Other severe disease.
- Pregnant or lactating women.
- Other unfavorable situations for subjects to participate in the study judged by Investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Advanced Solid Tumor
- Being tested
- GFH018
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GFH018Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation Cohort 1 | Experimental | 5 mg BID, 14d-on/14d-off Receives: Drug: GFH018 |
| Dose escalation Cohort 2 | Experimental | 10 mg BID, 14d-on/14d-off Receives: Drug: GFH018 |
| Dose escalation Cohort 3 | Experimental | 20 mg BID, 14d-on/14d-off Receives: Drug: GFH018 |
| Dose escalation Cohort 4 | Experimental | 30 mg BID, 14d-on/14d-off Receives: Drug: GFH018 |
| Dose escalation Cohort 5 | Experimental | 40 mg BID, 14d-on/14d-off Receives: Drug: GFH018 |
| Dose escalation Cohort 6 | Experimental | 50 mg BID, 14d-on/14d-off Receives: Drug: GFH018 |
| Dose escalation Cohort 7 | Experimental | 65 mg BID, 14d-on/14d-off Receives: Drug: GFH018 |
| Dose escalation Cohort 8 | Experimental | 85 mg BID, 14d-on/14d-off Receives: Drug: GFH018 |
| Dose escalation Cohort 9 | Experimental | 85 mg BID, 7d-on/7d-off Receives: Drug: GFH018 |
| Dose expansion Cohort 10 | Experimental | 85 mg BID, 14d-on/14d-off Receives: Drug: GFH018 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-limiting Toxicity (DLT) Events
Measured: 31 days after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start30 Aug 2019
- Primary completion11 Aug 2022
- Study completion11 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Genfleet Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jin Li, MD, Principal investigator, Leading site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05051241
- Sponsor's protocol ID
- GFH018X1101
- Status last verified
- Jul 2023
- First submitted
- 2 Sep 2021
- Last updated
- 1 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guo Y, Wang Z, Zhou H, Pan H, Han W, Deng Y, Li Q, Xue J, Ge X, Wang S, Wang J, Zhang Y, Zhao C, Zhu H, Wang Y, Shen H, Liu D, Li J. First-in-human study of GFH018, a small molecule inhibitor of transforming growth factor-beta receptor I inhibitor, in patients with advanced solid tumors. BMC Cancer. 2024 Apr 10;24(1):444. doi: 10.1186/s12885-024-12216-7.
PubMed 38600507
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05051241
- Acronym / sponsor ID
- GFH018X1101
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Zhejiang Genfleet Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Aug 2019 (actual)
- Primary completion
- 11 Aug 2022 (actual)
- Study completion
- 11 Aug 2022 (actual)
- First posted
- 21 Sep 2021 (actual)
- Results
- Posted 1 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Dose escalation Cohort 1 | Experimental | Drug: GFH0185 mg BID, 14d-on/14d-off |
| Dose escalation Cohort 2 | Experimental | Drug: GFH01810 mg BID, 14d-on/14d-off |
| Dose escalation Cohort 3 | Experimental | Drug: GFH01820 mg BID, 14d-on/14d-off |
| Dose escalation Cohort 4 | Experimental | Drug: GFH01830 mg BID, 14d-on/14d-off |
| Dose escalation Cohort 5 | Experimental | Drug: GFH01840 mg BID, 14d-on/14d-off |
| Dose escalation Cohort 6 | Experimental | Drug: GFH01850 mg BID, 14d-on/14d-off |
| Dose escalation Cohort 7 | Experimental | Drug: GFH01865 mg BID, 14d-on/14d-off |
| Dose escalation Cohort 8 | Experimental | Drug: GFH01885 mg BID, 14d-on/14d-off |
| Dose escalation Cohort 9 | Experimental | Drug: GFH01885 mg BID, 7d-on/7d-off |
| Dose expansion Cohort 10 | Experimental | Drug: GFH01885 mg BID, 14d-on/14d-off |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Eligible subjects must meet all the inclusion criteria listed below:
Key exclusion criteria (6 listed)
- Eligible subjects should not meet any of the exclusion criteria listed below:
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 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. | Drug | Dose escalation Cohort 1, Dose escalation Cohort 2, Dose escalation Cohort 3, Dose escalation Cohort 4, Dose escalation Cohort 5, Dose escalation Cohort 6, Dose escalation Cohort 7, Dose escalation Cohort 8, Dose escalation Cohort 9, Dose expansion Cohort 10 |
Primary outcome
Incidence of Dose-limiting Toxicity (DLT) Events
Time frame: 31 days after the first dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38600507Guo Y, Wang Z, Zhou H, Pan H, Han W, Deng Y, Li Q, Xue J, Ge X, Wang S, Wang J, Zhang Y, Zhao C, Zhu H, Wang Y, Shen H, Liu D, Li J. First-in-human study of GFH018, a small molecule inhibitor of transforming growth factor-beta receptor I inhibitor, in patients with advanced solid tumors. BMC Cancer. 2024 Apr 10;24(1):444. doi: 10.1186/s12885-024-12216-7.
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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.
Jin Li, MD principal investigator
Leading site
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GFH018 in people with Advanced Solid Tumor, run by Zhejiang Genfleet Therapeutics Co., Ltd. at 1 site in China.
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 7 inclusion and 6 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 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of Dose-limiting Toxicity (DLT) Events (time frame: 31 days after the first dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05051241, which also lists 1 linked publication.
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 1 Mar 2024.