A Study of GFH018 in Patients With Advanced Solid Tumors
NCT ID: NCT05051241
Last Updated: 2024-03-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
50 participants
INTERVENTIONAL
2019-08-30
2022-08-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dose escalation Cohort 1
5 mg BID, 14d-on/14d-off
GFH018
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.
Dose escalation Cohort 2
10 mg BID, 14d-on/14d-off
GFH018
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.
Dose escalation Cohort 3
20 mg BID, 14d-on/14d-off
GFH018
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.
Dose escalation Cohort 4
30 mg BID, 14d-on/14d-off
GFH018
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.
Dose escalation Cohort 5
40 mg BID, 14d-on/14d-off
GFH018
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.
Dose escalation Cohort 6
50 mg BID, 14d-on/14d-off
GFH018
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.
Dose escalation Cohort 7
65 mg BID, 14d-on/14d-off
GFH018
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.
Dose escalation Cohort 8
85 mg BID, 14d-on/14d-off
GFH018
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.
Dose escalation Cohort 9
85 mg BID, 7d-on/7d-off
GFH018
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.
Dose expansion Cohort 10
85 mg BID, 14d-on/14d-off
GFH018
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.
Interventions
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GFH018
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.
Eligibility Criteria
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Inclusion Criteria
2. Male or female aged from 18-75 years old (inclusive).
3. Diagnosed with histologically or cytologically confirmed advanced solid tumors.
4. Evaluable lesions defined by RECIST v1.1.
5. Eastern Cooperative Oncology Group performance status of 0 to 1.
6. Subjects or their legal representatives are able to communicate well with Investigators and are willing to comply with the protocol and complete the study.
Exclusion Criteria
2. With clinically significant digestive disorders.
3. Other severe disease.
4. Pregnant or lactating women.
5. Other unfavorable situations for subjects to participate in the study judged by Investigators.
18 Years
75 Years
ALL
No
Sponsors
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Zhejiang Genfleet Therapeutics Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Jin Li, MD
Role: PRINCIPAL_INVESTIGATOR
Leading site
Locations
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Shanghai East hospital
Shanghai, , China
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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GFH018X1101
Identifier Type: -
Identifier Source: org_study_id
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