Clinical trial
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
Name
GFH018X1101
Description
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.
Trial arms
Trial start
2019-08-30
Estimated PCD
2022-08-11
Trial end
2022-08-11
Status
Completed
Phase
Early phase I
Treatment
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.
Arms:
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
Size
50
Primary endpoint
Incidence of Dose-limiting Toxicity (DLT) Events
31 days after the first dose
Eligibility criteria
Inclusion Criteria:
* Eligible subjects must meet all the inclusion criteria listed below:
1. Voluntarily participate in this clinical trial and are willing to sign informed consent forms.
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:
* Eligible subjects should not meet any of the exclusion criteria listed below:
1. With clinically significant cardiac diseases.
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ACTUAL'}}
Updated at
2024-03-01
1 organization
1 product
1 abstract
1 indication
Organization
Zhejiang Genfleet TherapeuticsProduct
GFH018Indication
Advanced Solid TumorAbstract
GFH018, a small molecular inhibitor targeting TGF-βRI kinase, in patients with advanced solid tumors: final results of the phase I study.Org: Department of Medical Oncology, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China, The First Affiliated Hospital of Bengbu Medical College, Bengbu, China, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China, Department of Medical Oncology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China, Sixth Affiliated Hospital of Sun Yat-Sen University, Guangdong, China,