A Study of GFH018 in Patients With Advanced Solid Tumors | NCT05051241 | Trialant
NCT05051241
Sponsor
Zhejiang Genfleet Therapeutics Co., Ltd.
Status
Completed
Last Update Posted
Mar 1, 2024Actual
Enrollment
50Actual
Phase
Phase 1
Conditions
Advanced Solid Tumor
Interventions
GFH018
Countries
China
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT05051241
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
GFH018X1101
Secondary IDs
Not provided
Brief Title
A Study of GFH018 in Patients With Advanced Solid Tumors
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
Acronym
Not provided
Organization
Genfleet Therapeutics (Shanghai) Inc.INDUSTRY
Status Module
Record Verification Date
Jul 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 30, 2019Actual
Primary Completion Date
Aug 11, 2022Actual
Completion Date
Aug 11, 2022Actual
First Submitted Date
Sep 2, 2021
First Submission Date that Met QC Criteria
Sep 9, 2021
First Posted Date
Sep 21, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Jul 6, 2023
Results First Submitted that Met QC Criteria
Feb 28, 2024
Results First Posted Date
Mar 1, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 28, 2024
Last Update Posted Date
Mar 1, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Zhejiang Genfleet Therapeutics Co., Ltd.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief 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.
Detailed Description
Not provided
Conditions Module
Conditions
Advanced Solid Tumor
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
50Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Dose escalation Cohort 1
Experimental
5 mg BID, 14d-on/14d-off
Drug: GFH018
Dose escalation Cohort 2
Experimental
10 mg BID, 14d-on/14d-off
Drug: GFH018
Dose escalation Cohort 3
Experimental
20 mg BID, 14d-on/14d-off
Drug: GFH018
Dose escalation Cohort 4
Experimental
30 mg BID, 14d-on/14d-off
Drug: GFH018
Dose escalation Cohort 5
Experimental
40 mg BID, 14d-on/14d-off
Drug: GFH018
Dose escalation Cohort 6
Experimental
50 mg BID, 14d-on/14d-off
Drug: GFH018
Dose escalation Cohort 7
Interventions
Name
Type
Description
Arm Group Labels
Other Names
GFH018
Drug
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.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Incidence of Dose-limiting Toxicity (DLT) Events
31 days after the first dose
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
The Dose Escalation was intended to identify the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of GFH018 with at least 3 participants evaluable for assessment of dose-limiting toxicity per dose level. Since the MTD was not reached, 85 mg BID, 14d-on/14d-off was chosen for evaluation in the Dose Expansion phase.
Recruitment Details
A total of 50 participants who met all inclusion and no exclusion criteria were enrolled at 5 centers in China. A total of 47 participants started the Dose Escalation phase and three participants in the Dose Expansion phase.
Participants in Cohort 2 received GFH018 10 mg BID, 14d-on/14d-off orally
OG002
Adverse Events Module
Frequency Threshold
5
Time Frame
Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
Description
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
Participants in Cohort 10 received GFH018 85 mg BID, 14d-on/14d-off orally
0
3
1
3
3
3
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected3 at risk
Hypoxia
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected3 at risk
Neoplasma progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected9 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected3 at risk
Abdominal pain
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected3 at risk
Intestinal obstruction
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected3 at risk
Pneumonia
Infections and infestations
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG0032 events1 affected7 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected3 at risk
Ascites
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG0032 events1 affected7 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected3 at risk
Oedema peripheral
General disorders
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected9 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected3 at risk
Cardio-respiratory arrest
Cardiac disorders
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected9 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected3 at risk
Proteinuira
Renal and urinary disorders
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected9 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected3 at risk
Haemoptysis
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected9 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected3 at risk
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG0032 events2 affected7 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected4 at risk
EG0062 events2 affected6 at risk
EG0073 events3 affected9 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected3 at risk
Proteinuria
Renal and urinary disorders
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected4 at risk
EG0033 events3 affected7 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected6 at risk
EG0071 events1 affected9 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected3 at risk
Anemia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0062 events2 affected6 at risk
EG0073 events3 affected9 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected3 at risk
Lymphocyte count decreased
Blood and lymphatic system disorders
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0072 events2 affected9 at risk
EG0082 events2 affected6 at risk
EG0090 events0 affected3 at risk
ALT increased
Investigations
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected4 at risk
EG0032 events2 affected7 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected9 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected3 at risk
Urine protein present
Investigations
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected4 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected9 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected3 at risk
GGT increased
Investigations
Systematic Assessment
EG0000 events0 affected4 at risk
EG0012 events2 affected3 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected6 at risk
EG0072 events2 affected9 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected3 at risk
ALP increased
Investigations
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected4 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected9 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected3 at risk
LDH increased
Investigations
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected4 at risk
EG0031 events1 affected7 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected9 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected3 at risk
White blood cell count decreased
Investigations
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0062 events2 affected6 at risk
EG0071 events1 affected9 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected3 at risk
Decreased appetite
Metabolism and nutrition disorders
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected9 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected3 at risk
Abdominal pain
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0072 events2 affected9 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected3 at risk
Abdominal distension
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected9 at risk
EG0081 events1 affected6 at risk
EG0091 events1 affected3 at risk
Headache
Nervous system disorders
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0072 events2 affected9 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected3 at risk
Electrocardiogram T wave abnormal
Investigations
Systematic Assessment
EG0003 events3 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected3 at risk
Blood glucose increased
Investigations
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected4 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected9 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected3 at risk
Sinus tachycardia
Investigations
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected4 at risk
EG0062 events2 affected6 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected3 at risk
Peripheral edema
General disorders
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected3 at risk
Amylase increased
Investigations
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected3 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
After the completion of the research, researchers can collaborate with the sponsoring party for publication. Researchers must commit not to submit any part of the data from this study for publication without prior approval from the sponsoring party.