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Trial Title:
A Study of 3HP-2827 in Treatment of Unresectable or Metastatic Solid Tumors With FGFR2 Alterations
NCT ID:
NCT06378593
Condition:
Solid Tumors With FGFR2 Alterations, Adult
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
3HP-2827
Description:
3HP-2827 will be administered orally once daily in 28-day cycles.
Arm group label:
Stage I - dose escalation
Arm group label:
Stage II - expansion
Summary:
The study is being conducted to evaluate the safety, tolerability, efficacy,
pharmacokinetics, and pharmacodynamics of 3HP-2827 in the treatment of unresectable or
metastatic solid tumors with FGFR2 alterations.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- The patient is willing and able to provide written informed consent and has the
ability to comply with the study protocol
- Men or women, age ≥ 18 years at the time of signing informed consent.
- Histologically or cytologically confirmed surgically unresectable, locally advanced,
metastatic solid tumor.
- ECOG score is 0 or 1.
- An expected survival of ≥ 12 weeks.
- Evaluable or measurable disease per RECIST v1.1.
- Adequate organ function, as measured by laboratory values.
Exclusion Criteria:
- Active brain metastases.
- Have other malignancies within the past 3 years.
- The toxicity from previous anti-tumor treatment has not recovered to ≤ grade 1.
- Clinically significant corneal or retinal disease/keratopathy.
- Clinically significant cardiovascular disorders.
- Failure to swallow, chronic diarrhea, or presence of other factors affecting drug
absorption.
- Known to be allergic to any study drug or any of its excipients.
- Assessed by the investigator to be unsuitable for participation in this study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Lin Shen, MD
Facility:
Name:
ZhongShan Hospital
Address:
City:
Shanghai
Zip:
200123
Country:
China
Status:
Recruiting
Contact:
Last name:
Jia Fan, MD
Start date:
June 17, 2024
Completion date:
June 16, 2028
Lead sponsor:
Agency:
3H (Suzhou) Pharmaceuticals Co., Ltd.
Agency class:
Industry
Source:
3H (Suzhou) Pharmaceuticals Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06378593
