To hear about similar clinical trials, please enter your email below
Trial Title:
A First-in-human Study of 3HP-2827 in Patients With Unresectable or Metastatic Solid Tumors With FGFR2 Alterations
NCT ID:
NCT06287918
Condition:
Solid Tumors With FGFR2 Alterations, Adult
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet 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. Patients will be enrolled in two stages:
dose escalation stage (Stage I) and expansion stage (Stage II).
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.
- Any other diseases or clinical laboratory, etc that may affect the interpretation of
the results, or renders the patients at high risk from treatment complications.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic
Address:
City:
Phoenix
Zip:
85054
Country:
United States
Facility:
Name:
The University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Start date:
June 2024
Completion date:
June 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/NCT06287918