Status:
RECRUITING
Phase I Study of HBT-708 for Patients With Advanced Solid Tumors
Lead Sponsor:
Shenyang Sunshine Pharmaceutical Co., LTD.
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The purpose of this study will be to evaluate the safety, tolerability, and inital efficacy of HBT-708 in subjects with advanced solid tumors.
Detailed Description
This study is a study of HBT-708 monotherapy in advanced solid tumors. This study includes dose-escalation and dose-expansion cohort, with the accelerated titration combined 3+3 dose escalation method...
Eligibility Criteria
Inclusion
- Male or female subjects, age 18 years or older.
- Histologically and/or cytologically documented advanced or measurable solid tumors.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Life expectancey \> = 3 months.
- Willingness to provide written informed consent for the study.
Exclusion
- Known uncontrolled or symptomatic central nervous system metastatic disease.
- Subjects must have recovered (≤ Grade 1 or pretherapy baseline) from AEs due to previously administered therapies. (National Cancer Institute Common terminology Criteria \[NCI CTCAE\] v.5.0).
- Inadequate organ or bone marrow function.
- Pregnant or breast-feeding woman.
- Known allergies, hypersensitivity, or intolerance to HBT-708 The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Key Trial Info
Start Date :
June 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 28 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06993870
Start Date
June 16 2025
End Date
June 28 2027
Last Update
July 11 2025
Active Locations (1)
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1
Shanghai General Hospital
Shanghai, Shanghai Municipality, China, 200000