Status:
ACTIVE_NOT_RECRUITING
A Phase 1 Study of BB3008 in Participants With Advanced Solid Tumors
Lead Sponsor:
Broadenbio Ltd., Co.
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18-78 years
Phase:
PHASE1
Brief Summary
This is a Phase 1 dose escalation study to evaluate the safety, tolerability, pharmacokinetics, efficacy and preliminary food effect of BB3008 as monotherapy in subjects with advanced solid tumors.
Detailed Description
This first-in-human (FIH) study of BB3008 will evaluate safety, tolerability, pharmacokinetics (PK) efficacy and preliminary food effect of BB3008 in subjects with advanced solid tumors. The primary o...
Eligibility Criteria
Inclusion
- Fully informed of the study and voluntarily signed the informed consent form (ICF), and willing to follow and have the ability to complete all trial procedures.
- Subjects with histologically or cytologically confirmed advanced solid tumors who are lacking standard therapy, progressing after adequate standard therapy, or intolerant of standard therapy.
- ECOG score ≤1.
- At least one evaluable or measurable lesion as defined by RECIST v1.1.
- Expected survival ≥ 3 months.
- adequate organ function.
- Female subjects of childbearing potential must have a negative pregnancy test prior to the first dose and are required to use effective contraception from signing the ICF until 6 months after the last dose of study treatment.
Exclusion
- History of dual-source cancer within 5 years.
- Presence of known active central nervous system (CNS) and/or leptomeningeal metastases.
- History of clinically serious cardiovascular and cerebrovascular disease within 6 months.
- Active infection (including, but not limited to HBV or HCV).
- Received radical radiotherapy within 12 weeks.
- Received live virus vaccination within 4 weeks.
Key Trial Info
Start Date :
October 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT06143007
Start Date
October 26 2023
End Date
April 1 2026
Last Update
November 17 2025
Active Locations (2)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100005
2
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021