A Phase 1 Study of BB3008 in Participants With Advanced Solid Tumors

• Status: Recruiting
• Trial end date: 2026-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BrodenBio Co., Ltd.

Criteria

Inclusion Criteria:

1. 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.

2. Subjects with histologically or cytologically confirmed advanced solid tumors who are lacking standard therapy, progressing after adequate standard therapy, or intolerant of standard therapy.

3. ECOG score ≤1.

4. At least one evaluable or measurable lesion as defined by RECIST v1.1.

5. Expected survival ≥ 3 months.

6. adequate organ function.

7. 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 Criteria:

1. History of dual-source cancer within 5 years.

2. Presence of known active central nervous system (CNS) and/or leptomeningeal metastases.

3. History of clinically serious cardiovascular and cerebrovascular disease within 6 months.

4. Active infection (including, but not limited to HBV or HCV).

5. Received radical radiotherapy within 12 weeks.

6. Received live virus vaccination within 4 weeks.