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

Broadenbio Ltd., Co.

Status and phase: Active, not recruiting; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: BB3008 tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT06143007

BB3008-ST-I-02

Details and patient eligibility

About

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.

Full 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 objective is to determine the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) of BB3008 as monotherapy, and to evaluate the safety and tolerability of BB3008. The secondary objectives include the assessments of PK profile, preliminary efficacy, preliminary food effect (FE) and preliminary metabolites identification of BB3008. The exploratory objectives are to explore biomarkers and C-QTcF analysis.

Enrollment: 42 estimated patients

Sex: All

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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42 participants in 1 patient group

BB3008 monotherapy

Experimental group

Description:

The study is composed of fasted dose cohorts and fed dose cohort. BB3008 will be administered orally daily alone as monotherapy in all cohorts. In the fasted dose cohorts, the subjects will receive once daily of BB3008 monotherapy fasted across approximately 6 ascending dose levels. The starting dose is 80 mg/day. In the fed dose cohort, the subjects will receive once daily of BB3008 monotherapy in a fed condition. The dose selected for fed dose cohort must be deemed safe as assessed by safety monitoring committee (SMC).

Treatment:

Drug: BB3008 tablet