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

NCT ID: NCT06143007

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-26
• Study Completion Date: 2026-04-30

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 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.

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BB3008 monotherapy

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).

Group Type: EXPERIMENTAL

BB3008 tablet

Intervention Type: DRUG

BB3008 tablets will be administered orally once daily (QD).

Interventions

BB3008 tablet

BB3008 tablets will be administered orally once daily (QD).

Intervention Type: DRUG

Other Intervention Names

BB3008

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 78 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Broadenbio Ltd., Co.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jing Huang, MD

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

BB3008-ST-I-02

Identifier Type: -

Identifier Source: org_study_id