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

NCT06143007 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: BB3008-ST-I-02
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

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.

Conditions

Advanced Solid Tumor

Keywords

BB3008; HPK1; First-in-Human; Dose Escalation

Outcome Measures

Primary Outcomes (2)

• Number of subjects with dose limiting toxicities (DLTs)

  To assess the safety and tolerability of BB3008 tablet as monotherapy in subjects with advanced solid tumors and to determine the maximum tolerated dose (MTD) of BB3008 tablet, and to provide a basis for determination of the recommended dose (RP2D) for Phase II clinical trials.

  Single dose to the end of Cycle 1 (each cycle is 21 days)

• Number of subjects with adverse events (AEs) and serious adverse events (SAEs)

  AEs and SAEs will be characterized by type, seriousness, relationship to study treatment, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] version 5.0) and timing.

  From screening (Day -28 to Day -1) through up to 12 months or until disease progression

Secondary Outcomes (8)

• Pharmacokinetic Assessments: Peak Plasma Concentration (Cmax)

  Day 1, Day 8, Day 15 and at the end of Cycle 1 (each cycle is 21 days)

• Pharmacokinetic Assessments: Time to Peak Concentration (Tmax)

  Day 1, Day 8, Day 15 and at the end of Cycle 1 (each cycle is 21 days)

• Pharmacokinetic Assessments: Area under the plasma concentration-time curve (AUC)

  Day 1, Day 8, Day 15 and at the end of Cycle 1 (each cycle is 21 days)

• Pharmacokinetic Assessments: Elimination half-life (t½)

  Day 1, Day 8, Day 15 and at the end of Cycle 1 (each cycle is 21 days)

• Objective response rate (ORR)

  From date of screening until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Study Arms (1)

BB3008 monotherapy

EXPERIMENTAL

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).

Drug: BB3008 tablet

Interventions

BB3008 tablet DRUG

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

Also known as: BB3008

BB3008 monotherapy

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Broadenbio Ltd., Co.: lead

Study Sites (2)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100005, China

Location

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

Study Officials

• Jing Huang, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 22, 2023
• Study Start: October 26, 2023
• Primary Completion: May 22, 2025
• Study Completion: April 1, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

CN (2)