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NCT Number: NCT06143007

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Advanced Solid Tumor

Age range

18 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cancer Hospital Chinese Academy of Medical Sciences, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

BB3008 tablet

Drug

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

Other names: BB3008

Primary outcomes

  1. Number of subjects with dose limiting toxicities (DLTs)

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

    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.

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

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

    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.

Secondary outcomes

  1. Pharmacokinetic Assessments: Peak Plasma Concentration (Cmax)

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

    Blood samples will be collected for PK analyses

  2. Pharmacokinetic Assessments: Time to Peak Concentration (Tmax)

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

    Blood samples will be collected for PK analyses

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

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

    Blood samples will be collected for PK analyses

  4. Pharmacokinetic Assessments: Elimination half-life (t½)

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

    Blood samples will be collected for PK analyses

  5. Objective response rate (ORR)

    Time frame: 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

    Tumor response measured by radiologic imaging techniques at baseline and throughout the study.

  6. Duration of response (DOR)

    Time frame: 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

    Tumor response measured by radiologic imaging techniques at baseline and throughout the study.

  7. Disease control rate (DCR)

    Time frame: 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

    Tumor response measured by radiologic imaging techniques at baseline and throughout the study.

  8. Progression-free survival (PFS)

    Time frame: 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

    Tumor response measured by radiologic imaging techniques at baseline and throughout the study.

Sponsors and collaborators

Lead sponsor

Broadenbio Ltd., Co.

Industry

Registry information

Official study title

A Phase I, Open-label, Multicenter Study to Assess Safety, Tolerability, Pharmacokinetic, Efficacy and Preliminary Food Effect of BB3008 Tablet Administered Orally to Patients With Advanced Solid Tumors

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Nov 22, 2023
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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