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

Phase 1

Recruiting

• Conditions: Advanced Solid Tumor
• Interventions: Drug: BB3008 tablet

• Registration Number: NCT06143007
• Lead Sponsor: BrodenBio Co., Ltd.

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.

Study Timeline

• Study Start: 2023-10-26
• Status Verified: 2023-11
• Study First Submitted: 2023-11-08
• Study First Submitted QC: 2023-11-19
• Last Update Submitted: 2023-11-19
• Study First Posted: 2023-11-22
• Last Update Posted: 2023-11-22
• Primary Completion: 2025-11
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
BB3008 monotherapy	BB3008 tablet	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).

Primary Outcome Measures

Name	Time	Method
Number of subjects with dose limiting toxicities (DLTs)	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.
Number of subjects with adverse events (AEs) and serious adverse events (SAEs)	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 Outcome Measures

Name	Time	Method
Pharmacokinetic Assessments: Elimination half-life (t½)	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
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)	Blood samples will be collected for PK analyses
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	Tumor response measured by radiologic imaging techniques at baseline and throughout the study.
Disease control rate (DCR)	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.
Progression-free survival (PFS)	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.
Pharmacokinetic Assessments: Peak Plasma Concentration (Cmax)	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
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)	Blood samples will be collected for PK analyses
Duration of response (DOR)	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.

Trial Locations

Locations (2)

Cancer Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China