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

Advanced Solid Tumor Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06143007
• Other study ID #: BB3008-ST-?-02
• Status: Recruiting
• Phase: Phase 1
• Start date: October 26, 2023
• Est. completion date: April 2026

Study information

• Verified date: November 2023
• Source: BrodenBio Co., Ltd.
• Contact: Qi Wang, PhD
• Phone: +86-15311443674
• Email: qi.wang[@]broadenbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: April 2026
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 78 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• BB3008 tablet
BB3008 tablets will be administered orally once daily (QD).

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
BrodenBio Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Pharmacokinetic Assessments: Peak Plasma Concentration (Cmax)	Blood samples will be collected for PK analyses	Day 1, Day 8, Day 15 and at the end of Cycle 1 (each cycle is 21 days)
Secondary	Pharmacokinetic Assessments: Time to Peak Concentration (Tmax)	Blood samples will be collected for PK analyses	Day 1, Day 8, Day 15 and at the end of Cycle 1 (each cycle is 21 days)
Secondary	Pharmacokinetic Assessments: Area under the plasma concentration-time curve (AUC)	Blood samples will be collected for PK analyses	Day 1, Day 8, Day 15 and at the end of Cycle 1 (each cycle is 21 days)
Secondary	Pharmacokinetic Assessments: Elimination half-life (t½)	Blood samples will be collected for PK analyses	Day 1, Day 8, Day 15 and at the end of Cycle 1 (each cycle is 21 days)
Secondary	Objective response rate (ORR)	Tumor response measured by radiologic imaging techniques at baseline and throughout the study.	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
Secondary	Duration of response (DOR)	Tumor response measured by radiologic imaging techniques at baseline and throughout the study.	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
Secondary	Disease control rate (DCR)	Tumor response measured by radiologic imaging techniques at baseline and throughout the study.	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
Secondary	Progression-free survival (PFS)	Tumor response measured by radiologic imaging techniques at baseline and throughout the study.	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