Clinical trial NCT06143007: A Phase 1 Study of BB3008 in Participants With Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumor
Keywords: BB3008
HPK1
First-in-Human
Dose Escalation
Lead sponsor: BrodenBio Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-11-22
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of subjects with dose limiting toxicities (DLTs)
timeFrame: Single dose to the end of Cycle 1 (each cycle is 21 days)
measure: Number of subjects with adverse events (AEs) and serious adverse events (SAEs)
timeFrame: From screening (Day -28 to Day -1) through up to 12 months or until disease progression
Secondary outcomes:
measure: Pharmacokinetic Assessments: Peak Plasma Concentration (Cmax)
timeFrame: Day 1, Day 8, Day 15 and at the end of Cycle 1 (each cycle is 21 days)
measure: Pharmacokinetic Assessments: Time to Peak Concentration (Tmax)
timeFrame: Day 1, Day 8, Day 15 and at the end of Cycle 1 (each cycle is 21 days)
measure: Pharmacokinetic Assessments: Area under the plasma concentration-time curve (AUC)
timeFrame: Day 1, Day 8, Day 15 and at the end of Cycle 1 (each cycle is 21 days)
measure: Pharmacokinetic Assessments: Elimination half-life (t½)
timeFrame: Day 1, Day 8, Day 15 and at the end of Cycle 1 (each cycle is 21 days)
measure: Objective response rate (ORR)
timeFrame: 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
measure: Duration of response (DOR)
timeFrame: 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
measure: Disease control rate (DCR)
timeFrame: 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
measure: Progression-free survival (PFS)
timeFrame: 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
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Jing Huang, MD
role: PRINCIPAL_INVESTIGATOR
References: