Testing BB3008 in patients with advanced solid tumors

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

This study is testing a new treatment called BB3008 in patients with advanced solid tumors to see how safe it is and how well it works.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years to 78 Years
• Sex: All
• Sponsor: BrodenBio Co., Ltd. (Industry-sponsored)
• Locations: 2 sites (Beijing, Beijing and 1 other locations)
• Trial ID: NCT06143007 on ClinicalTrials.gov

What this trial studies

This Phase 1 study evaluates the safety, tolerability, pharmacokinetics, and preliminary efficacy of BB3008, a new treatment for advanced solid tumors. Participants will receive BB3008 as a monotherapy, with the primary goal of determining the maximum tolerated dose and recommended phase II dose. The study will also assess the drug's pharmacokinetic profile, food effect, and explore potential biomarkers. This first-in-human trial aims to provide critical data on the drug's effects and safety in patients who have limited treatment options.

Who should consider this trial

Good fit: Ideal candidates include individuals with histologically confirmed advanced solid tumors who are either progressing after standard therapy or intolerant to it.

Not a fit: Patients with active central nervous system metastases or those with a history of dual-source cancer within the last five years may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced solid tumors who lack effective standard therapies.

How similar studies have performed: While this is a first-in-human study, similar approaches in targeting advanced solid tumors have shown promise in other trials.

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.

Where this trial is running

Beijing, Beijing and 1 other locations

• Peking Union Medical College Hospital — Beijing, Beijing, China (Not_yet_recruiting)
• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing, China (Recruiting)

Study contacts

• Principal investigator: Jing Huang, MD — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Study coordinator: Qi Wang, PhD

Conditions Advanced Solid Tumor; BB3008; HPK1; First-in-Human; Dose Escalation