Clinical trial · Interventional
A Phase 1 Study of BB3008 in Participants 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
NCT06143007CI-TRIAL-00097310active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BB3008 tablet | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BB3008 monotherapy
- description
- 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).
- interventionNames
- Drug: BB3008 tablet
Primary outcomes (2)
- measure
- Number of subjects with dose limiting toxicities (DLTs)
- timeFrame
- Single dose to the end of Cycle 1 (each cycle is 21 days)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 78 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.