Clinical trial · Interventional
Phase I Study of the BBP-398 in Patients With Advance Solid Tumors
A Phase I, Open Label, Dose Escalation and Expansion, Two- Part Study of SHP-2 Inhibitor BBP-398 to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-cancer Activity in Chinese Subjects With Advanced Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business reason
Summary
Brief summary (as posted)
This is an open label, dose escalation and expansion, two-part Phase I study for SHP-2 inhibitor BBP-398 to evaluate the safety, tolerability, pharmacokinetics, determine MTD and/or RP2D, and preliminary anti- cancer activity in Chinese subjects with advanced solid tumors and in Chinese subjects with advanced or metastatic EGFR-mutant NSCLC.
Conditions
Conditions (2)
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 or Metastatic Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | PROBABILISTIC | 0.70 |
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BBP-398 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Part A Dose Escalation and Part B Dose Expansion
- description
- Part A: Oral capsules taken in escalating levels to determine MTD/RP2D. Each treatment cycle will be 28 days in duration with BBP-398 administered, once daily (QD). Part B: Oral capsules administered at MTD/RP2D defined dose. Each treatment cycle will be 28 days in duration with BBP-398 administered, once daily (QD)
- interventionNames
- Drug: BBP-398
Primary outcomes (2)
- measure
- Determination of Maximum Tolerated Dose (MTD) of BBP-398
- timeFrame
- Completion of 1 Cycle (28 days)
- description
- The MTD will be based on DLT
- measure
- Determination of anti-tumor activity of BBP-398
- timeFrame
- Completion of 1 Cycle (28 days)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: 1\. Patients must have the ability to understand and the willingness to sign a written informed consent document 2 Patients must be willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other specified study procedures 3. Age ≥18, male or female 4.Dose escalation: locally advanced or metastatic solid tumors Dose expansion: Advanced or metastatic EGFR-mutant NSCLC 5. Patients must have measurable disease by RECIST v1.1. 6. Patients must have an ECOG performance status (PS) ≤2 7.Patients with a life expectancy of ≥12 weeks. 8. Patients must have adequate organ function Exclusion Criteria: 1. Patients with a known additional malignancy that is progressing or requires active treatment 2. Patients who have previously received a SHP-2 inhibitor 3. Patients who are hypersensitivity to SHP-2 inhibitor or any ingredients 4. Treatment with any of the related anti-cancer therapies prior to the first dose of BBP-398 within the stated timeframes 5. Patients with known active Hepatitis B, Hepatitis C infection, or HIV infection. 6. Patients with any of the cardiac-related issues or findings 7. Patients with a history of CVA, myocardial infarction or unstable angina within the previous 6 months before starting therapy. 8. Patients with known central nervous system (CNS) tumors 9. Patients with known active CNS metastases and/or carcinomatous meningitis. 10. Patients with persisting toxicity related to prior therapy. 11. Patients who have undergone major surgery within 4 weeks prior to study enrollment. 12. Pregnant or breastfeeding female patients. 13. Patients with inability to swallow oral medications or with gastrointestinal illness that would preclude the absorption of an oral agent.
References
Publications (0)
Data not yet available