Last reviewed · How we verify
NCT05621525
Phase I Study of the BBP-398 in Patients With Advance Solid Tumors
Phase 1 trial testing BBP-398 in Advanced Solid Tumor in 7 participants. Terminated before completion.
29 March 2024
Quick facts
| Lead sponsor | LianBio LLC |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 7 |
| Start date | 18 October 2022 |
| Primary completion | 29 March 2024 |
| Estimated completion | 29 March 2024 |
| Sites | 2 locations across China |
Drugs / interventions tested
- BBP-398 — full drug profile →
Conditions studied
- Advanced Solid Tumor — all drugs for Advanced Solid Tumor →
- Advanced or Metastatic Non-small Cell Lung Cancer — all drugs for Advanced or Metastatic Non-small Cell Lung Cancer →
Sponsor
LianBio LLC
Who can join
Adults 18 to 99, any sex, with Advanced Solid Tumor or Advanced or Metastatic Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Recent advances in targeting the "undruggable" proteins: from drug discovery to clinical trials.
Xie X, Yu T, Li X, Zhang N, et al · · 2023 · cited 246× · PMID 37669923 · DOI 10.1038/s41392-023-01589-z -
From bench to bedside: current development and emerging trend of KRAS-targeted therapy.
Chen Y, Liu QP, Xie H, Ding J. · · 2024 · cited 23× · PMID 38049578 · DOI 10.1038/s41401-023-01194-4 -
Tyrosine phosphatase <i>PTPN11/</i>SHP2 in solid tumors - bull's eye for targeted therapy?
Chen X, Keller SJ, Hafner P, Alrawashdeh AY, et al · · 2024 · cited 14× · PMID 38504984 · DOI 10.3389/fimmu.2024.1340726 -
Complex Roles of <i>PTPN11</i>/SHP2 in Carcinogenesis and Prospect of Targeting SHP2 in Cancer Therapy.
Scheiter A, Lu LC, Gao LH, Feng GS. · · 2024 · cited 10× · PMID 39959686 · DOI 10.1146/annurev-cancerbio-062722-013740 -
Protein tyrosine phosphatases: emerging role in cancer therapy resistance.
Zhao M, Shuai W, Su Z, Xu P, et al · · 2024 · cited 6× · PMID 38741380 · DOI 10.1002/cac2.12548 -
Targeting <i>KRAS</i> in pancreatic adenocarcinoma: Progress in demystifying the holy grail.
Elhariri A, Alhaj A, Ahn D, Sonbol MB, et al · · 2023 · cited 5× · PMID 37700806 · DOI 10.5306/wjco.v14.i8.285 -
Integrated Decision-Making in the Treatment of Colon-Rectal Cancer: The Case of KRAS-Mutated Tumors.
Cherri S, Melocchi L, Gandolfi L, Rossi G, et al · · 2023 · cited 3× · PMID 36836752 · DOI 10.3390/life13020395 -
Therapeutic potential of targeting protein tyrosine phosphatases in liver diseases.
Wang A, Zhang Y, Lv X, Liang G. · · 2024 · cited 2× · PMID 39220870 · DOI 10.1016/j.apsb.2024.05.006
Verify or expand the search:
- PubMed search for NCT05621525
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of BBP-398
Trials testing the same drug.
- NCT06032936 — BBP-398 in Combination With Osimertinib in Locally Advanced or Metastatic NSCLC Patients With EGFR Mutations · Phase 1 · terminated
- NCT05480865 — SHP2 Inhibitor BBP-398 in Combination With Sotorasib in Patients With Advanced Solid Tumors and a KRAS-G12C Mutation · Phase 1 · terminated
Other recruiting trials for Advanced Solid Tumor
Currently open trials in the same condition.
- NCT07300943 — Study in Advanced Solid Tumor Patients · Phase 1, PHASE2 · recruiting
- NCT07304128 — A Study of PLB-002 in Advanced Solid Tumors · Phase 1 · recruiting
- NCT07213830 — A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity · Phase 1, PHASE2 · recruiting
- NCT07226349 — A Study of BG-75098 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors · Phase 1 · recruiting
- NCT07222267 — An Investigational Study of BG-75202 Alone and in Combination With Other Therapeutic Agents in Adults With Advanced Soli · Phase 1 · recruiting
Other LianBio LLC trials
Trials by the same sponsor.
- NCT06206278 — Evaluation of Infigratinib in Patients With Locally Advanced or Metastatic Gastric Cancer or GEJ Adenocarcinoma · Phase 2 · terminated
- NCT06032936 — BBP-398 in Combination With Osimertinib in Locally Advanced or Metastatic NSCLC Patients With EGFR Mutations · Phase 1 · terminated
- NCT05629390 — Trial to Evaluate the Efficacy and Safety of TP-03, LIBRA Study · Phase 3 · completed
- NCT05174416 — A Study to Evaluate the Efficacy and Safety of Mavacamten in Chinese Adults With Symptomatic Obstructive HCM · Phase 3 · completed
- NCT05135871 — Study Evaluating the Pharmacokinetics of Mavacamten in Healthy Adult Chinese Subjects · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05621525 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by LianBio LLC
- Last refreshed: 25 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05621525.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing