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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)

BBP-398 (formerly known as IACS-15509) is a potent, selective, orally active allosteric inhibitor of SHP2, a tyrosine phosphatase that plays a key role in the RTK -MAPK signal transduction pathway. Key components of the MAPK pathway include the small GTPase RAS, the serine/threonine-protein kinase RAF, mitogen-activated protein kinase (MEK) and ERK. In cells, SHP2 binds to phosphorylated tyrosine residues in the intracellular domain of RTKs such as the EGFR, leading to activation of the downstream MAPK signaling pathway.

BBP-398

Lei Mu, Master

Li Zhang, Master

Yongsheng Wang, Doctor

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.

The Part A of this phase I trial is an abbreviated dose escalation study of BBP-398 following the USA mono dose escalation study (Study NAV- 1001, clinicaltrials.gov ID NCT04528836). The purpose of this part is to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-cancer activity in Chinese subjects with advanced solid tumors. The Part B of this study is to explore the safety, tolerability and efficacy of BBP-398 in Chinese subjects with advanced or metastatic EGFR- mutant NSCLC at MTD and/or RP2D. This Phase I study will provide supportive data to enable Chinese patients to join the combo dose escalation and expansion studies and/or other clinical trials of BBP-398.

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

Anti-tumor activity will be defined by objective response rate (ORR, complete response + partial response rate) and duration of response (DOR) according to RECIST v1.1

Maximum plasma concentration of BBP-398 after single and multiple dose administration of BBP-398

The amount of time to reach Cmax after single and multiple dose administration of BBP-398

Terminal half-life (t1/2) after single and multiple dose administration of BBP-398

Area under the plasma concentration versus time curve after single and multiple dose administration of BBP-398

To evaluate BBP-398 excretion via urine after single and multiple dose administration of BBP-398.

To evaluate BBP-398 plasma concentration after multiple dose administration of BBP-398.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase I Study of the BBP-398 in Patients With Advance Solid Tumors	NCT05621525	Advanced Solid ... Advanced or Met...	BBP-398	18 Years - 99 Years	LianBio LLC
Phase I Study of the BBP-398 in Patients With Advance Solid Tumors	NCT05621525	Advanced Solid ... Advanced or Met...	BBP-398	18 Years - 99 Years	LianBio LLC
Phase I Study of the BBP-398 in Patients With Advance Solid Tumors	NCT05621525	Advanced Solid ... Advanced or Met...	BBP-398	18 Years - 99 Years	LianBio LLC

Spots Global Cancer Trial Database for solid tumors, nsclc