Clinical trial

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

Name

LB1002-101

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.

Trial arms

Trial start

2022-10-18

Estimated PCD

2024-05-01

Trial end

2024-09-01

Status

Recruiting

Phase

Early phase I

Treatment

BBP-398

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.

Arms:

Part A Dose Escalation and Part B Dose Expansion

Other names:

IACS-15509

Size

Primary endpoint

Determination of Maximum Tolerated Dose (MTD) of BBP-398

Completion of 1 Cycle (28 days)

Determination of anti-tumor activity of BBP-398

Completion of 1 Cycle (28 days)

Eligibility criteria

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.

Protocol

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Updated at

2023-12-13

1 organization

1 product

2 indications

Product

Indication

Organization

Indication