First-in-Human Study of the SHP2 Inhibitor BBP-398 in Patients With Advanced Solid Tumors

NCT04528836 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-12-12

No results posted yet for this study

Summary

A first-in-human study to evaluate the safety, tolerability and maximum tolerated dose (MTD) and establish the recommended phase 2 dose (RP2D) of BBP-398, a SHP2 inhibitor, in patients with advanced solid tumors.

Conditions

  • Tumor, Solid

Interventions

DRUG

BBP-398 (Formerly known as IACS-15509)

oral capsules

Sponsors & Collaborators

  • Navire Pharma Inc., a BridgeBio company

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-12
Primary Completion
2024-03-22
Completion
2024-07-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04528836 on ClinicalTrials.gov