Protocol Summary

Protocol No.

137438 (NAV-1001)

Principal Investigator

Garrido-Laguna, Ignacio

Phase

I

Age Group

Adult

ClinicalTrials.Gov

NCT04528836 (Click to jump to clinicaltrials.gov)

Eligibility Detail

Contact

Title

A Phase I/I B First-in-Human Study of the SHP2 Inhibitor BBP-398 (formerly known as IACS-15509) in Patients with Advanced Solid Tumors

Objective

Primary Objective
* The primary objective of this study is 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 or metastatic solid tumors.
Secondary Objectives
The secondary objectives of the study are:
* to assess the preliminary anti-tumor activity of BBP-398, as defined by objective response rate (ORR, complete response + partial response rate) and duration of response (DoR) * to assess the pharmacokinetic (PK)_and pharmacodynamic (PD) profile of BBP-398
Exploratory Objectives
* The exploratory objective of the study is to assess biomarkers that correlate with response.

Applicable Disease Sites

Experimental Therapeutics

Participating Institutions

Huntsman Cancer Institute

Status

Open


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