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SHP2 Inhibitor BBP-398 in Combination With Sotorasib in Patients With Advanced Solid Tumors and a KRAS-G12C Mutation

NCT05480865 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-12-12

No results posted yet for this study

Summary

This is a Phase 1 study of BBP-398, a SHP2 inhibitor, in combination with sotorasib, a KRAS-G12C inhibitor (KRAS-G12Ci), in patients with a KRAS-G12C mutation.

The study involves 2 parts: Phase 1a Dose Escalation and Phase 1b Dose Expansion/Optimization.

Conditions

  • Solid Tumor, Adult
  • Metastatic Solid Tumor
  • Metastatic NSCLC
  • Non Small Cell Lung Cancer

Interventions

DRUG

BBP-398

BBP-398 administered orally

DRUG

sotorasib

sotorasib administered orally

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Navire Pharma Inc., a BridgeBio company

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-06
Primary Completion
2024-08-22
Completion
2024-08-22
FDA Drug
Yes

Countries

  • Australia
  • Denmark
  • France
  • Greece
  • Italy
  • Netherlands
  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT05480865 on ClinicalTrials.gov