Dose Escalation Level 3 for Tumors, Solid

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
NEXT Oncology, Fairfax, VA
Tumors, Solid+3 More
BBP-398 with nivolumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a Phase 1 study of BBP-398, a SHP2 inhibitor, in combination with nivolumab, a PD-1 antibody, in patients with NSCLC with a KRAS mutation. The study involves 2 parts: Phase 1a Dose Escalation and Phase 1b Dose Expansion.

Eligible Conditions

  • Tumors, Solid
  • Non-Small Cell Lung Carcinoma (NSCLC)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: Completion of 1 Cycle (28 days)

Day 28
Assess preliminary antitumor activity of BBP-398 in combination with nivolumab
Phase 1a Dose Escalation: Assess safety, tolerability, and recommended phase 2 dose (RP2D) of BBP-398 in combination with nivolumab
Phase 1b Dose Expansion: Assess antitumor activity of BBP-398 in combination with nivolumab
Phase 1b Dose Expansion: Assess safety and tolerability of BBP-398 at the RP2D, in combination with nivolumab

Trial Safety

Trial Design

4 Treatment Groups

Dose Escalation Level 3
1 of 4
Dose Escalation Level 2
1 of 4
Dose Escalation Level 1
1 of 4
Dose Expansion
1 of 4
Experimental Treatment

45 Total Participants · 4 Treatment Groups

Primary Treatment: Dose Escalation Level 3 · No Placebo Group · Phase 1

Dose Escalation Level 3
Drug
Experimental Group · 1 Intervention: BBP-398 with nivolumab · Intervention Types: Drug
Dose Escalation Level 2
Drug
Experimental Group · 1 Intervention: BBP-398 with nivolumab · Intervention Types: Drug
Dose Escalation Level 1
Drug
Experimental Group · 1 Intervention: BBP-398 with nivolumab · Intervention Types: Drug
Dose Expansion
Drug
Experimental Group · 1 Intervention: BBP-398 with nivolumab · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: completion of 1 cycle (28 days)
Closest Location: NEXT Oncology · Fairfax, VA
Photo of NEXT Oncology Austin  1Photo of NEXT Oncology San Antonio  2Photo of NEXT Oncology Virginia  3
2019First Recorded Clinical Trial
26 TrialsResearching Tumors, Solid
23 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
Patients must have histologically documented, locally advanced and unresectable, or metastatic NSCLC with documentation of a KRAS mutation within the 1 year prior to screening.
Patients must have measurable disease by RECIST v1.1.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.