Study of the CHK1 Inhibitor BBI-355, an ecDNA-directed Therapy (ecDTx), and the RNR Inhibitor BBI-825, in Subjects With Tumors With Oncogene Amplifications

Part of paid clinical trials in Los Angeles, California.

Sponsor
Boundless Bio, Inc.
Study ID
NCT05827614
Phase
PHASE1
Status
Terminated

Conditions

  • Anogenital Cancer
  • Cervical Squamous Cell Carcinoma
  • Cutaneous Squamous Cell Carcinoma (CSCC)
  • ER+ Breast Cancer
  • Head and Neck (HNSCC)
  • High Grade Endometrial Carcinoma
  • High Grade Serous Ovarian Carcinoma
  • Leiomyosarcoma (LMS)
  • Pancreatic Cancer Metastatic
  • Small Cell Lung Cancer
  • Triple Negative Breast Cancer (TNBC)
  • Undifferentiated Pleomorphic Sarcoma (UPS)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BBI-355 — DRUG
    Oral CHK1 inhibitor
  • Erlotinib — DRUG
    EGFR Inhibitor
  • Futibatinib — DRUG
    FGFR1-4 Inhibitor
  • BBI-825 — DRUG
    Oral RNR Inhibitor

Study Details

BBI-355 is an oral, potent, selective checkpoint kinase 1 (or CHK1) small molecule inhibitor in development as an ecDNA (extrachromosomal DNA) directed therapy (ecDTx). BBI-825 is an oral, potent, selective ribonucleotide reductase (or RNR) small molecule inhibitor. This is a first-in-human, open-label, 2-part, Phase 1/2 study to determine the safety profile and identify the maximum tolerated dose and recommended Phase 2 dose of BBI-355 administered as a single agent or in combination with BBI-825 or other select therapies.

Key Dates

First listed
Apr 25, 2023
Start date
Mar 24, 2023
Status verified
Jun 2026
Primary completion
Mar 17, 2026
Completion
Mar 17, 2026

Study Design

Enrollment
85 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Single Agent Dose Escalation
    Single agent BBI-355, administered orally in 28-day cycles
  • Experimental: Single Agent Dose Expansion
    Single agent BBI-355, administered orally in 28-day cycles
  • Experimental: Dose Escalation in Combination with EGFR Inhibitor
    Combination therapy of BBI-355 and EGFR inhibitor erlotinib, administered orally in 28-day cycles.
  • Experimental: Dose Escalation in Combination with FGFR Inhibitor
    Combination therapy of BBI-355 and FGFR1-4 inhibitor futibatinib, administered orally in 28-day cycles.
  • Experimental: Dose Escalation in Combination with RNR Inhibitor
    Combination therapy of BBI-355 and RNR Inhibitor BBI-825, administered orally in 28-day cycles.

Primary Outcome Measure

Frequency and severity of treatment emergent adverse events (TEAEs) of BBI-355 as a single agent and in combination with each of the following agents: erlotinib, futibatinib, or BBI-825 [ Time Frame: Start of Cycle 1 until 30 days following last dose (each cycle is 28 days) ]

Locations (16)

FacilityCityStateZIPSite coordinators
UCLA Medical CenterLos AngelesCalifornia90095-
Sarcoma OncologySanta MonicaCalifornia90403-
HealthONEDenverColorado80218-
Florida Cancer SpecialistsLake MaryFlorida32746-
The University of KansasFairwayKansas66205-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana Farber Cancer InstituteBostonMassachusetts02215-
START MidwestGrand RapidsMichigan49546-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
SCRI Oncology PartnersNashvilleTennessee37203-
MD Anderson Cancer CenterHoustonTexas77054-
NEXT Oncology - DallasIrvingTexas75039-
NEXT OncologySan AntonioTexas78229-
NEXT OncologyFairfaxVirginia22031-
University of Washington, Fred Hutchinson Cancer CenterSeattleWashington98109-
University of WisconsinMadisonWisconsin53792-

Find similar trials in Los Angeles, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
UCLA Medical Center· Los Angeles, CASarcoma Oncology· Santa Monica, CAHealthONE· Denver, COFlorida Cancer Specialists· Lake Mary, FLThe University of Kansas· Fairway, KSBeth Israel Deaconess Medical Center· Boston, MA

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