Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors

Part of paid clinical trials in Beverly Hills, California.

Sponsor
SystImmune Inc.
Study ID
NCT05983432
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • BL-B01D1 — DRUG
    BL-B01D1 will be administered either on a Day 1 or Day 1 Day 8 dosing regimen

Study Details

The objective of this study is to evaluate the safety, tolerability, and efficacy of BL-B01D1 in patients with Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors.

Key Dates

Start date
Aug 8, 2023
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Mar 21, 2028

Study Design

Enrollment
470 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: BL-B01D1 administered Day 1 and Day 8 per cycle
    BL-B01D1 will be administered on Day 1 and Day 8 by intravenous infusion every 3 weeks
  • Experimental: BL-B01D1 administered Day 1 per cycle
    BL-B01D1 will be administered on Day 1 via by intravenous infusion every 3 weeks

Primary Outcome Measure

Participants with Dose-limiting toxicities [ Time Frame: One year ]

Central Contacts

Locations (24)

FacilityCityStateZIPSite coordinators
Beverly Hills Cancer CenterBeverly HillsCalifornia90211
Afshin Gabayan
[email protected]
Afshin Gabayan, MD (PRINCIPAL_INVESTIGATOR)
City of Hope Cancer CenterDuarteCalifornia91010
Adam Rock, MD (PRINCIPAL_INVESTIGATOR)
Chao Family Comprehensive Cancer Care and Ambulatory CareIrvineCalifornia92612
Cathleen Park, MD
Cathleen Park, MD (PRINCIPAL_INVESTIGATOR)
Chao Family Comprehensive Cancer Center and Ambulatory CareIrvineCalifornia92612
Cathleen Park
[email protected]
Cathleen Park, MD (PRINCIPAL_INVESTIGATOR)
University of California Irvine Medical CenterOrangeCalifornia92868
Cathleen Park
[email protected]
Cathleen Park, MD (PRINCIPAL_INVESTIGATOR)
UCLA Santa MonicaSanta MonicaCalifornia90404
Jonathan Goldman, MD
[email protected]
Jonathan Goldman, MD (PRINCIPAL_INVESTIGATOR)
University of Colorado Cancer CenterAuroraColorado80045
Tejas Patil, MD (PRINCIPAL_INVESTIGATOR)
Yale University, Yale Cancer CenterNew HavenConnecticut06520
Scott Gettinger
[email protected]
Scott Gettinger, MD (PRINCIPAL_INVESTIGATOR)
Georgetown University Medical CenterWashington D.C.District of Columbia20007
Stephen Liu, MD (PRINCIPAL_INVESTIGATOR)
Sylvester Comprehensive Cancer CenterMiamiFlorida33125
Gilberto Lopes
[email protected]
Gilberto Lopes, MD (PRINCIPAL_INVESTIGATOR)
Sara Cannon Research Institute Lake NonaOrlandoFlorida32827
Cesar Perez Batista
[email protected]
Cesar Perez Batista, MD (PRINCIPAL_INVESTIGATOR)
Hematology - Oncology Associates of the Treasure CoastPort Saint LucieFlorida34952
Nicholas Iannotti
[email protected]
Nicholas Iannotti, MD (PRINCIPAL_INVESTIGATOR)
Northwestern University Feinberg School of MedicineChicagoIllinois60611
Young Chae, MD (PRINCIPAL_INVESTIGATOR)
University of Iowa Hospital and ClinicsIowa CityIowa52242
Sneha Phadke
[email protected]
Sneha Phadke, MD (PRINCIPAL_INVESTIGATOR)
Norton Cancer InstituteLouisvilleKentucky40202
John Hamm, MD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
Janne Pasi, MD, PhD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Zofia Piotrowska
[email protected]
Zofia Piotrowska, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer Center Head Neck ServicesNew YorkNew York10065
Helena Yu, MD (PRINCIPAL_INVESTIGATOR)
PRISMA Health/ITORGreenvilleSouth Carolina29605
Jeffery Edenfield
[email protected]
Jeffery Edenfield, MD (PRINCIPAL_INVESTIGATOR)
Sarah Cannon - Tennessee OncologyNashvilleTennessee37203
Melissa Johnson
[email protected]
Melissa Johnson, MD (PRINCIPAL_INVESTIGATOR)
Oncology Consultants, P.A.HoustonTexas77030
Julio Peguero
[email protected]
Julio Peguero, MD (PRINCIPAL_INVESTIGATOR)
University of Texas M.D. Anderson Cancer CenterHoustonTexas77030
Xiuning Le, MD (PRINCIPAL_INVESTIGATOR)
Virginia Cancer SpecialistsFairfaxVirginia22031
Alexander Spira
[email protected]
Alexander Spira, MD (PRINCIPAL_INVESTIGATOR)
University of Washington Fred HutchinsonSeattleWashington98109
Christina Baik
[email protected]
Christina Baik, MD (PRINCIPAL_INVESTIGATOR)

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