Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
SystImmune Inc.
Study ID
NCT06293898
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • BL-M07D1 — DRUG
    Drug: BL-M07D1 The study includes 3 parts: Part 1 Dose escalation. Part 2 Dose Finding non-randomized and Part 3 Dose expansion randomized. BL-M07D1 will be administered on Day 1 by intravenous infusion every 3 weeks. Other Names: BL-M07D1

Study Details

The objective of this study is to evaluate the safety, tolerability, and efficacy of BL-M07D1 in patients with HER2 expressing advanced tumors.

Key Dates

First listed
Mar 5, 2024
Start date
Feb 9, 2024
Status verified
Jul 2026
Primary completion
Dec 15, 2028
Completion
Apr 15, 2029

Study Design

Enrollment
280 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: Dose Escalation
    Beginning with Cycle 1, BL-M07D1 will be administered on Day 1 by (IV) infusion every 3 weeks (D1Q3W)
  • Experimental: Experimental: Dose Finding
    Beginning with Cycle 1, BL-M07D1 will be administered on Day 1 by (IV) infusion every 3 weeks (D1Q3W)
  • Experimental: Experimental: Dose Expansion
    Beginning with Cycle 1, BL-M07D1 will be administered on Day 1 by (IV) infusion every 3 weeks (D1Q3W)

Primary Outcome Measure

Summary of safety [ Time Frame: Though study completion, an average of 24 months ]

Central Contacts

Locations (17)

FacilityCityStateZIPSite coordinators
University of Alabama BirminghamBirminghamAlabama35294
Victoria Daiel
[email protected]
205-895-1729
Nusrat Jahan, MD (PRINCIPAL_INVESTIGATOR)
City of HopeDuarteCalifornia91010
Marianito (mark) Tuano
[email protected]
626-218-6585
Abhishek Tripathi, MD (PRINCIPAL_INVESTIGATOR)
Cedars SinaiLos AngelesCalifornia90211
Shannon Cyhan
[email protected]
301-248-7855
Jin Sun Bitar, MD (PRINCIPAL_INVESTIGATOR)
Scripps HealthSan DiegoCalifornia92121
Jackie Dexter
[email protected]
Wesleigh Edwards, MD (PRINCIPAL_INVESTIGATOR)
University of MiamiMiamiFlorida33136
Gilberto Lopes, MD (PRINCIPAL_INVESTIGATOR)
Sarah Cannon Research institute - Lake Nona FloridaOrlandoFlorida32827
Ingrid Acker
[email protected]
904-380-2414
Cesar Perez Batista, MD (PRINCIPAL_INVESTIGATOR)
Georgia Cancer Center at Augusta UniversityAugustaGeorgia30912
Donna Wheatley
[email protected]
Sharad Ghamande, MD (PRINCIPAL_INVESTIGATOR)
University of Chicago MedicineChicagoIllinois60637
Enya Meade
[email protected]
773-702-7871
Gini Fleming, MD (PRINCIPAL_INVESTIGATOR)
University of Illinois Cancer CenterChicagoIllinois60612
Omer Qazi
[email protected]
312-413-1069
Oana Danciu, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02215
Katherine (Katie) Lane
[email protected]
617-632-4792
Joyce Liu, MD (PRINCIPAL_INVESTIGATOR)
Karmanos Cancer InstitiuteDetroitMichigan48201
Wasif Saif, MD (PRINCIPAL_INVESTIGATOR)
NYU Langone Hospital - Long Island Investigational PharmacyMineolaNew York11501
Ying Lin
[email protected]
516-663-4895
Nancy Chan, MD (PRINCIPAL_INVESTIGATOR)
Laura & Isaac Perlmutter Cancer Center at NYU Langone HealthNew YorkNew York10016
Catia Neves
[email protected]
646-754-4403
Nancy Chan, MD (PRINCIPAL_INVESTIGATOR)
Providence Portland Medical CenterPortlandOregon97213
Anthony Sylvester
[email protected]
Rachel Sanborn, MD (PRINCIPAL_INVESTIGATOR)
Sarah Cannon Research InstituteNashvilleTennessee37203
Scott Miller
[email protected]
615-856-0995
Erica Hamilton, MD (PRINCIPAL_INVESTIGATOR)
Oncology ConsultantsHoustonTexas77030
Laura Guerra
713-600-0913
Julio Peguero, MD (PRINCIPAL_INVESTIGATOR)
Virginia Cancer SpecialistsFairfaxVirginia22031
Janice Alcaide
[email protected]
703-208-3771
Alexander Spira, MD (PRINCIPAL_INVESTIGATOR)

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