Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Solid Tumors

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
SystImmune Inc.
Study ID
NCT07021066
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Pancreatic Ductal Adenocarcinoma
  • Biliary Tract Cancer
  • Esophageal Adenocarcinoma
  • Gastric Adenocarcinoma
  • Other Solid Tumors

Eligibility Criteria

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

Interventions

  • BL-M05D1 — DRUG
    BL-M05D1 will be administered on D1 every 3 weeks.

Study Details

The objective of this study is to evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects with Advanced or Metastatic Solid Tumors.

Key Dates

Start date
Jul 30, 2025
Status verified
Apr 2026
Primary completion
Feb 28, 2027
Completion
May 31, 2027

Study Design

Enrollment
160 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental BL-M05D1 administered Day 1 per cycle
    BL-M05D1 will be administered on Day 1 by intravenous (IV) infusion every 3 weeks

Primary Outcome Measure

Participants with Dose-limiting toxicities [ Time Frame: 1 year ]

Central Contacts

Locations (17)

FacilityCityStateZIPSite coordinators
Mayo Clinic Cancer Center- PhoenixPhoenixArizona85054
Abby Strunce
[email protected]
Tainos Bekaii-Saab (PRINCIPAL_INVESTIGATOR)
HonorHealthScottsdaleArizona85266
Justin Price
[email protected]
Sierra McCarthy, BSN, RN
[email protected]
Sunil Sharma (PRINCIPAL_INVESTIGATOR)
University of Colorado HealthAuroraColorado80045
Katie Daniels
[email protected]
Sunnie Kim (PRINCIPAL_INVESTIGATOR)
Yale Cancer CenterNew HavenConnecticut06510
Maximilian Cedeno-Hahn
[email protected]
Michael Cecchini (PRINCIPAL_INVESTIGATOR)
Ochsner Medical CenterNew OrleansLouisiana70121
Ernestine Fisher
[email protected]
Jonathan Mizrahi (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArborMichigan48109
Susie Butler
[email protected]
Vaibhav Sahai (PRINCIPAL_INVESTIGATOR)
Karmanos Cancer InstituteDetroitMichigan48201
Wasif Saif (PRINCIPAL_INVESTIGATOR)
Hackensack University Medical CenterHackensackNew Jersey07601
Oncology Clinical Research Referral Office
[email protected]
551-996-1777
Martin Guiterrez, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Yaqubie Amin
[email protected]
Michael May (PRINCIPAL_INVESTIGATOR)
Sarah Cannon Research Institute - Oncology PartnersNashvilleTennessee37203
Meredith Pelster (PRINCIPAL_INVESTIGATOR)
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232
Rebekah Caza
[email protected]
Dana Cardin (PRINCIPAL_INVESTIGATOR)
NEXT Oncology- AustinAustinTexas78758
Heather Watson
[email protected]
Sheena Sahota (PRINCIPAL_INVESTIGATOR)
NEXT Oncology- DallasDallasTexas75039
Akinwale Mofopefoluwa
[email protected]
Michael Song (PRINCIPAL_INVESTIGATOR)
MD AndersonHoustonTexas77030
Jawana Phillips
[email protected]
Jaffer Ajani (PRINCIPAL_INVESTIGATOR)
NEXT Oncology San AntonioSan AntonioTexas78229
Jordan Georg
[email protected]
David Sommerhalder (PRINCIPAL_INVESTIGATOR)
START Center for Care Center- San AntonioSan AntonioTexas78229
Linda Rodriguez
[email protected]
Drew Rasco (PRINCIPAL_INVESTIGATOR)
Baylor Scott and White Medical Center- Temple ClinicTempleTexas76504
Karen Templeton
[email protected]
Lucas Wong (PRINCIPAL_INVESTIGATOR)

Find similar trials in Phoenix, AZ

By research site
Mayo Clinic Cancer Center- Phoenix· Phoenix, AZHonorHealth· Scottsdale, AZUniversity of Colorado Health· Aurora, COYale Cancer Center· New Haven, CTOchsner Medical Center· New Orleans, LAUniversity of Michigan· Ann Arbor, MI

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