Evaluating BL-M14D1 in Subjects With Locally Advanced or Metastatic Small Cell Lung Cancer and Neuroendocrine Tumors

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
SystImmune Inc.
Study ID
NCT07080242
Phase
PHASE1
Status
Recruiting
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Conditions

  • Locally Advanced Extrapulmonary Neuroendocrine Carcinoma
  • Locally Advanced Large Cell Neuroendocrine Carcinoma of the Lung
  • Locally Advanced Merkel Cell Carcinoma
  • Locally Advanced Neuroendocrine Prostate Cancer
  • Locally Advanced Poorly Differentiated Gastroenteropancreatic Neuroendocrine
  • Metastatic Advanced Merkel Cell Carcinoma
  • Metastatic Advanced Poorly Differentiated Gastroenteropancreatic Neuroendocrine Carcinoma
  • Metastatic Large Cell Neuroendocrine Carcinoma of the Lung
  • Metastatic Neuroendocrine Prostate Cancer
  • Neuroendocrine Cancer
  • Small Cell Lung Cancer Metastatic or Locally Advanced

Eligibility Criteria

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

Interventions

  • BL-M14D1 — DRUG
    BL-M14D1 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-M14D1 in Subjects with locally Advanced or Metastatic Small Cell Lung Cancer and Other Neuroendocrine Neoplasms

Key Dates

Start date
Apr 28, 2025
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

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

Arms

  • Experimental: Experimental BL-M14D1 administered Day 1 per cycle
    BL-M14D1 will be administered on Day 1 by intravenous (IV) infusion every 3 weeks

Primary Outcome Measure

Assess safety and tolerability of BL-M14D1 [ Time Frame: 18 months ]

Central Contacts

Locations (20)

FacilityCityStateZIPSite coordinators
Clearview Cancer InstituteHuntsvilleAlabama35805
Jorge Diaz, MD (PRINCIPAL_INVESTIGATOR)
UCLALos AngelesCalifornia90095
Jenna Davis
[email protected]
310-633-8400
Joel Hecht, MD (PRINCIPAL_INVESTIGATOR)
Valkyrie Clinical TrialsLos AngelesCalifornia90067
Trenis Palmer, PhD
[email protected]
912-398-3205
David Berz, MD, PhD, MPH (PRINCIPAL_INVESTIGATOR)
UCSF- San Francisco (Helen Diller Family Comprehensive Cancer Center)San FranciscoCalifornia94158
Rahul Aggarwal, MD (PRINCIPAL_INVESTIGATOR)
University of Colorado - Anschutz Cancer PavilionAuroraColorado80045
Melissa Cross, MPH
[email protected]
Tejas Patil, MD (PRINCIPAL_INVESTIGATOR)
Yale Cancer CenterNew HavenConnecticut06520-8028
Kwasi Boateng, M.S., CCRP
[email protected]
203-314-7948
Pamela Kunz, MD (PRINCIPAL_INVESTIGATOR)
Emory WinshipAtlantaGeorgia30322
Winship CTO
[email protected]
404-778-1868
Olatunji Alese, MD (PRINCIPAL_INVESTIGATOR)
John Theurer Cancer Center-HackensackHackensackNew Jersey07601
Oncology Clinical Research Referral Office
[email protected]
551-996-1777
Martin Gutierrez, MD (PRINCIPAL_INVESTIGATOR)
Rutgers Cancer InstituteNew BrunswickNew Jersey08901
Mohammad Ghalib, MBBS
[email protected]
732-609-2510
Sanjay Goel, MD (PRINCIPAL_INVESTIGATOR)
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Deborah Doroshow, MD (PRINCIPAL_INVESTIGATOR)
Ohio State UniversityColumbusOhio43201
Bhavana Konda, MD (PRINCIPAL_INVESTIGATOR)
Providence Cancer InstitutePortlandOregon97213
Kim Sutcliffe, RN
[email protected]
503-215-1979
Rachel Sanborn, MD (PRINCIPAL_INVESTIGATOR)
Prisma Health Cancer InstituteGreenvilleSouth Carolina29605
Jeffrey Edenfield, MD (PRINCIPAL_INVESTIGATOR)
NEXT DallasDallasTexas75039
Mofopefoluwa Akinwale
[email protected]
(972) 893-8800
Michael Song, MD, PhD, PharmD (PRINCIPAL_INVESTIGATOR)
START Dallas- Fort WorthDallasTexas76104
Henry Xiong, MD (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77030
Desirae Dufner
[email protected]
713-745-7813
Timothy Yap, MD (PRINCIPAL_INVESTIGATOR)
NEXT HoustonHoustonTexas77054
Emma Morales
[email protected]
832-384-7912
Jennifer Segar, MD (PRINCIPAL_INVESTIGATOR)
START- San AntonioSan AntonioTexas78229
Drew Rasco, MD (PRINCIPAL_INVESTIGATOR)
NEXT Oncology VirginiaFairfaxVirginia22031
Carrie Friedman, RN, BSN, OCN
[email protected]
703-636-1473
Alexander Spira (PRINCIPAL_INVESTIGATOR)
University of Washington/Fred Hutchinson Cancer CenterSeattleWashington98195
Samantha Kiriluk
[email protected]
206-606-7341
Shailender Bhatia, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Clearview Cancer Institute· Huntsville, ALUCLA· Los Angeles, CAValkyrie Clinical Trials· Los Angeles, CAUCSF- San Francisco (Helen Diller Family Comprehensive Cancer Center)· San Francisco, CAUniversity of Colorado - Anschutz Cancer Pavilion· Aurora, COYale Cancer Center· New Haven, CT

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