NCT06714617 - Evaluate BL-M17D1 in Patients w/HER2-Expressing/Mutant Advanced or Metastatic Solid Tumors | Biotech Hunter

Enrollment

120

Participants

Timeline

Start Date

April 10, 2025

Primary Completion Date

September 1, 2027

Study Completion Date

December 1, 2027

Conditions

Breast Cancer Stage IIIHER2-positive Metastatic Breast CancerUnresectable Breast CarcinomaHer2-PositiveHER2 Gene MutationGastroesophageal-junction CancerNon Small Cell Lung CancerEndometrial NeoplasmsPeritoneal CancerFallopian Tube CancerOvarian CancerUrothelial Carcinoma BladderSolid Tumor, AdultGastric Cancer

Interventions

DRUG

BL-M17D1

The study includes 3 parts: Part 1 Dose escalation. Part 2 Dose Finding non-randomized and Part 3 Dose expansion randomized. BL-M17D1 will be administered on Day 1 and Day 8 by intravenous infusion every 3 weeks.

Trial Locations (12)

19107

RECRUITING

SCRI-Sidney Kimmel Cancer Center, Philadelphia

22031

RECRUITING

NEXT Oncology, Fairfax

32746

NOT_YET_RECRUITING

SCRI-Florida Cancer Center Specialists Lake Mary, Lake Mary

34236

NOT_YET_RECRUITING

SCRI-Florida Cancer Center Specialists Sarasota, Sarasota

34952

NOT_YET_RECRUITING

Hematology Oncology Associates of the Treasure Cost, Port Saint Lucie

37203

NOT_YET_RECRUITING

SCRI-Denver HealthOne, Denver

NOT_YET_RECRUITING

SCRI-Oncology Partners, Nashville

46202

NOT_YET_RECRUITING

Indiana University, Indianapolis

77030

NOT_YET_RECRUITING

MD Anderson Cancer Center, Houston

85234

NOT_YET_RECRUITING

Banner MD Anderson Cancer Center, Gilbert

06510

NOT_YET_RECRUITING

Yale Cancer Center, New Haven

02215

NOT_YET_RECRUITING

Dana-Farber Cancer Institute, Boston

All Listed Sponsors

lead

SystImmune Inc.

INDUSTRY