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
A Phase 1 Open-Label Study 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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
BL-M14D1 will be administered on D1 every 3 weeks.
Clearview Cancer Institute
Huntsville, Alabama, United States
NOT_YET_RECRUITINGValkyrie Clinical Trials
Los Angeles, California, United States
RECRUITINGUCLA
Los Angeles, California, United States
NOT_YET_RECRUITINGUCSF- San Francisco (Helen Diller Family Comprehensive Cancer Center)
San Francisco, California, United States
NOT_YET_RECRUITINGUniversity of Colorado - Anschutz Cancer Pavilion
Aurora, Colorado, United States
NOT_YET_RECRUITINGYale Cancer Center
New Haven, Connecticut, United States
RECRUITINGEmory Winship
Atlanta, Georgia, United States
RECRUITINGJohn Theurer Cancer Center-Hackensack
Hackensack, New Jersey, United States
RECRUITINGRutgers Cancer Institute
New Brunswick, New Jersey, United States
RECRUITINGIcahn School of Medicine at Mount Sinai
New York, New York, United States
RECRUITING...and 10 more locations
Assess safety and tolerability of BL-M14D1
SAEs, AESIs, TEAEs, death, TEAEs leading to discontinuation, DLTs, physical examination findings (including ECOG PS), vital sign measurements, standard clinical laboratory parameters, ECG parameters (including the change-from-baseline ECG parameters), and ECHO/MUGA findings
Time frame: 18 months
To characterize the PK of BL M14D1, total anti-DLL3 antibody, and payload (Ed-04)
PK Endpoints: Serum concentration of BL-M14D1, total anti-DLL3 antibody, and free payload ED-04 vs time will be utilized, serum PK parameters will include Cmax, Tmax, AUC0-8, AUClast and, if possible, Kel, t1/2, CL, Vz, Vss of BL-M14D1, total anti-DLL-3 antibody, and Ed-04. These PK parameters will be calculated both after the first dose and after multiple doses if applicable.
Time frame: 18 months
To investigate the antitumor activity of BL-M14D1
* Tumor response evaluated using RECIST v1.1, ORR, DCR, DoR, TTR, and PFS * OS
Time frame: 18 months
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