This is an open-label, phase 1, dose escalation and dose expansion study to determine safety and tolerability, and to determine the maximum tolerated dose and / or recommended phase 2 dose of LNCB74 in participants with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
145
LNCB74 is an antibody drug conjugate being evaluated as a potential treatment for participants with advanced solid tumors. Participants will receive LNCB74 into the vein (IV; intravenously) in 21-day dosing cycles. Participants will continue treatment in the absence of unacceptable toxicities and unequivocal disease progression.
Hoag Family Cancer Institute
Newport Beach, California, United States
RECRUITINGSt. Elizabeth Healthcare
Edgewood, Kentucky, United States
Evaluate the safety and tolerability of LNCB74
Incidence of AEs, SAEs, AEs meeting protocol defined DLT criteria, AEs leading to discontinuation and death, and laboratory abnormalities per NCI CTCAE v5.0
Time frame: 24 months
Define a recommended Phase 2 dose (RP2D) of LNCB74
Maximum tolerated dose (MTD), maximum administered dose (MAD) and/or recommended Phase 2 dose (RP2D) of LNCB74
Time frame: Up to 24 months
Characterize the immunogenicity of LNCB74
Incidence of anti-drug antibodies to LNCB74
Time frame: 24 months
Objective Response Rate (ORR)
Objective Response Rate (ORR) per RECIST v1.1
Time frame: 24 months
Duration of Response (DOR)
Duration of response per RECIST v1.1
Time frame: 24 months
Disease Control Rate (DCR)
Disease control rate per RECIST v1.1
Time frame: 24 months
Progression Free Survival Rate (PFSR)
Progression Free Survival Rate per RECIST v1.1
Time frame: 6 months
Correlate B7-H4 Expression with Objective Response Rate (ORR)
To determine B7-H4 expression by immunohistochemistry in a central lab and correlate B7-H4 expression with Objective Response Rate (ORR)
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Dana Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGWashington University, Siteman Cancer Center
St Louis, Missouri, United States
RECRUITINGJohn Theurer Cancer Ctr at Hackensack Univ. Med Ctr.
Hackensack, New Jersey, United States
NOT_YET_RECRUITINGRoswell Park Comprehensive Cancer Center
Buffalo, New York, United States
RECRUITINGCleveland Clinic Taussig Cancer Institute
Cleveland, Ohio, United States
RECRUITINGSidney Kimmel Comprehensive Center at Jefferson
Philadelphia, Pennsylvania, United States
RECRUITINGUPMC
Pittsburgh, Pennsylvania, United States
RECRUITINGMD Anderson
Houston, Texas, United States
RECRUITING...and 4 more locations
Time frame: 24 months
Correlate B7-H4 Expression with Duration of Response (DOR)
To determine B7-H4 expression by immunohistochemistry in a central lab and correlate B7-H4 expression with Duration of Response (DOR)
Time frame: 24 months
Correlate B7-H4 Expression with Disease Control Rate (DCR)
To determine B7-H4 expression by immunohistochemistry in a central lab and correlate B7-H4 expression with Disease Control Rate (DCR)
Time frame: 24 months
Correlate B7-H4 Expression with Progression Free Survival (PFS)
To determine B7-H4 expression by immunohistochemistry in a central lab and correlate B7-H4 expression with Progression Free Survival (PFS)
Time frame: 24 months
Progression Free Survival (PFS)
Progression Free Survival per RECIST v1.1
Time frame: 24 months
Time to Peak Drug Concentration (Tmax) of LNCB74
To evaluate the Time to Peak Drug Concentration (Tmax) of LNCB74
Time frame: Cycle 1 Days 1, 3, 8 and 15; Cycle 3 Days 1, 3, 8 and 15; Day 1 of Cycles 2, 4, 5, 7 and 9
Area Under the Curve (AUC) of LNCB74
To evaluate the Area Under the Curve (AUC) of LNCB74
Time frame: Cycle 1 Days 1, 3, 8 and 15; Cycle 3 Days 1, 3, 8 and 15; Day 1 of Cycles 2, 4, 5, 7 and 9
Half-life (T1/2) of LNCB74
To evaluate the Half-life (T1/2) of LNCB74
Time frame: Cycle 1 Days 1, 3, 8 and 15; Cycle 3 Days 1, 3, 8 and 15; Day 1 of Cycles 2, 4, 5, 7 and 9
Maximum Serum Concentration (Cmax) of LNCB74
To evaluate the Maximum Serum Concentration (Cmax) of LNCB74
Time frame: Cycle 1 Days 1, 3, 8 and 15; Cycle 3 Days 1, 3, 8 and 15; Day 1 of Cycles 2, 4, 5, 7 and 9