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.
The participant provides written informed consent
≥ 18 years of age on day of signing informed consent.
Participant with histologically or cytologically confirmed diagnosis of advanced unresectable and/or metastatic solid tumors
A male participant must agree to use contraception and refrain from sperm donation or expecting to father a child
A WOCBP who has a positive serum pregnancy test (within 72 hours) prior to treatment.
Has received prior investigational agents within 4 weeks prior to treatment.
Has received anti-cancer chemotherapy (Immunotherapy (non-antibody-based therapy), retinoid therapy, hormonal therapy within 2 weeks prior to treatment.
Has received antibody-based anti-cancer therapy within 4 weeks prior to treatment.
Sequential
LNCB74
DrugLNCB74 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.
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
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
Characterize the immunogenicity of LNCB74
Incidence of anti-drug antibodies to LNCB74
Objective Response Rate (ORR)
Objective Response Rate (ORR) per RECIST v1.1
Duration of Response (DOR)
Duration of response per RECIST v1.1
Disease Control Rate (DCR)
Disease control rate per RECIST v1.1
Click on the lead sponsor to view all of their trials.
NextCure, Inc.
Lead sponsor
LigaChem Biosciences, Inc.
Collaborator
