A Phase 1, Open-label, Dose Escalation and Dose Expansion Study for LNCB74, a B7-H4 Targeted Antibody Drug Conjugate, as Monotherapy in Participants With Advanced Solid Tumors
NextCure, Inc.
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. The participant provides written informed consent 2. ≥ 18 years of age on day of signing informed consent. 3. Participant with histologically or cytologically confirmed diagnosis of advanced unresectable and/or metastatic solid tumors 4. A male participant must agree to use contraception and refrain from sperm donation or expecting to father a child 5. A female participant is eligible to participate if she is not pregnant, not breastfeeding, not a woman of childbearing potential 6. Have measurable disease per RECIST 1.1 as assessed by the local site investigator/radiolo…
Interventions
- DrugLNCB74
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.
Locations (14)
- Hoag Family Cancer InstituteNewport Beach, California
- St. Elizabeth HealthcareEdgewood, Kentucky
- Dana Farber Cancer InstituteBoston, Massachusetts
- Washington University, Siteman Cancer CenterSt Louis, Missouri
- John Theurer Cancer Ctr at Hackensack Univ. Med Ctr.Hackensack, New Jersey
- Roswell Park Comprehensive Cancer CenterBuffalo, New York