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

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 female participant is eligible to participate if she is not pregnant, not breastfeeding, not a woman of childbearing potential

• Have measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology

• Able to provide tumor tissue sample.

• Willing to undergo fresh tumor biopsy at Screening and On-treatment if archival tissue not available

• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

⁃ Life expectancy greater than or equal to 12 weeks as judged by the Investigator.

⁃ Have adequate organ function

Locations
United States
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
Missouri
Washington University, Siteman Cancer Center
RECRUITING
St Louis
New Jersey
John Theurer Cancer Ctr at Hackensack Univ. Med Ctr.
NOT_YET_RECRUITING
Hackensack
New York
Roswell Park Comprehensive Cancer Center
RECRUITING
Buffalo
Pennsylvania
UPMC
RECRUITING
Pittsburgh
Texas
MD Anderson
RECRUITING
Houston
NEXT Oncology
RECRUITING
San Antonio
UT Health San Antonio - MD Anderson Cancer Center
RECRUITING
San Antonio
Virginia
Inova Schar Cancer Institute
RECRUITING
Falls Church
Time Frame
Start Date: 2025-01-07
Estimated Completion Date: 2026-12
Participants
Target number of participants: 145
Treatments
Experimental: Part 1 - Dose Escalation and Backfills
Aim: Doses of LNCB74 will be escalated to determine the maximum tolerated dose (MTD), maximum administered dose (MAD) and/or recommended Phase 2 dose (RP2D). One or more dose levels will be backfilled for safety and additional biomarker data.
Experimental: Part 2 - Dose Expansion / Optimization
Aim: The objectives of the Part 2 Dose Expansion/Optimization are: i) to evaluate safety, tolerability, anti-tumor activity, and pharmacodynamics of LNCB74 in a more homogenous population and ii) characterize the minimally safe and effective dose in a particular tumor type and determine recommended Phase 2 dose(s) (RP2D).
Sponsors
Leads: NextCure, Inc.
Collaborators: LigaChem Biosciences, Inc.

This content was sourced from clinicaltrials.gov

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