Actively Recruiting
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
Led by NextCure, Inc. · Updated on 2025-12-16
145
Participants Needed
14
Research Sites
N/A
Total Duration
On this page
Sponsors
N
NextCure, Inc.
Lead Sponsor
L
LigaChem Biosciences, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating LNCB74, an antibody drug conjugate, in participants with advanced solid tumors including ovarian, breast, endometrial, biliary tract, and non-small cell lung cancers. This phase 1, open-label study aims to determine the safety, tolerability, and the recommended dose for future studies by escalating doses and expanding treatment in selected tumor types. The study is sponsored by NextCure, Inc. and focuses on participants with measurable disease and adequate organ function. Participants will receive LNCB74 intravenously every 21 days in two parts: Part 1 involves dose escalation to find the maximum tolerated dose or recommended phase 2 dose, with additional safety and biomarker assessments. Part 2 involves dose expansion and optimization to further evaluate safety, tolerability, anti-tumor activity, and pharmacodynamics in a more uniform group of participants. Treatment continues unless unacceptable side effects or clear disease progression occur. During the study, participants will undergo regular safety and response evaluations including tumor assessments, biomarker analysis, and pharmacokinetic measurements. Key outcomes include safety, tolerability, response rates, and progression-free survival over up to 24 months. Blood samples will be taken to study drug levels and immune response. Participants are monitored closely for adverse effects and effectiveness, with a minimum life expectancy of 12 weeks required to join.
CONDITIONS
Brief Title
A Phase 1 Study of LNCB74 in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent
- Be 18 years of age or older
- Have a confirmed diagnosis of advanced unresectable and/or metastatic solid tumors
- Male participants must agree to use contraception and avoid sperm donation
- Female participants must not be pregnant, breastfeeding, or women of childbearing potential
- Have measurable disease per RECIST 1.1
- Able to provide tumor tissue sample
- Willing to undergo fresh tumor biopsy if archival tissue is unavailable
- Have an ECOG performance status of 0 to 1
- Life expectancy of at least 12 weeks as judged by investigator
- Have adequate organ function
You will not qualify if you...
- Women of childbearing potential with positive pregnancy test within 72 hours before treatment
- Received investigational agents within 4 weeks prior to treatment
- Received non-antibody cancer therapies within 2 weeks prior to treatment
- Received antibody-based cancer therapy within 4 weeks prior to treatment
- Received targeted agents or small molecules within 2 weeks or 5 half-lives, whichever is longer
- Received prior platinum-based chemotherapy and progressed within 4 weeks
- Received an antibody drug conjugate with MMAE payload
- Received radiotherapy within 2 weeks for focal or 4 weeks for wide-field prior to study
- Received G-CSF or GM-CSF within 7 days prior to study treatment
- Received live or live-attenuated vaccine within 30 days prior to first dose
- Have immunodeficiency or on systemic steroid/immunosuppressive therapy within 7 days prior
- Have active additional malignancy requiring treatment within past 3 years
- Have active CNS metastases or carcinomatous meningitis
- Have severe hypersensitivity (Grade 3 or higher) to LNCB74 or its components
- History or current pneumonitis or interstitial lung disease requiring steroids
- Active Grade 2 or higher sensory or motor neuropathy
- Active or chronic corneal or significant ocular disease requiring therapy
- Active infection requiring systemic treatment
- Major surgery within 4 weeks prior to study drug
- Toxicity from prior cancer therapy or surgery not resolved or Grade 1 or better
- Prior organ or tissue transplant
- Uncontrolled or significant cardiovascular disease
- Serious or uncontrolled medical disorders
- On total parenteral nutrition
- History of bowel obstruction within one month before screening
- Significant ascites needing paracentesis within 2 weeks before screening
- History of HIV with recent opportunistic infection or low CD4 count
- Active Hepatitis B or C infection
- Any condition or treatment interfering with study participation
- Known psychiatric or substance abuse disorder affecting cooperation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive LNCB74 intravenously in 21-day dosing cycles. Treatment continues in the absence of unacceptable toxicities and disease progression.
Repeated 21-day dosing cycles
Trial Site Locations
Total: 14 locations
1
Hoag Family Cancer Institute
Newport Beach, California, United States, 92663
Actively Recruiting
2
St. Elizabeth Healthcare
Edgewood, Kentucky, United States, 41017
Actively Recruiting
3
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
4
Washington University, Siteman Cancer Center
St Louis, Missouri, United States, 63108
Actively Recruiting
5
John Theurer Cancer Ctr at Hackensack Univ. Med Ctr.
Hackensack, New Jersey, United States, 07601
Not Yet Recruiting
6
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States, 14203
Actively Recruiting
7
Cleveland Clinic Taussig Cancer Institute
Cleveland, Ohio, United States, 44195
Actively Recruiting
8
Sidney Kimmel Comprehensive Center at Jefferson
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
9
UPMC
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
10
MD Anderson
Houston, Texas, United States, 77030
Actively Recruiting
11
NEXT Oncology
San Antonio, Texas, United States, 78229
Completed
12
UT Health San Antonio - MD Anderson Cancer Center
San Antonio, Texas, United States, 78229
Actively Recruiting
13
Intermountain/LDS Hospital Ph 1 Research Program
Salt Lake City, Utah, United States, 84143
Actively Recruiting
14
Inova Schar Cancer Institute
Falls Church, Virginia, United States, 22031
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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