Actively Recruiting
A Phase 1 Study of LNCB74 in Advanced Solid Tumors
Led by NextCure, Inc. · Updated on 2025-12-16
145
Participants Needed
14
Research Sites
99 weeks
Total Duration
On this page
Sponsors
N
NextCure, Inc.
Lead Sponsor
L
LigaChem Biosciences, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
- 18 years of age or older on the day of signing consent
- Diagnosis of advanced unresectable and/or metastatic solid tumors confirmed by histology or cytology
- Male participants must agree to use contraception and avoid sperm donation or fathering a child
- Female participants must not be pregnant, breastfeeding, or women of childbearing potential
- Measurable disease according to RECIST 1.1 criteria
- Able to provide tumor tissue sample
- Willing to undergo fresh tumor biopsy at screening and on-treatment if archival tissue is not available
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Life expectancy of at least 12 weeks as judged by the investigator
- Adequate organ function
You will not qualify if you...
- Women of childbearing potential with a positive serum pregnancy test within 72 hours prior to treatment
- Received prior investigational agents within 4 weeks before treatment
- Received non-antibody-based immunotherapy, retinoid therapy, or hormonal therapy within 2 weeks before treatment
- Received antibody-based anti-cancer therapy within 4 weeks before 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 (platinum-refractory disease)
- Received an antibody drug conjugate with MMAE payload
- Received radiotherapy within 2 weeks for focal radiation or 4 weeks for wide-field radiotherapy
- Received G-CSF or GM-CSF within 7 days before treatment
- Received a live or live-attenuated vaccine within 30 days before the first dose
- Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy exceeding 10 mg prednisone equivalent daily or other immunosuppressive therapy within 7 days before the first dose
- Known additional malignancy progressing or treated actively within the past 3 years
- Known active central nervous system metastases or carcinomatous meningitis
- Severe hypersensitivity (Grade 3 or higher), allergy, or reaction to LNCB74 or its excipients
- History of pneumonitis or interstitial lung disease requiring steroids or current pneumonitis/interstitial lung disease
- Active Grade 2 or higher sensory or motor neuropathy
- Active or chronic corneal disorders, other active ocular conditions requiring ongoing therapy, or significant corneal disease
- Active infection requiring systemic therapy
- Major surgery within 4 weeks of study drug administration
- Toxicity related to prior anti-cancer therapy or surgery not resolved, returned to baseline or Grade 1 unless irreversible
- Prior organ or tissue transplant
- Uncontrolled or significant cardiovascular disease
- Serious or uncontrolled medical disorders
- Receiving total parenteral nutrition
- History of bowel obstruction within 1 month of screening
- Significant ascites requiring paracentesis within 2 weeks of screening
- Known HIV infection with AIDS-defining infection within last year or current CD4 count below 350 cells/µl
- Known active Hepatitis B or Hepatitis C infection
- Any condition, therapy, lab abnormality, or circumstance interfering with study participation
- Known psychiatric or substance abuse disorder interfering with study cooperation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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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