A Phase 1 Study of LNCB74 in Advanced Solid Tumors

Recruiting now · Phase 1

Conditions studied: Ovarian Cancer, Breast Cancer, Endometrial Cancer, Biliary Tract Cancer, Non-Small Cell Lung Cancer, Advanced or Metastatic Solid Tumors

In brief

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.

Key facts

Study ID

NCT06774963

Run by

NextCure, Inc.

People needed

145

Starts

2025-01-07

Expected to finish

2026-12-01

Last updated by the study team

2025-12-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.
• Has received targeted agents and small molecules within 2 weeks or 5 half-lives, whichever is longer.
• Has received prior platinum-based chemotherapy and progressed within 4 weeks of initiating therapy (platinum-refractory disease)
• Has received an ADC with MMAE payload.
• Has received prior radiotherapy within 2 weeks of start of study treatment for focal radiation or within 4 weeks for wide-field radiotherapy
• Has received G-CSF or GM-CSF within 7 days prior to start of study treatment.
• Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention.
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug
• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
• Has known active CNS metastases and/or carcinomatous meningitis
• Has severe hypersensitivity (≥ Grade 3), known allergy or reaction LNCB74 or any of its excipients.
• Has a history of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease.
• Has active ≥Grade 2 sensory or motor neuropathy.
• Has active or chronic corneal disorders, other active ocular conditions requiring ongoing therapy or any clinically significant corneal disease.
• Has an active infection requiring systemic therapy.
• Any major surgery within 4 weeks of study drug administration.
• Toxicity (except for alopecia) related to prior anti-cancer therapy and/or surgery, unless the toxicity is either resolved, returned to baseline or Grade 1, or deemed irreversible.
• Prior organ or tissue allograft.
• Uncontrolled or significant cardiovascular disease
• Participants with serious or uncontrolled medical disorders.
• Participants who are on total parenteral nutrition (TPN)
• Participants with history of bowel obstruction within one month of screening

Where it is running

• Inova Schar Cancer Institute — Falls Church, Virginia, United States (enrolling)
• St. Elizabeth Healthcare — Edgewood, Kentucky, United States (enrolling)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Washington University, Siteman Cancer Center — St Louis, Missouri, United States (enrolling)
• Intermountain/LDS Hospital Ph 1 Research Program — Salt Lake City, Utah, United States (enrolling)
• Hoag Family Cancer Institute — Newport Beach, California, United States (enrolling)
• Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States (enrolling)
• Cleveland Clinic Taussig Cancer Institute — Cleveland, Ohio, United States (enrolling)
• Sidney Kimmel Comprehensive Center at Jefferson — Philadelphia, Pennsylvania, United States (enrolling)
• UPMC — Pittsburgh, Pennsylvania, United States (enrolling)
• MD Anderson — Houston, Texas, United States (enrolling)
• UT Health San Antonio - MD Anderson Cancer Center — San Antonio, Texas, United States (enrolling)
• John Theurer Cancer Ctr at Hackensack Univ. Med Ctr. — Hackensack, New Jersey, United States
• NEXT Oncology — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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