A Phase 1 Study of LNCB74 in Advanced Solid Tumors

NCT06774963 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: LNCB74-01168703
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Ovarian Cancer; Breast Cancer; Endometrial Cancer; Biliary Tract Cancer; Non-Small Cell Lung Cancer; Advanced or Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Evaluate the safety and tolerability of LNCB74

  Incidence of AEs, SAEs, AEs meeting protocol defined DLT criteria, AEs leading to discontinuation and death, and laboratory abnormalities per NCI CTCAE v5.0

  24 months

• Define a recommended Phase 2 dose (RP2D) of LNCB74

  Maximum tolerated dose (MTD), maximum administered dose (MAD) and/or recommended Phase 2 dose (RP2D) of LNCB74

  Up to 24 months

Secondary Outcomes (14)

• Characterize the immunogenicity of LNCB74

  24 months

• Objective Response Rate (ORR)

  24 months

• Duration of Response (DOR)

  24 months

• Disease Control Rate (DCR)

  24 months

• Progression Free Survival Rate (PFSR)

  6 months

Study Arms (2)

Part 1 - Dose Escalation and Backfills

EXPERIMENTAL

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.

Drug: LNCB74

Part 2 - Dose Expansion / Optimization

EXPERIMENTAL

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).

Drug: LNCB74

Interventions

LNCB74 DRUG

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.

Part 1 - Dose Escalation and Backfills; Part 2 - Dose Expansion / Optimization

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• NextCure, Inc.: lead
• LigaChem Biosciences, Inc.: collaborator

Study Sites (14)

Hoag Family Cancer Institute

Newport Beach, California, 92663, United States

RECRUITING

St. Elizabeth Healthcare

Edgewood, Kentucky, 41017, United States

RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Washington University, Siteman Cancer Center

St Louis, Missouri, 63108, United States

RECRUITING

John Theurer Cancer Ctr at Hackensack Univ. Med Ctr.

Hackensack, New Jersey, 07601, United States

NOT YET RECRUITING

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14203, United States

RECRUITING

Cleveland Clinic Taussig Cancer Institute

Cleveland, Ohio, 44195, United States

RECRUITING

Sidney Kimmel Comprehensive Center at Jefferson

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

UPMC

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MD Anderson

Houston, Texas, 77030, United States

RECRUITING

NEXT Oncology

San Antonio, Texas, 78229, United States

COMPLETED

UT Health San Antonio - MD Anderson Cancer Center

San Antonio, Texas, 78229, United States

RECRUITING

Intermountain/LDS Hospital Ph 1 Research Program

Salt Lake City, Utah, 84143, United States

RECRUITING

Inova Schar Cancer Institute

Falls Church, Virginia, 22031, United States

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Breast Neoplasms; Endometrial Neoplasms; Biliary Tract Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Uterine Neoplasms; Uterine Diseases; Digestive System Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 14, 2025
• Study Start: January 7, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)