Clinical trial Recruiting at 14 sites Phase 1 Interventional Ages 18 and up

Testing LNCB74 in patients with advanced solid tumors

Official title: 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

Run by LigaChem Biosciences, Inc. · NCT06774963 · Data updated 2026-11-12

This study is testing a new treatment called LNCB74 to see if it's safe and how well it works for people with advanced solid tumors like ovarian, breast, and lung cancer.

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment145 (estimated)
SponsorLigaChem Biosciences, Inc.
Industry-sponsored
Drugs / interventionschemotherapy, Immunotherapy, radiation, prednisone
Locations17 sites (Newport Beach, California and 16 other locations)
StatusRecruiting
StartedJanuary 7, 2025
Main results expectedDecember 2027
Study endsDecember 2027
Registry record updatedOctober 29, 2026
Trial IDNCT06774963 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older with advanced unresectable and/or metastatic solid tumors who can provide informed consent and meet specific health criteria.

Probably not a fit

Patients who are pregnant, breastfeeding, or have a positive pregnancy test will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, phase 1 study designed to evaluate the safety and tolerability of LNCB74 in patients with advanced solid tumors. The study will involve dose escalation and expansion to determine the maximum tolerated dose and/or recommended phase 2 dose. Participants will be required to provide tumor tissue samples and may undergo fresh tumor biopsies during the study. The focus is on patients with various types of advanced cancers, including ovarian, breast, endometrial, biliary tract, and non-small cell lung cancer.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors.

How similar studies have gone: Other studies have shown promise with similar approaches in targeting advanced solid tumors, indicating potential for success.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. The participant provides written informed consent
2. ≥ 18 years of age on day of signing informed consent.
3. Participant with histologically or cytologically confirmed diagnosis of advanced unresectable and/or metastatic solid tumors
4. A male participant must agree to use contraception and refrain from sperm donation or expecting to father a child
5. A female participant is eligible to participate if she is not pregnant, not breastfeeding, not a woman of childbearing potential
6. Have measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology
7. Able to provide tumor tissue sample.
8. Willing to undergo fresh tumor biopsy at Screening and On-treatment if archival tissue not available
9. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
10. Life expectancy greater than or equal to 12 weeks as judged by the Investigator.
11. Have adequate organ function

Exclusion Criteria:

1. A WOCBP who has a positive serum pregnancy test (within 72 hours) prior to treatment.
2. Has received prior investigational agents within 4 weeks prior to treatment.
3. Has received anti-cancer chemotherapy (Immunotherapy (non-antibody-based therapy), retinoid therapy, hormonal therapy within 2 weeks prior to treatment.
4. Has received antibody-based anti-cancer therapy within 4 weeks prior to treatment.
5. Has received targeted agents and small molecules within 2 weeks or 5 half-lives, whichever is longer.
6. Has received prior platinum-based chemotherapy and progressed within 4 weeks of initiating therapy (platinum-refractory disease)
7. Has received an ADC with MMAE payload.
8. Has received prior radiotherapy within 2 weeks of start of study treatment for focal radiation or within 4 weeks for wide-field radiotherapy
9. Has received G-CSF or GM-CSF within 7 days prior to start of study treatment.
10. Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention.
11. 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
12. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
13. Has known active CNS metastases and/or carcinomatous meningitis
14. Has severe hypersensitivity (≥ Grade 3), known allergy or reaction LNCB74 or any of its excipients.
15. Has a history of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease.
16. Has active ≥Grade 2 sensory or motor neuropathy.
17. Has active or chronic corneal disorders, other active ocular conditions requiring ongoing therapy or any clinically significant corneal disease.
18. Has an active infection requiring systemic therapy.
19. Any major surgery within 4 weeks of study drug administration.
20. 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.
21. Prior organ or tissue allograft.
22. Uncontrolled or significant cardiovascular disease
23. Participants with serious or uncontrolled medical disorders.
24. Participants who are on total parenteral nutrition (TPN)
25. Participants with history of bowel obstruction within one month of screening
26. Participants with history of significant ascites requiring paracentesis within 2 weeks of screening
27. Has a known history of human immunodeficiency virus (HIV) infection with an acquired immune deficiency syndrome (AIDS)-defining opportunistic infection within the last year, or a current CD4 count \<350 cells/µl
28. Has known active Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as HCV RNA \[qualitative\] is detected) infection
29. Has a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study
30. Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study

Where it's running

  • St. Elizabeth Healthcare
    Edgewood, Kentucky, United States
    Recruiting
  • Dana Farber Cancer Institute
    Boston, Massachusetts, United States
    Recruiting
  • Washington University, Siteman Cancer Center
    St Louis, Missouri, United States
    Recruiting
  • Roswell Park Comprehensive Cancer Center
    Buffalo, New York, United States
    Recruiting
  • Mount Sinai Tisch Cancer Center
    New York, New York, United States
    Recruiting
  • Memorial Sloan Kettering Cancer Center
    New York, New York, United States
    Recruiting
Show 11 more locations
  • Cleveland Clinic Taussig Cancer Institute
    Cleveland, Ohio, United States
    Recruiting
  • Sidney Kimmel Comprehensive Center at Jefferson
    Philadelphia, Pennsylvania, United States
    Recruiting
  • Upmc
    Pittsburgh, Pennsylvania, United States
    Recruiting
  • Sarah Cannon Research Institute
    Nashville, Tennessee, United States
    Recruiting
  • MD Anderson
    Houston, Texas, United States
    Recruiting
  • UT Health San Antonio - MD Anderson Cancer Center
    San Antonio, Texas, United States
    Recruiting
  • Intermountain/LDS Hospital Ph 1 Research Program
    Salt Lake City, Utah, United States
    Recruiting
  • Inova Schar Cancer Institute
    Falls Church, Virginia, United States
    Recruiting
  • Hoag Family Cancer Institute
    Newport Beach, California, United States
    Completed
  • John Theurer Cancer Ctr at Hackensack Univ. Med Ctr.
    Hackensack, New Jersey, United States
    Not yet recruiting
  • NEXT Oncology
    San Antonio, Texas, United States
    Completed

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  • Testing a new drug ETX-19477 for advanced solid tumors

    This study is testing a new drug called ETX-19477 to see if it can help people with advanced solid tumors that haven't responded to other treatments.

    Recruiting at 14 sites Phase 1/2 858 Therapeutics, Inc. · Phoenix, Arizona and 13 other locations · NCT06395519

  • Testing MGC026 in patients with advanced solid tumors

    This study is testing a new treatment called MGC026 to see if it can help adults with advanced solid tumors that can't be removed or have spread to other parts of the body.

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  • Testing MDX2001 for advanced solid tumors

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  • Evaluating PC14586 for advanced solid tumors with a specific mutation

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.