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New targeted drug LNCB74 enters human trials for Hard-to-Treat cancers

NCT ID NCT06774963

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This early-phase study tests a new drug, LNCB74, in people with advanced solid tumors (ovarian, breast, endometrial, bile duct, or lung cancer) that have not responded to standard treatments. The drug is designed to deliver a cancer-killing agent directly to tumor cells. The main goals are to find the safest dose and to see if it can shrink tumors. About 145 adults will take part.

Why investors are watching

NextCure is a micro-cap company, so this phase 1 trial of LNCB74 is a major test of its pipeline. The study tests whether the drug is safe and tolerable in people with advanced solid tumors, and it aims to find the right dose for later trials. A clear readout on safety and dosing will tell investors whether this drug has a future at the company.

If it works: If LNCB74 shows an acceptable safety profile and a recommended dose emerges, NextCure could advance the drug to later-stage testing. That progress could validate the company's research approach and support its value as a drug developer.

If it fails: Phase 1 trials often fail because the drug proves too toxic or does not behave as expected. A poor safety result or a delay in dosing decisions could set the program back and hurt the company's prospects, since it has few other assets to fall back on.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 145 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    13 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cleveland Clinic Taussig Cancer Institute

    RECRUITING

    Cleveland, Ohio, 44195, United States

    Contact Email: •••••@•••••

  • Dana Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Hoag Family Cancer Institute

    RECRUITING

    Newport Beach, California, 92663, United States

  • Inova Schar Cancer Institute

    RECRUITING

    Falls Church, Virginia, 22031, United States

  • Intermountain/LDS Hospital Ph 1 Research Program

    RECRUITING

    Salt Lake City, Utah, 84143, United States

  • John Theurer Cancer Ctr at Hackensack Univ. Med Ctr.

    NOT_YET_RECRUITING

    Hackensack, New Jersey, 07601, United States

  • MD Anderson

    RECRUITING

    Houston, Texas, 77030, United States

  • NEXT Oncology

    COMPLETED

    San Antonio, Texas, 78229, United States

  • Roswell Park Comprehensive Cancer Center

    RECRUITING

    Buffalo, New York, 14203, United States

  • Sidney Kimmel Comprehensive Center at Jefferson

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • St. Elizabeth Healthcare

    RECRUITING

    Edgewood, Kentucky, 41017, United States

  • UPMC

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • UT Health San Antonio - MD Anderson Cancer Center

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Washington University, Siteman Cancer Center

    RECRUITING

    St Louis, Missouri, 63108, United States

    Contact Email: •••••@•••••

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