New targeted drug LNCB74 enters human trials for Hard-to-Treat cancers
NCT ID NCT06774963
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 145 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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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Sign up to get updates when this study changes or when new studies for Advanced or metastatic solid tumors are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
13 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Locations
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Cleveland Clinic Taussig Cancer Institute
RECRUITINGCleveland, Ohio, 44195, United States
Contact Email: •••••@•••••
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Dana Farber Cancer Institute
RECRUITINGBoston, Massachusetts, 02215, United States
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Hoag Family Cancer Institute
RECRUITINGNewport Beach, California, 92663, United States
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Inova Schar Cancer Institute
RECRUITINGFalls Church, Virginia, 22031, United States
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Intermountain/LDS Hospital Ph 1 Research Program
RECRUITINGSalt Lake City, Utah, 84143, United States
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John Theurer Cancer Ctr at Hackensack Univ. Med Ctr.
NOT_YET_RECRUITINGHackensack, New Jersey, 07601, United States
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MD Anderson
RECRUITINGHouston, Texas, 77030, United States
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NEXT Oncology
COMPLETEDSan Antonio, Texas, 78229, United States
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Roswell Park Comprehensive Cancer Center
RECRUITINGBuffalo, New York, 14203, United States
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Sidney Kimmel Comprehensive Center at Jefferson
RECRUITINGPhiladelphia, Pennsylvania, 19107, United States
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St. Elizabeth Healthcare
RECRUITINGEdgewood, Kentucky, 41017, United States
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UPMC
RECRUITINGPittsburgh, Pennsylvania, 15213, United States
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UT Health San Antonio - MD Anderson Cancer Center
RECRUITINGSan Antonio, Texas, 78229, United States
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Washington University, Siteman Cancer Center
RECRUITINGSt Louis, Missouri, 63108, United States
Contact Email: •••••@•••••
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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