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Testing LNCB74 in patients with advanced solid tumors

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

Phase 1 Interventional NextCure, Inc. · NCT06774963

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
Enrollment145 (estimated)
Ages18 Years and up
SexAll
SponsorNextCure, Inc. Industry-sponsored
Drugs / interventionschemotherapy, Immunotherapy, radiation, prednisone
Locations14 sites (Newport Beach, California and 13 other locations)
Trial IDNCT06774963 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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

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

Eligibility criteria

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 this trial is running

Newport Beach, California and 13 other locations

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ovarian CancerBreast CancerEndometrial CancerBiliary Tract CancerNon-Small Cell Lung CancerAdvanced or Metastatic Solid Tumors
Last reviewed 2026-06-09 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.