RecruitingPhase 1

A Phase 1 Study of LNCB74 in 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests LNCB74 in adults with advanced solid tumors that cannot be removed by surgery or have spread. It checks safety and side effects and looks for the highest dose people can tolerate and a dose for future studies.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 years old and sign a written consent form.
  • Have an advanced solid tumor confirmed by a tissue or cell test that cannot be removed by surgery or has spread.
  • Have cancer that can be measured on scans.
  • Provide a tumor tissue sample. If stored tissue is not available, agree to have new samples taken before and during treatment.
  • Be fully active or able to do light work despite some limits on physical activity.
  • Be expected to live at least 12 weeks and have organs that work well enough.
  • Men must agree to use birth control, not donate sperm, and not plan to father a child.
  • Women must not be pregnant or breastfeeding and must not be able to become pregnant.

Who can't join

  • Have had certain cancer treatments, study drugs, radiation, medicines that boost white blood cells, or a live vaccine too recently. The waiting time depends on the treatment.
  • Have cancer that worsened within 4 weeks of starting platinum chemotherapy, or have ever received an antibody-linked cancer drug carrying MMAE.
  • Have another cancer that is growing or needed treatment in the past 3 years, or active cancer in the brain, spinal cord, or their lining.
  • Have a severe allergy to LNCB74 or its ingredients; certain lung inflammation, nerve damage, or eye problems; or serious or uncontrolled heart disease or other illness.
  • Have a weak immune system, recent treatment that lowers immune defenses, or an infection needing whole-body treatment. Certain HIV-related problems or active hepatitis B or C also exclude you.
  • Have had major surgery within 4 weeks, an organ or tissue transplant from another person, or lasting side effects from past cancer care that do not meet the study's allowed exceptions.
  • Get all nutrition through a vein, had a blocked bowel within the past month, or needed fluid drained from the belly within 2 weeks before screening.
  • Have a positive pregnancy blood test before treatment, or a health condition, mental health problem, substance use problem, treatment, or test result that could affect study results or your ability to take part.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (14)

CA

KY

MA

MO

NJ

NY

OH

PA

TX

UT

VA