LNCB74-01 : 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

To evaluate the safety and tolerability of LNCB74. To determine the maximum tolerated dose (MTD), maximum administered dose (MAD) and/or recommended Phase 2 dose (RP2D) of LNCB74. 

For more information, visit: https://clinicaltrials.gov/study/NCT06774963

Inova Schar Cancer Institute
A division of Inova Fairfax Hospital
8081 Innovation Park Drive 
Fairfax, VA 22031

1) The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
2) Be ≥ 18 years of age on day of signing informed consent.
3) Participant with histologically or cytologically confirmed diagnosis. 

4) A male participant must agree to use contraception and refrain from sperm donation or expecting to father a child, from Screening through the treatment period and for at least 90 days after the last dose of study treatment.

5) A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:

1. Not a woman of childbearing potential (WOCBP)

2. A WOCBP who agrees to follow contraceptive guidance outlined from Screening through the treatment period and for at least 90 days after the last dose of study treatment. Life expectancy greater than or equal to 12 weeks as judged by the Investigator.

6)Have measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.

1)A WOCBP who has a positive serum pregnancy test (within 72 hours) prior to treatment.

2)Has severe hypersensitivity (≥ Grade 3), known allergy or reaction to LNCB74 or any of its excipients.

3) Has a history of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease.
4) Has active ≥Grade 2 sensory or motor neuropathy.

5)Prior organ or tissue allograft.

6)Participants with serious or uncontrolled medical disorders.

7)Has known active Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection.
Note: No testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.