A Phase 1 Study of LNCB74 in Advanced Solid Tumors

Conditions

• Advanced or Metastatic Solid Tumors
• Biliary Tract Cancer
• Breast Cancer
• Endometrial Cancer
• Non-Small Cell Lung Cancer
• Ovarian Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• LNCB74 — DRUG
  LNCB74 is an antibody drug conjugate being evaluated as a potential treatment for participants with advanced solid tumors. Participants will receive LNCB74 into the vein (IV; intravenously) in 21-day dosing cycles. Participants will continue treatment in the absence of unacceptable toxicities and unequivocal disease progression.

Study Details

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.

Key Dates

Start date

Jan 7, 2025

Status verified

Dec 2025

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

145 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1 - Dose Escalation and Backfills
  Aim: Doses of LNCB74 will be escalated to determine the maximum tolerated dose (MTD), maximum administered dose (MAD) and/or recommended Phase 2 dose (RP2D). One or more dose levels will be backfilled for safety and additional biomarker data.
• Experimental: Part 2 - Dose Expansion / Optimization
  Aim: The objectives of the Part 2 Dose Expansion/Optimization are: i) to evaluate safety, tolerability, anti-tumor activity, and pharmacodynamics of LNCB74 in a more homogenous population and ii) characterize the minimally safe and effective dose in a particular tumor type and determine recommended Phase 2 dose(s) (RP2D).

Primary Outcome Measure

Evaluate the safety and tolerability of LNCB74 [ Time Frame: 24 months ]

Locations (14)

Find similar trials in Newport Beach, CA

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