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LNCB74-01NCT06774963

A Phase 1 Study of LNCB74 in Advanced Solid Tumors

StatusRecruiting
PhasePhase 1
Primary completion (estimated)

At risk: Primary completion moved at least 11 months later.

See at-risk trials from LigaChem Biosciences, Inc.

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Record History

All 6 versions: 6 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Dec 2026 to Dec 2027 Show 5 more changesShow less
    • Sponsor changed: NextCure, Inc. to LigaChem Biosciences, Inc.
    • Trial sites expanded: 14 → 17 locations
    • Eligibility criteria expanded, about 41 words
    • Secondary endpoints: details revised at 1 of 14 entries
    • Collaborator revised
  2. Site contacts updated at 1 of 14 sitesv5
  3. Study sites: 9 to 14v4
  4. Study sites: 4 to 9v3
  5. Study sites: 2 to 4
    • Start date changed from estimate of Jan 2025 to Jan 7, 2025
    v2
  6. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Evaluate the safety and tolerability of LNCB74
Timeframe: 24 months
Define a recommended Phase 2 dose (RP2D) of LNCB74
Timeframe: Up to 24 months

Secondary (14)

Characterize the immunogenicity of LNCB74
Objective Response Rate (ORR)
Duration of Response (DOR)
Disease Control Rate (DCR)
Progression Free Survival Rate (PFSR)
Show 9 moreShow less
Correlate B7-H4 Expression with Objective Response Rate (ORR)
Correlate B7-H4 Expression with Duration of Response (DOR)
Correlate B7-H4 Expression with Disease Control Rate (DCR)
Correlate B7-H4 Expression with Progression Free Survival (PFS)
Progression Free Survival (PFS)
Time to Peak Drug Concentration (Tmax) of LNCB74
Area Under the Curve (AUC) of LNCB74
Half-life (T1/2) of LNCB74
Maximum Serum Concentration (Cmax) of LNCB74

Arms and interventions

Part 1 - Dose Escalation and BackfillsExperimental

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.

Part 2 - Dose Expansion / OptimizationExperimental

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).

Drugs: LNCB74

Sites

17 sites in 1 country