A First-in-Human, Phase 1/2 Study of LAT010 in Patients With Advanced Solid Tumors (LIGHTSPEED-1)

Part of paid clinical trials in Margate, Florida.

Sponsor
Latticon Antibody Therapeutics, Inc
Study ID
NCT06277219
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LAT010 — DRUG
    LAT010 monotherapy
  • LAT010 + ICI — DRUG
    LAT010 combination with PD-1 inhibitor

Study Details

This is an open-label, multicenter, Phase 1/2, first-in-human (FIH), dose-escalation and cohort-expansion study of LAT010 to evaluate the safety, tolerability, immunogenicity, PK, PD, and antitumor activity in patients with advanced solid tumors. The study consists of 2 parts: Phase 1 dose-escalation and Phase 2 cohort expansion.

Key Dates

Start date
Jun 5, 2024
Status verified
Jul 2025
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 LAT010 Dose Escalation
    LAT010 monotherapy with ascending doses in patients with locally advanced or metastatic solid tumors. LAT010 will be administered in planned 7 dose cohorts to determine safety and RP2D. PD profile of LAT010 will also be characterized.
  • Experimental: Phase 2 LAT010 Dose Expansion
    LAT010 monotherapy at the RP2D and in combination with a PD-1 inhibitor in patients with selected tumor types. LAT010 will be administered at multiple dose levels based on the results of Phase 1. Antitumor activity and safety will be further evaluated.

Primary Outcome Measure

Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) (Phase 1) [ Time Frame: Up to 18 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
D&H Cancer Research CenterMargateFlorida33063-
Huntsman Cancer InstituteSalt Lake CityUtah84112-

Find similar trials in Margate, FL

By research site
D&H Cancer Research Center· Margate, FLHuntsman Cancer Institute· Salt Lake City, UT

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