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Virus Therapy

LAT010 for Solid Tumors (LIGHTSPEED-1 Trial)

Phase 1 & 2
Recruiting
Led By Benjamin L Maughan, MD
Research Sponsored by Latticon Antibody Therapeutics, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients are intolerant to or have progressed on all established standard therapies associated with clinical benefit or patients consent that they may be delaying or forgoing treatments known to confer a clinical benefit for their disease.
No additional established line of standard therapy is available.
Must not have
Patient is unwilling or unable to follow protocol requirements.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through treatment cycles in phase 2, up to approximately 1 year
Awards & highlights

Summary

This trial is testing a new drug called LAT010 in patients with advanced solid tumors. It is being done at multiple centers and has two parts: one to find the right dose and another to see how

Who is the study for?
This trial is for patients with advanced solid tumors who have not responded to standard treatments. It's a first-in-human study, meaning it's the first time this treatment is being tested in people. Participants must be adults with measurable disease and acceptable organ function.
What is being tested?
The trial is testing LAT010 alone and in combination with an immune checkpoint inhibitor (ICI) to see how safe they are and how well they work against tumors. The study has two parts: early testing of different doses (Phase 1) followed by expansion to more patients at selected dose levels (Phase 2).
What are the potential side effects?
As this is a first-in-human study, specific side effects of LAT010 are unknown but may include typical reactions seen with cancer therapies such as fatigue, nausea, inflammation-related symptoms, or immune system reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've tried all standard treatments without success or chosen to skip them.
Select...
There are no standard treatments left for my condition.
Select...
My cancer is advanced or has spread, and tests show it's getting worse.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am willing and able to follow the study's requirements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through treatment cycles in phase 2, up to approximately 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through treatment cycles in phase 2, up to approximately 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of changes in clinical laboratory values (Phase 1)
Incidence of dose-limiting toxicities (DLTs) (Phase 1)
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) (Phase 1)
+1 more
Secondary outcome measures
ADA occurrence and titer in serum
Area under the plasma concentration-time curve (AUC) of LAT010
Clearance of LAT010
+11 more
Other outcome measures
Epigenetic assessment of the proliferation and activation of CD4+ Treg cells, CD8+ T cells, and natural killer (NK) cells.
Optional flow cytometry assessment of the proliferation and activation of CD4+ Treg cells, CD8+ T cells, and NK cells.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Phase 2 LAT010 Dose ExpansionExperimental Treatment2 Interventions
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.
Group II: Phase 1 LAT010 Dose EscalationExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Latticon Antibody Therapeutics, IncLead Sponsor
John Li, PhDStudy ChairLatticon Antibody Therapeutics, Inc
Benjamin L Maughan, MDPrincipal InvestigatorHuntsman Cancer Institute
~100 spots leftby Dec 2026
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