What is LAT010 studying for advanced solid tumors?

LAT010 is being studied to evaluate its safety, immune effects, how it is processed in the body, and its potential to fight advanced solid tumors. The trial aims to find appropriate dosing and assess preliminary tumor responses in patients who have limited treatment options. Latticon Antibody Therapeutics, Inc. is sponsoring this research to explore LAT010's potential as a cancer therapy.

Who may be eligible for this advanced solid tumor clinical trial?

Adults aged 18 years or older with locally advanced or metastatic solid tumors who have progressed on or cannot tolerate standard treatments may be eligible. Both men and women can join if they meet health requirements and have measurable tumors. Please review eligibility criteria for more details.

Is there any cost to participate in this advanced solid tumor clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. Personal travel and related expenses may vary and are not guaranteed to be covered. Participants can expect to receive treatment and monitoring without charge for study procedures.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years +

All Genders

ID06277219

Phase 12 Study of LAT010 Immunotherapy for Advanced Solid Tumors Evaluating Safety, Dosage, and Effectiveness

Led by Latticon Antibody Therapeutics, Inc · Updated on 2025-07-08

150

Participants Needed

Research Sites

12 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying LAT010, a new human IL-2 based immunocytokine, in patients with advanced solid tumors to assess its safety, immune response, how the body processes the drug, and its potential antitumor effects. This Phase 12, open-label, multicenter study aims to find an effective dose and evaluate initial efficacy in patients with cancers that have limited treatment options. LAT010 is designed to activate immune cells that fight tumors without causing some of the severe side effects seen with other IL-2 therapies. In Phase 1, patients with locally advanced or metastatic solid tumors will receive intravenous LAT010 once a week in 4-week cycles using a dose-escalation approach to find the maximum tolerated dose or recommended dose for Phase 2. Phase 2 will expand to include patients with specific tumor types receiving LAT010 alone or in combination with a PD-1 inhibitor at doses determined from Phase 1. The study includes up to seven dose groups in Phase 1 and multiple cohorts in Phase 2 to further evaluate safety and antitumor activity. Participants will undergo regular evaluations including lab tests, imaging scans, and monitoring for side effects throughout treatment cycles lasting up to 24 months or longer. Researchers will closely track adverse events, drug levels in the blood, immune responses, and tumor responses following RECIST 1.1 criteria. Safety follow-up will continue for up to 15 months after treatment to assess long-term effects. The total study duration includes initial dose finding and cohort expansion to better understand LAT010s potential in advanced cancer treatment.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Patients have voluntarily signed the informed consent.
Patients are willing and able to comply with study procedures including visits, treatment plans, and lab assessments.
Male or female aged 18 years or older.
Diagnosis of locally advanced or metastatic solid tumors with progressive disease per RECIST 1.1.
Patients have progressed on or are intolerant to all standard therapies, have no available standard therapy, or have contraindications for standard therapy.
At least one measurable tumor lesion by imaging.
Expected life expectancy greater than 12 weeks.
ECOG performance status 0 or 1 for Phase 1; 0 to 2 for Phase 2.
At least 4 weeks since prior major surgery.
Adequate pulmonary, cardiovascular, hematological, liver, and renal function.
No IL-2 therapy within 12 months before first LAT010 dose.
Specific lab values for blood counts, renal function, coagulation, and liver function within set limits.
Recovery from previous treatment toxicity to grade 1 or less except certain allowed toxicities.
Women of childbearing potential and sexually active men with partners of childbearing potential must use effective contraception during and for 90 days after study.
Negative pregnancy test for applicable female patients.
Male patients must not donate sperm from screening through 90 days after last dose.
For Phase 2: ability to undergo tumor biopsies or provide archived samples.
For Phase 2: histologically confirmed tumor type selected for study.
For Phase 2: received standard therapies for tumor type and consent to delay or forgo specific known beneficial treatments.
For Phase 2: no more than one prior line of anti-angiogenic therapy.

You will not qualify if you...

History of arterial thrombotic event, stroke, or transient ischemic attack within 6 months.
Symptomatic congestive heart failure (NYHA class III/IV) or uncontrolled significant cardiac arrhythmia.
Myocardial infarction or unstable angina within 6 months.
QTc prolongation over 480 ms on ECG.
Currently enrolled in another clinical study unless observational or follow-up only.
Use of systemic anti-cancer therapy within 3 weeks or 5 half-lives before first LAT010 dose.
Active untreated or unstable central nervous system metastases.
Another active primary malignancy untreated with curative intent, except certain skin or bladder cancers.
History of severe immune-related adverse events requiring prolonged corticosteroids.
Active infection requiring IV antibiotics within 7 days prior to dosing.
Active uncontrolled bleeding within 7 days prior to dosing.
Serious or non-healing wounds, fistulas, ulcers, or bone fractures within 7 days prior to dosing.
Live virus vaccine within 30 days prior to dosing (except inactivated flu or COVID-19 vaccines).
Known replicating HIV, active hepatitis B or C infection (exceptions for controlled or cured cases).
Use of corticosteroids over 10 mg/day prednisone or equivalent.
History of organ transplantation or systemic immunosuppressive therapy.
Positive SARS-CoV-2 test at screening.
Serious illness or medical condition unsuitable for study participation.
History of sensitivity or allergy to LAT010 or its components.
Any condition likely to interfere with consent, participation, or study results.
Breastfeeding or pregnant women.
Unwillingness or inability to follow protocol requirements.

Research Team

Lightspeed Study Contact

John Li, PhD

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Phase 12 Study of LAT010 Immunotherapy for Advanced Solid Tumors Evaluating Safety, Dosage, and Effectiveness

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria