Actively Recruiting
A First-in-Human, Phase 1/2 Study of LAT010 in Patients With Advanced Solid Tumors (LIGHTSPEED-1)
Led by Latticon Antibody Therapeutics, Inc · Updated on 2025-07-08
150
Participants Needed
4
Research Sites
142 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A First-in-Human, Phase 1/2 Study of LAT010 in Patients With Advanced Solid Tumors (LIGHTSPEED-1)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be 18 years or older.
- Patients have a histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumors with progressive disease.
- Patients are intolerant to or have progressed on all standard therapies or have no standard therapy options.
- Patients have at least one measurable tumor lesion of 10 mm or larger by imaging or a pathological lymph node lesion of 15 mm or larger.
- Patients are expected to live longer than 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 for Phase 1; 0 to 2 for Phase 2.
- At least 4 weeks must have passed since any major surgery.
- Patients have adequate heart, lung, blood, liver, and kidney function.
- Patients have not received IL-2 therapy in the past 12 months.
- Laboratory values meet specified thresholds for blood counts, kidney function, coagulation, and liver enzymes.
- Any previous treatment toxicities have recovered to Grade 1 or less, except for certain mild conditions.
- Women of childbearing potential and sexually active men with partners of childbearing potential agree to use effective contraception during and for 90 days after treatment.
- Male patients must not donate sperm during the study and for 90 days after the last dose.
- For Phase 2, patients must be willing to undergo tumor biopsies and have received prior standard therapies including 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.
- History of symptomatic congestive heart failure class III or IV or uncontrolled significant cardiac arrhythmia.
- History of myocardial infarction or unstable angina within 6 months.
- QTc interval longer than 480 milliseconds on ECG.
- Currently enrolled in another interventional clinical study.
- Use of other systemic anti-cancer therapies within 3 weeks or 5 half-lives before first dose.
- Active central nervous system metastases unless treated and stable for at least 2 weeks.
- Active second primary malignancy not treated with curative intent, except some skin or bladder cancers.
- History of severe immune-related adverse events requiring prolonged corticosteroid treatment.
- Active infection requiring intravenous antibiotics within 7 days.
- Active uncontrolled bleeding or serious non-healing wounds within 7 days.
- Live virus vaccination within 30 days before first dose (inactivated flu and COVID-19 vaccines allowed).
- Known active HIV, hepatitis B or C infections; patients with inactive or cured infections may be eligible.
- Taking corticosteroids above 10 mg/day prednisone or equivalent.
- History of organ transplantation or systemic immunosuppressive therapy.
- Positive COVID-19 test near study start.
- Serious illness or conditions deemed unsuitable by Investigator.
- History of allergy or sensitivity to LAT010 or its components.
- Conditions interfering with consent, participation, or safety evaluation.
- Pregnant or breastfeeding women.
- Unwilling or unable to comply with study protocol.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
D&H Cancer Research Center
Margate, Florida, United States, 33063
Completed
2
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Terminated
3
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China, 250117
Actively Recruiting
4
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310002
Actively Recruiting
Research Team
L
Lightspeed Study Contact
CONTACT
J
John Li, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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