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Advanced Solid TumorPhase 1/2LIGHTSPEED-1NCT06277219

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

A Phase 1/2 study testing LAT010 and LAT010 + ICI in people with Advanced Solid Tumor, run by Latticon Antibody Therapeutics, Inc at 4 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
LAT010 and LAT010 + ICI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
4 sitesin 2 countries
Study dates
5 Jun 2024to Mar 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • For Phase 1 and Phase 2:
  • Patients have voluntarily signed the informed consent.
  • Patients are willing and able to comply with the protocol-related procedures (including screening evaluations), such as visits, treatment plans, laboratory assessments, and other requirements of the study.
  • Male or female aged ≥18 years old.
  • Patients meet the following diagnoses:
  • Patients have histologically or cytologically documented diagnosis of locally advanced or metastatic solid tumors with evidence of progressive disease according to RECIST 1.1, and
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  • 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, or
  • No additional established line of standard therapy is available, or
  • There is a contraindication for the indicated standard therapies in the opinion of the Investigator.
  • (Note: Tumor types of primary interest in Phase 1 include but are not limited to malignant melanoma, renal cell carcinoma, non-small cell lung cancer, gastric carcinoma, hepatocellular carcinoma, pancreatic adenocarcinoma, breast carcinoma, ovarian carcinoma, and colorectal carcinoma.)
  • Patients have at least one measurable tumor lesion, defined as a lesion with the longest measurable diameter of non-lymph node lesions by imaging (CT/MRI) of ≥10 mm or the short diameter of a single pathological lymph node lesion of ≥15 mm.
  • Expected life expectancy of >12 weeks per the Investigator.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 for Phase 1. ECOG score of 0 to 2 for Phase 2.
  • If a patient has had prior major surgery, at least 4 weeks must have elapsed at the time of screening.
  • Patients have adequate pulmonary, cardiovascular, hematological, liver, and renal function, per Investigator assessment.
  • Patients have not received any IL-2 therapy within 12 months before the first dose of LAT010.
  • Laboratory values at screening are as follows:
  • Hematology: i. Absolute neutrophil count (ANC) ≥1,500 cells/mm3 ii. Platelet count ≥75,000 cells/mm3 (no blood components or cell growth factors are used as supportive care within 7 days before the first dose of LAT010) iii. Hemoglobin ≥9.0 g/dL, transfusion of red blood cells allowed to reach threshold target if >7 days b. Renal: i. Creatinine clearance >30 mL/min as derived from the Cockcroft-Gault glomerular filtration rate estimation c. Coagulation: i. International Normalized Ratio (INR) ≤1.5× the upper limit of normal (ULN) ii. Prothrombin time (PT) or activated partial thromboplastin time (APTT) ≤1.5×ULN unless undergoing anticoagulation therapy d. Liver: i. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤3.0×ULN without liver metastasis or ≤5×ULN with liver metastasis ii. Bilirubin <1.5×ULN (unless Gilbert syndrome is confirmed)
  • Any toxicity of previous treatment has recovered to Grade ≤1, unless the toxicity is judged by the Investigator to pose no safety risk, such as alopecia (any grade) or fatigue (up to Grade 2 allowed).
  • Female patients of childbearing potential and sexually active male patients with female partners of childbearing potential must agree to use effective contraceptive measures (including concomitant use of a spermicide with barrier method, intrauterine device, or hormonal contraceptives) from signing the informed consent form to at least 90 days after the last dose of LAT010. Female patients of childbearing age and women <12 months after menopause must have a negative pregnancy test result within 7 days before the first dose of LAT010.
  • Male patients must not donate sperm starting at screening and throughout the study period and for at least 90 days after the final study drug administration.
  • For Phase 2 only:
  • Patients must meet the following criteria:
  • Patients are willing and able to undergo baseline and on-treatment biopsies of the tumor. If a patient has residual tumor masses that can only be accessed with significant risk, available archived biopsies (frozen or formalin-fixed) may serve as baseline specimens with the Sponsor's approval.
  • Patients have been diagnosed and histologically confirmed with a tumor type being selected for the Phase 2 trial.
  • Patients have received the established standard therapies for the selected tumor type prior to enrolling to this study and patients consent that they may be delaying or forgoing specific treatments known to confer a clinical benefit for their disease.
  • Must have received no more than 1 prior line of anti-angiogenic therapy, e.g., anti-vascular endothelial growth factor (anti-VEGF) therapy

Who cannot join

  • Cardiovascular exclusions:
  • Patient has a medical history of an arterial thrombotic event, stroke, or transient ischemia attack within the past 6 months.
  • Patient has a medical history of symptomatic congestive heart failure (New York Heart Association classes III or IV) or an uncontrolled clinically significant cardiac arrhythmia that requires treatment.
  • Patient has a medical history of myocardial infarction or unstable angina within 6 months before the first dose of LAT010.
  • Patient has a QTc prolongation to >480 milliseconds (ms) based on a 12-lead ECGs in triplicate.
  • Other exclusions:
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  • Patient is actively enrolled in another clinical study, unless it is an observational (noninterventional) clinical study or the follow-up component of an interventional study.
  • Use of another systemic anti-cancer therapy within 3 weeks or 5 half- lives after the first dose of LAT010, whichever is shorter.
  • Patient has active central nervous system (CNS) metastases. However, definitely treated CNS metastases (such as surgery, radiotherapy) that are stable for at least 2 weeks prior to the first dose of LAT010 are acceptable.
  • Patient has another active primary malignancy that has not been treated with curative intent. Exceptions could be made upon discussion with the Medical Monitor. However, non-metastatic cutaneous basal cell or squamous cell carcinoma, or non-muscle invasive bladder cancer are acceptable.
  • Patient has history of severe irAEs from a previous treatment, which are defined as a Grade 4 event requiring corticosteroid treatment or a Grade 3 event requiring corticosteroid treatment of >10 mg/day prednisone or equivalent dose for >12 weeks.
  • Recent medical concerns exclusions:
  • Patient has evidence of active infection requiring IV antibiotics within 7 days prior to the first dose of LAT010.
  • Patient has active uncontrolled bleeding within 7 days prior to the first dose of LAT010.
  • Patient has serious or non-healing wound, fistula, skin ulcer, or non-healing bone fracture within 7 days prior to the first dose of LAT010.
  • Patient has had a live virus vaccine within 30 days prior to the first dose of LAT010 (Note: Inactivated seasonal flu vaccine is acceptable. COVID-19 vaccination is also allowed.)
  • Patient has known replicating human immunodeficiency virus infection, active hepatitis B infection, or hepatitis C infection. However, hepatitis B virus (HBV) carriers without active disease (HBV DNA titer < 1000 cps/mL or 200 IU/mL) or patients with cured hepatitis C (negative HCV RNA test) may be enrolled. Patients with treated non-replicative disease are acceptable.
  • Patient is taking corticosteroids >10 mg/day of prednisone or equivalent.
  • Patient has had an organ transplantation or is on systemic immunosuppressive therapy.
  • Patient has a positive test result for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) viral RNA test, either asymptomatic or present with symptoms of Coronavirus disease 2019 (COVID-19) on Day -2 or Day -1.
  • Patient has a serious illness considered by the Investigator to be unsuitable for participating in this study.
  • Any condition that, in the opinion of the Investigator, may interfere with the evaluation of the study drug or interpretation of the patient's safety or study results.
  • Patient has a history of sensitivity to LAT010, or components thereof, or a history of drug or other allergy that in the opinion of the Investigator or Medical Monitor (if appropriate), contraindicates their participation.
  • Patient has any illness, medical condition, organ system dysfunction, or social situation, including mental illness or substance abuse, that is deemed by the Investigator to be likely to interfere with a patient's ability to sign the informed consent form (ICF), adversely affect the patient's ability to cooperate and participate in the study, or compromise the interpretation of study results.
  • Patient is breastfeeding or pregnant as confirmed by pregnancy tests performed within 7 days before the first dose of LAT010.
  • Patient is unwilling or unable to follow protocol requirements.

Trial locations and contacts

4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Lightspeed Study Contact contact

202-913-8881

lightspeed-1@latticon.com

John Li, PhD contact

john.li@latticon.com

4 sites in 2 countries

United States2 sites

  • D&H Cancer Research Center

    Margate, Florida, 33063

    Completed

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

    Terminated

Other trials in United States

China2 sites, 2 recruiting

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310002

    Jian Ruan, MD

    Recruiting

  • Cancer Hospital of Shandong First Medical University

    Jinan, Shandong, 250117

    Yan Zhang, MD

    Recruiting

Other trials in China

About this study

Official title: A Phase 1/2, Dose-Escalation and Cohort-Expansion Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Efficacy of LAT010 in Patients With Advanced Solid Tumors (LIGHTSPEED-1)

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.

Read the detailed description

Interleukin-2 (IL-2) agonists have shown significant antitumor activities but are associated with severe toxic side effects, due to prioritized activation of high-affinity IL-2 receptor (i.e., IL2Rαβγ). LAT010 is a human IL-2 based immunocytokine designed to exclusively interact with intermediate-affinity IL-2 receptor (i.e., IL2Rβγ) but not the high-affinity IL2Rαβγ receptor. Its exceptional selectivity in activating CD8+ T cells and NK cells may confer the clinical benefits of IL-2 in promoting antitumor immunity without the associated safety concerns.

Phase 1 of the study will examine LAT010 in an accelerated and standard "3+3" dose-escalation design. It consists of 7 planned cohorts. Approximately 20 to 50 patients with locally advanced or metastatic solid tumors will be enrolled in the cohorts. Each treatment cycle consists of 4 weeks, during which patients will receive an IV injection of LAT010 at the assigned dose once weekly. The DLT observation period is the first treatment cycle (28 days).

Phase 2 will be initiated after the MTD or a RP2D has been determined in Phase 1. Approximately up to 30 patients per cohort by tumor type will be enrolled to further evaluate the safety and efficacy of LAT010 in the treatment of selected tumor types at multiple dose levels based on the results of Phase 1. The primary objective of Phase 2 study is to define the preliminary efficacy in the setting of advanced cancers with high unmet medical needs.

Being tested
LAT010, LAT010 + ICI

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LAT010Drug

    LAT010 monotherapy

  • LAT010 + ICIDrug

    LAT010 combination with PD-1 inhibitor

Study groups in NCT06277219
Study groupRoleWhat they receive
Phase 1 LAT010 Dose EscalationExperimentalLAT010 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.
Receives: Drug: LAT010
Phase 2 LAT010 Dose ExpansionExperimentalLAT010 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.
Receives: Drug: LAT010; Drug: LAT010 + ICI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) (Phase 1)

    TEAEs

    Measured: Up to 18 months

  2. Incidence of changes in clinical laboratory values (Phase 1)

    Clinical Lab Values

    Measured: Up to 15 months

  3. Incidence of dose-limiting toxicities (DLTs) (Phase 1)

    DLT

    Measured: The first treatment cycle (28 days) from Cycle 1 Day 1

  4. Objective response rate (ORR) per RECIST 1.1 (Phase 2)

    ORR

    Measured: Up to 24 months

Secondary outcomes (14)

  1. Maximum plasma concentration (Cmax) of LAT010

    Cmax

    Measured: Through treatment cycles, up to approximately 1 year

  2. Area under the plasma concentration-time curve (AUC) of LAT010

    AUC

    Measured: Through treatment cycles, up to approximately 1 year

  3. Terminal phase half-life (t1/2) of LAT010

    t½

    Measured: Through treatment cycles, up to approximately 1 year

  4. Time to maximum concentration of LAT010

    Tmax

    Measured: Through treatment cycles, up to approximately 1 year

  5. Trough concentration of LAT010

    Ctrough

    Measured: Through treatment cycles, up to approximately 1 year

  6. Volume of distribution of LAT010

    Vd

    Measured: Through treatment cycles, up to approximately 1 year

  7. Clearance of LAT010

    CL

    Measured: Through treatment cycles, up to approximately 1 year

  8. ADA occurrence and titer in serum

    ADA

    Measured: Through safety follow-up period, up to approximately 15 months

  9. Objective response rate (ORR) per RECIST 1.1 (Phase 1 )

    ORR

    Measured: Up to 24 months

  10. Duration of response (DOR)

    DOR

    Measured: Up to 24 months

  11. Disease control rate (DCR)

    DCR

    Measured: Up to 24 months

  12. Progression-free survival (PFS)

    PFS

    Measured: Up to 24 months

  13. Overall survival (OS)

    OS

    Measured: Up to 24 months

  14. Incidence of AEs and SAEs

    AEs/SAEs

    Measured: From informed consent signed through safety follow-up period, up to approximately 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2024
  2. Study start5 Jun 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06277219
Sponsor's protocol ID
LAT010-01
Acronym
LIGHTSPEED-1
Status last verified
Jul 2025
First submitted
3 Feb 2024
Last updated
8 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing LAT010 and LAT010 + ICI in people with Advanced Solid Tumor, run by Latticon Antibody Therapeutics, Inc at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lightspeed Study Contact (202-913-8881, lightspeed-1@latticon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) (Phase 1) (time frame: Up to 18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06277219.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.

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