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

NCT06277219 | Recruiting Phase 1 FDA Drug

• 1 other identifier: LAT010-01
• Study Type: interventional
• Target: 150
• Locations: 2 countries
• Sites: 4

Brief 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. The study consists of 2 parts: Phase 1 dose-escalation and Phase 2 cohort expansion.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (4)

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

  TEAEs

  Up to 18 months

• Incidence of changes in clinical laboratory values (Phase 1)

  Clinical Lab Values

  Up to 15 months

• Incidence of dose-limiting toxicities (DLTs) (Phase 1)

  DLT

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

• Objective response rate (ORR) per RECIST 1.1 (Phase 2)

  ORR

  Up to 24 months

Secondary Outcomes (14)

• Maximum plasma concentration (Cmax) of LAT010

  Through treatment cycles, up to approximately 1 year

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

  Through treatment cycles, up to approximately 1 year

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

  Through treatment cycles, up to approximately 1 year

• Time to maximum concentration of LAT010

  Through treatment cycles, up to approximately 1 year

• Trough concentration of LAT010

  Through treatment cycles, up to approximately 1 year

Other Outcomes (2)

• Epigenetic assessment of the proliferation and activation of CD4+ Treg cells, CD8+ T cells, and natural killer (NK) cells.

  Through the end of Cycle 1 (each cycle is 28 days) in Phase 1

• Optional flow cytometry assessment of the proliferation and activation of CD4+ Treg cells, CD8+ T cells, and NK cells.

  Through treatment cycles in Phase 2, up to approximately 1 year

Study Arms (2)

Phase 1 LAT010 Dose Escalation

EXPERIMENTAL

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.

Drug: LAT010

Phase 2 LAT010 Dose Expansion

EXPERIMENTAL

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.

Drug: LAT010; Drug: LAT010 + ICI

Interventions

LAT010 DRUG

LAT010 monotherapy

Phase 1 LAT010 Dose Escalation; Phase 2 LAT010 Dose Expansion

LAT010 + ICI DRUG

LAT010 combination with PD-1 inhibitor

Phase 2 LAT010 Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Latticon Antibody Therapeutics, Inc: lead

Study Sites (4)

D&H Cancer Research Center

Margate, Florida, 33063, United States

COMPLETED

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

TERMINATED

Cancer Hospital of Shandong First Medical University

Jinan, Shandong, 250117, China

RECRUITING

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310002, China

RECRUITING

Study Officials

• John Li, PhD

  Latticon Antibody Therapeutics, Inc

  STUDY CHAIR

Central Study Contacts

Lightspeed Study Contact

CONTACT

202-913-8881; lightspeed-1@latticon.com

John Li, PhD

CONTACT

john.li@latticon.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2024
• First Posted: February 26, 2024
• Study Start: June 5, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2); US (2)