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)
Latticon Antibody Therapeutics, Inc
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.
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 LAT0…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: For Phase 1 and Phase 2: 1. Patients have voluntarily signed the informed consent. 2. 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. 3. Male or female aged ≥18 years old. 4. 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 in…
Interventions
- DrugLAT010
LAT010 monotherapy
- DrugLAT010 + ICI
LAT010 combination with PD-1 inhibitor
Locations (4)
- D&H Cancer Research CenterMargate, Florida
- Huntsman Cancer InstituteSalt Lake City, Utah
- Cancer Hospital of Shandong First Medical UniversityJinan, Shandong
- The First Affiliated Hospital of Zhejiang University School of MedicineHangzhou, Zhejiang