NCT06770764

Dose Escalation and Expansion Study Evaluating ODC-IL2 in Adult Patients With Advanced or Metastatic Solid Tumors

A Phase 1/1b, Multicenter, Open-label, Dose Escalation and Expansion Study Evaluating the Safety, Pharmacodynamics, and Pharmacokinetics of ODC-IL2 Administered Via Intravenous Infusion in Adult Patients With Advanced or Metastatic Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Trutino Biosciences Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a first-in-human, Phase I, multicenter, open-label, dose escalation study with dose expansion to evaluate the safety and antitumor activity of ODC-IL2 in patients with advanced or metastatic solid tumors. ODC-IL2 is a conditionally activated IL-2 prodrug and will be administered as a single agent via intravenous infusion on Days 1 and 15 of a 28-day cycle. Up to approximately 50 patients will be enrolled in this study.

Detailed description

This is a first-in-human, Phase I, multicenter, open-label, dose-escalation and expansion study evaluating the safety, pharmacodynamics, pharmacokinetics and preliminary antitumor activity of ODC-IL2 for the treatment of patients with advanced or metastatic solid tumors. Part 1 of the study is dose escalation of ODC-IL2 and up to 18 to 30 patients (for up to 10 dose levels) or more will be enrolled in this portion of the study (depending on the number of dose escalation cohorts and patients per cohort required). Once the MTD or RDR has been established in dose escalation, a Part 2 expansion will begin. The dose-expansion cohort at a single dose level will enroll approximately 20 patients with advanced solid tumors to further evaluate safety and assess for signals of antitumor activity. The objective of the dose-escalation and expansion is to define, with a limited number of patients, the safety and toxicity characteristics of ODC-IL2. The study drug ODC-IL2 is a conditionally activated IL-2 prodrug and will be administered as a single agent by IV infusion over a 60-minute period on Days 1 and 15 of the treatment cycle. A treatment cycle is defined as 28 days. This trial will enroll adult patients with advanced or metastatic solid tumors that have not responded to or have recurred following treatment with available therapies. Up to approximately 50 evaluable patients may be enrolled in this study across the dose-escalation and dose-expansion cohorts. Enrollment in this study is anticipated to be 15 to 18 months.

Conditions

• Advanced Solid Tumors
• Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	ODC-IL2	ODC-IL2 as a single agent infused IV over 60 minutes on Days 1 and 15 of a 28 day cycle.

Timeline

• Start date: 2024-12-30
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2025-01-13
• Last updated: 2025-01-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study