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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Trutino Biosciences Inc.
Study ID
NCT06770764
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Solid Tumors
  • Metastatic Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 30, 2024
Status verified
Jan 2025
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: ODC-IL2 monotherapy dose escalation
    All patients will receive ODC-IL2 as a single agent infused IV over 60 minutes on Days 1 and 15 of a 28 day cycle.
  • Experimental: ODC-IL2 monotherapy dose expansion
    All patients will receive ODC-IL2 as a single agent infused IV over 60 minutes on Days 1 and 15 of a 28 day cycle.

Primary Outcome Measure

Incidence of Dose Limiting Toxicities (DLTs) [ Time Frame: 28 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
HonorHealthScottsdaleArizona85258
Justin Moser, MD
[email protected]
480-323-1350
Justin Moser, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Scottsdale, AZ

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HonorHealth· Scottsdale, AZ

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