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

NCT06770764 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: TRT-ODC-IL2-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Solid Tumors; Metastatic Solid Tumors

Keywords

ODC-IL2; Tumors

Outcome Measures

Primary Outcomes (3)

• Incidence of Dose Limiting Toxicities (DLTs)

  28 days

• Incidence of Treatment-Emergent Adverse Events (TEAEs)

  All AEs will be assessed per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading for cytokine release syndrome (CRS) based on investigator assessment.

  From the first administration of study drug, throughout the course of the study, and for 90 days after the last dose of study drug

• Incidence of changes in clinical laboratory abnormalities

  From the first administration of study drug, throughout the course of the study, and for 90 days after the last dose of study drug

Secondary Outcomes (6)

• Serum concentrations of ODC-IL2, free IL-2 and drug backbone following release of IL-2

  24 months

• Investigator-assessed Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

  24 months

• Disease control rate (DCR) by RECIST 1.1

  through 6 months after start of treatment

• Duration of response (DoR) by RECIST 1.1

  24 months

• Progression-free survival (PFS) by RECIST 1.1

  24 months

Study Arms (2)

ODC-IL2 monotherapy dose escalation

EXPERIMENTAL

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.

Drug: ODC-IL2

ODC-IL2 monotherapy dose expansion

EXPERIMENTAL

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.

Drug: ODC-IL2

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.

Also known as: Investigation product

ODC-IL2 monotherapy dose escalation; ODC-IL2 monotherapy dose expansion

Eligibility Criteria

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

You may qualify if:

• Each patient must meet all the following criteria to participate in the study:
• Histologically or cytologically confirmed advanced or metastatic solid tumors, for which no other standard treatment is available or appropriate, or for which the Trutino Biosciences Protocol #: TRT-ODC-IL2-001 Version: 1.0 Date: 20 September 2024 standard of care is refused by the patient due to tolerability or the Investigator believes the patient will not tolerate standard-of-care therapy
• Advanced or metastatic tumors measurable per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Life expectancy of at least 3 months;
• Age ≥ 18 years;
• Signed, written Institutional Review Board (IRB)/Ethics Committee (EC)-approved informed consent
• Acceptable liver function:
• Bilirubin ≤ 1.5 times upper limit of normal (ULN) or ≤ 5 × institutional ULN for patients who have serum bilirubin increases due to underlying Gilbert's Syndrome (familial benign unconjugated hyperbilirubinemia).
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase ≤ 2.5 x ULN (if liver metastases are present, then ≤ 5 x ULN is allowed)
• Acceptable renal function:
• Calculated creatinine clearance ≥ 50 mL/min using the Cockcroft-Gault equation.
• Acceptable hematologic status:
• Absolute neutrophil count ≥ 1500 cells/mm3
• Platelet count ≥ 75,000 (plt/mm3)

You may not qualify if:

• New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on electrocardiogram (ECG)
• Have a corrected QT interval (using Fridericia's correction formula) (QTcF) of \> 470 msec
• Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
• Known active brain metastases; patients with previously treated, clinically stable, radiologically stable brain metastases (without evidence of progression in 4 weeks) and without the requirement for treatment with corticosteroids in prior 3 weeks may be considered for enrollment after discussion with the Medical Monitor
• History of prior organ transplant
• Conditions requiring systemic treatment with corticosteroids or any other form of immunosuppressive therapy within 7 days prior to start of study drug.
• History of autoimmune diseases requiring systemic immunosuppressive therapy in the last 2 years
• Pregnant or nursing women.
• Treatment with radiation therapy, major surgery, chemotherapy, or investigational therapy within 4 weeks prior to study entry (6 weeks for nitrosoureas or mitomycin C). Radiation for palliation of pain is allowed within 1 week prior to study entry, but the lesion should not be selected as a target lesion for RECIST analysis.
• Unwillingness or inability to comply with procedures required in this protocol
• Known active infection with human immunodeficiency virus (HIV), human T-cell leukemia virus, type 1 (HTLV-1), hepatitis B virus (HBV), or hepatitis C virus (HCV)
• Patients with a history of hepatitis B or C are allowed if HBV DNA or HCV RNA are undetectable
• Active infection with HIV and CD4+ T-cell count \<350/μL. Patients not on established anti-retroviral therapy for at least 4 weeks and having a detectable HIV viral load
• Serious uncontrolled nonmalignant disease (e.g., renal failure, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
• Prior treatment with an IL-2 targeted treatment, unless given as a part of a tumor infiltrating lymphocyte treatment combination;

Sponsors & Collaborators

• Trutino Biosciences Inc.: lead

Study Sites (1)

HonorHealth

Scottsdale, Arizona, 85258, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Krystal Martinez

CONTACT

602.358.8300; kmartinez@td2inc.com

Krishna Patel

CONTACT

602.358.8300; kpatel@td2inc.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: January 2, 2025
• First Posted: January 13, 2025
• Study Start: December 30, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)