RECRUITING

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

Conditions

Advanced Solid Tumors Metastatic Solid Tumors ODC-IL2 Tumors

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-12-30

Study Completion:2027-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06770764

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 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 2. Advanced or metastatic tumors measurable per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria; 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 4. Life expectancy of at least 3 months; 5. Age ≥ 18 years; 6. Signed, written Institutional Review Board (IRB)/Ethics Committee (EC)-approved informed consent 7. 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) 8. Acceptable renal function: 9. Acceptable hematologic status: * Absolute neutrophil count ≥ 1500 cells/mm3 * Platelet count ≥ 75,000 (plt/mm3) * Hemoglobin ≥ 9 g/dL 10. A negative serum pregnancy test (if a woman of childbearing potential); 11. Women of childbearing potential (WOCBP) and men with WOCBP partners must agree to use adequate contraception (hormonal method of birth control; intrauterine devices or abstinence) prior to study entry, for the duration of study participation and for 4 months after the last dose of study drug. Should a female trial participant or a female partner of a male trial participant become pregnant or suspect she is pregnant during the study, the Investigator must be informed immediately.	1. 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) 2. Have a corrected QT interval (using Fridericia's correction formula) (QTcF) of \> 470 msec 3. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy 4. 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 5. History of prior organ transplant 6. Conditions requiring systemic treatment with corticosteroids or any other form of immunosuppressive therapy within 7 days prior to start of study drug. 7. History of autoimmune diseases requiring systemic immunosuppressive therapy in the last 2 years 8. Pregnant or nursing women. 9. 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. 10. Unwillingness or inability to comply with procedures required in this protocol 11. 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 12. 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 13. Prior treatment with an IL-2 targeted treatment, unless given as a part of a tumor infiltrating lymphocyte treatment combination; 14. Known sensitivity to IL-2 or any of the excipients in ODC-IL2; 15. Active treatment with heparin or heparin-related therapies, unless the patient can be transitioned to a non-heparin treatment for the clinical condition with an adequate washout prior to enrollment in the study.

Inclusion Criteria

Exclusion Criteria

1. 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
2. Advanced or metastatic tumors measurable per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria;
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
4. Life expectancy of at least 3 months;
5. Age ≥ 18 years;
6. Signed, written Institutional Review Board (IRB)/Ethics Committee (EC)-approved informed consent
7. 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)
8. Acceptable renal function:
9. Acceptable hematologic status:
* Absolute neutrophil count ≥ 1500 cells/mm3
* Platelet count ≥ 75,000 (plt/mm3)
* Hemoglobin ≥ 9 g/dL
10. A negative serum pregnancy test (if a woman of childbearing potential);
11. Women of childbearing potential (WOCBP) and men with WOCBP partners must agree to use adequate contraception (hormonal method of birth control; intrauterine devices or abstinence) prior to study entry, for the duration of study participation and for 4 months after the last dose of study drug. Should a female trial participant or a female partner of a male trial participant become pregnant or suspect she is pregnant during the study, the Investigator must be informed immediately.

1. 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)
2. Have a corrected QT interval (using Fridericia's correction formula) (QTcF) of \> 470 msec
3. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
4. 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
5. History of prior organ transplant
6. Conditions requiring systemic treatment with corticosteroids or any other form of immunosuppressive therapy within 7 days prior to start of study drug.
7. History of autoimmune diseases requiring systemic immunosuppressive therapy in the last 2 years
8. Pregnant or nursing women.
9. 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.
10. Unwillingness or inability to comply with procedures required in this protocol
11. 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
12. 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
13. Prior treatment with an IL-2 targeted treatment, unless given as a part of a tumor infiltrating lymphocyte treatment combination;
14. Known sensitivity to IL-2 or any of the excipients in ODC-IL2;
15. Active treatment with heparin or heparin-related therapies, unless the patient can be transitioned to a non-heparin treatment for the clinical condition with an adequate washout prior to enrollment in the study.

Contacts and Locations

Study Contact

Krystal Martinez

CONTACT

602.358.8300

kmartinez@td2inc.com

Krishna Patel

CONTACT

602.358.8300

kpatel@td2inc.com

Study Locations (Sites)

HonorHealth

Scottsdale, Arizona, 85258

United States

Collaborators and Investigators

Sponsor: Trutino Biosciences Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-30

Study Completion Date2027-03

Study Record Updates

Study Start Date2024-12-30

Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

ODC-IL2
Tumors

Additional Relevant MeSH Terms

Advanced Solid Tumors
Metastatic Solid Tumors