Advanced Solid TumorsPhase 1NCT06770764
Dose Escalation and Expansion Study Evaluating ODC-IL2 in Adult Patients With Advanced or Metastatic Solid Tumors
A Phase 1 study testing ODC-IL2 in people with Advanced Solid Tumors and Metastatic Solid Tumors, run by Trutino Biosciences Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, Metastatic Solid Tumors
- What is being tested?
- ODC-IL2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Dec 2024to Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 18Show fewer
- 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)
- Hemoglobin ≥ 9 g/dL
- A negative serum pregnancy test (if a woman of childbearing potential);
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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;
- Known sensitivity to IL-2 or any of the excipients in ODC-IL2;
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
HonorHealth
Scottsdale, Arizona, 85258
Justin Moser, MD, 480-323-1350, jmoser@honorhealth.com
Justin Moser, MD
About 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
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.
Read the 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
- Being tested
- ODC-IL2
- Keywords
- ODC-IL2, Tumors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ODC-IL2Drug
Also called Investigation product
ODC-IL2 as a single agent infused IV over 60 minutes on Days 1 and 15 of a 28 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: ODC-IL2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose Limiting Toxicities (DLTs)
Measured: 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.
Measured: 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
Measured: 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
Measured: 24 months
Investigator-assessed Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Measured: 24 months
Disease control rate (DCR) by RECIST 1.1
Measured: through 6 months after start of treatment
Duration of response (DoR) by RECIST 1.1
Measured: 24 months
Progression-free survival (PFS) by RECIST 1.1
Measured: 24 months
To assess tumor biopsies for pharmacodynamic markers of target engagement and immune pathway activation
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start30 Dec 2024
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trutino Biosciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770764
- Sponsor's protocol ID
- TRT-ODC-IL2-001
- Status last verified
- Jan 2025
- First submitted
- 2 Jan 2025
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant study data and trial results will be shared with the study Investigators and the FDA, as well as presented and/or published in medical journals and conferences.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06770764
- Acronym / sponsor ID
- TRT-ODC-IL2-001
- Conditions
- Advanced Solid Tumors, Metastatic Solid Tumors
- Keywords
- ODC-IL2, Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Trutino Biosciences Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ODC-IL2 monotherapy dose escalation | Experimental | Drug: ODC-IL2All patients will receive ODC-IL2 as a single agent infused IV over 60 minutes on Days 1 and 15 of a 28 day cycle. |
| ODC-IL2 monotherapy dose expansion | Experimental | Drug: ODC-IL2All patients will receive ODC-IL2 as a single agent infused IV over 60 minutes on Days 1 and 15 of a 28 day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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;
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ODC-IL2Also: Investigation productODC-IL2 as a single agent infused IV over 60 minutes on Days 1 and 15 of a 28 day cycle. | Drug | ODC-IL2 monotherapy dose escalation, ODC-IL2 monotherapy dose expansion |
Primary outcome
Incidence of Dose Limiting Toxicities (DLTs)
Time frame: 28 days
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: From the first administration of study drug, throughout the course of the study, and for 90 days after the last dose of study drug
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.
Incidence of changes in clinical laboratory abnormalities
Time frame: From the first administration of study drug, throughout the course of the study, and for 90 days after the last dose of study drug
6 secondary outcomes
Serum concentrations of ODC-IL2, free IL-2 and drug backbone following release of IL-2
Time frame: 24 months
Investigator-assessed Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time frame: 24 months
Disease control rate (DCR) by RECIST 1.1
Time frame: through 6 months after start of treatment
Duration of response (DoR) by RECIST 1.1
Time frame: 24 months
Progression-free survival (PFS) by RECIST 1.1
Time frame: 24 months
To assess tumor biopsies for pharmacodynamic markers of target engagement and immune pathway activation
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Individual participant dataSharing planned: Yes. The individual participant study data and trial results will be shared with the study Investigators and the FDA, as well as presented and/or published in medical journals and conferences.
Related trials for Advanced Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ODC-IL2 in people with Advanced Solid Tumors and Metastatic Solid Tumors, run by Trutino Biosciences Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Krystal Martinez (602.358.8300 ext. 4285, kmartinez@td2inc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose Limiting Toxicities (DLTs) (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.