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

ConditionsAdvanced Solid TumorsMetastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorTrutino Biosciences Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • ODC-IL2

    Drug

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: ODC-IL2 monotherapy dose escalationExperimental treatment 1 intervention
Group B: ODC-IL2 monotherapy dose expansionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Dose Limiting Toxicities (DLTs)

Time frame
28 days
2

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.

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
3

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

Secondary outcomes

1

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

Time frame
24 months
2

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

Time frame
24 months
3

Disease control rate (DCR) by RECIST 1.1

Time frame
through 6 months after start of treatment
4

Duration of response (DoR) by RECIST 1.1

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Trutino Biosciences Inc.

Lead sponsor

Source ClinicalTrials.gov
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