First-in-Human Study of INT-1B3 in Patients With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT04675996|
Recruitment Status : Recruiting
First Posted : December 19, 2020
Last Update Posted : February 7, 2022
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor||Drug: INT-1B3||Phase 1|
The investigational medicinal product INT-1B3 is a lipid nanoparticle formulated microRNA (miR-193a-3p) mimic destined for therapeutic intervention in oncology. Preclinical work showed that INT-1B3 has a multi-target mechanism of action with an anti-proliferative, anti-metastatic, anti-migration, cell cycle disruption, induction of apoptosis effect and modulation on the tumor microenvironment leading to significant induction of T cell-mediated immune response.
The first part of the study (Phase I) is a dose-escalation phase to determine the maximal tolerated dose and the recommended Phase 2 dose, as well as the safety profile of INT-1B3 in patients with advanced malignancies.The subsequent expansion phase of the study (Phase Ib) will further explore safety, pharmacokinetics, pharmacodynamic responses, and antitumor activity of INT-1B3 in patients with selected cancer types treated at the recommended phase 2 dose.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/Ib, Open-label, Multiple Ascending Dose, First-in-Human Study, to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of INT-1B3 in Patients With Advanced Solid Tumors|
|Actual Study Start Date :||December 18, 2020|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2024|
Experimental: Phase 1/1b
Phase 1: dose escalation phase with a 'hybrid' 3+3 design in all-comers cancer patients. Approximately 30 patients will be included.
Phase 1b: dose expansion phase in selected tumor types at the recommended phase 2 dose. Approximately 50 patients will be included.
60-min i.v. infusions twice per week in 21-day cycles
- Incidence and severity of treatment-related adverse events and serious adverse events [ Time Frame: Up to 24 months ]Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE criteria v 5.0, incidence of dose limiting toxicities (DLTs), adverse events leading to discontinuation and deaths
- Recommended Phase 2 Dose of INT-1B3 [ Time Frame: Up to 24 months ]Based on dose-limiting toxicities, the maximal tolerated dose and all other available safety, pharmacokinetic/pharmacodynamic data as assessed by the cohort review committee
- Area under the curve [ Time Frame: Up to 24 months ]Area under the plasma concentration time curve of INT-1B3
- Maximum plasma concentration [ Time Frame: Up to 24 months ]Highest observed plasma concentration of INT-1B3
- Time of maximum plasma concentration [ Time Frame: Up to 24 months ]Time to reach highest observed plasma concentration of INT-1B3
- Half-life [ Time Frame: Up to 24 months ]Plasma concentration half-life of INT-1B3
- Objective response rate of INT-1B3 [ Time Frame: Up to 24 months ]Objective response rate according to standard criteria by RECIST1.1
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04675996
|Contact: Karlijn Kroon, MD||+31 30 760 76 firstname.lastname@example.org|
|Institut Jules Bordet||Recruiting|
|Brussels, Wallonie, Belgium, 1000|
|Contact: Kotecki, MD|
|GZA (Gasthuiszusters Antwerpen)||Recruiting|
|Contact: Strijbos, MD|
|The Netherlands Cancer Institute||Recruiting|
|Contact: Opdam, MD|
|Contact: Robbrecht, MD|
|Study Director:||Roel Schaapveld, PhD||InteRNA|