Status:
TERMINATED
First-in-Human Study of INT-1B3 in Patients With Advanced Solid Tumors
Lead Sponsor:
InteRNA
Conditions:
Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a 2 part, multi-center, open-label, First-in-Human clinical study to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of INT-1B3 in the treatment of patients w...
Detailed Description
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 ha...
Eligibility Criteria
Inclusion
- Patient provided a signed written informed consent before any screening procedure
- Patient is male or female, ≥18 years of age (adult patients)
- Patient with histologically or cytologically confirmed advanced and/or metastatic solid tumor, with progressive disease at baseline, for whom no standard treatment is available or who have declined standard therapy
- Patient with evaluable disease per RECIST v1.1, iRECIST
- Patient with a predicted life expectancy of \> 12 weeks
- Patient with Eastern Cooperative Oncology Group performance status of grade 0 - 1
- Patient with hemoglobin ≥ 9.0 g/dL, platelet count ≥ 75×109/L, and absolute neutrophil count ≥ 1.0×109/L
- Patient with adequate renal function
- Patient with adequate liver function
- Patient with adequate coagulation tests
- Female patient of childbearing potential and males should use effective contraception
- Patient is able and willing to comply with the protocol and the restrictions and assessments therein
Exclusion
- Patients on any other anti-cancer therapy, unless at least 4 weeks (or 5 half-lives, whichever is shorter), have elapsed since the last dose before the first administration of INT-1B3. At least 2 weeks should have elapsed since receiving non-palliative radiotherapy.
- Patient with known central nervous system (CNS) metastases, unless previously treated and well-controlled for at least 1 month (defined as clinically stable, no edema, no steroids and stable in 2 scans at least 4 weeks apart)
- Patient with concomitant second malignancies unless curatively treated at least 2 years before study entry with no additional therapy required or anticipated to be required during the study period
- Patient with major surgery within 5 weeks before initiating treatment or with minor surgical procedure within 7 days before initiating treatment
- Patient with active autoimmune disease or persistent immune-mediated toxicity caused by immune checkpoint inhibitor therapy of Grade ≥ 2, except for residual endocrinopathy adequately substituted, vitiligo, Type 1 diabetes mellitus or psoriasis not requiring systemic therapy (\>10mg prednisone equivalent)
- Patient with toxicity (except for alopecia) related to prior anti-cancer therapy and/or surgery, unless the toxicity is either resolved, returned to baseline or grade 1
- Patient with any active neuropathy \> Grade 2 (National Cancer Institute Common Terminology Criteria for Adverse Events v5.0)
- Patient with any condition requiring concurrent use of systemic immunosuppressants or corticosteroids at a daily dose \> 10 mg prednisone equivalent or other immunosuppressive medications within 14 days of study medication administration
- Patient with evidence of active infection that requires systemic antibacterial, antiviral, or antifungal therapy ≤ 7 days before the first dose of study medication
- Patient with uncontrolled or significant cardiovascular disease
- Patient with known active or chronic hepatitis B or C (unless treated with no detectable virus)
- Patient with known history of exposure to human immunodeficiency virus (HIV)
- Patient with any known or underlying medical, psychiatric condition, and/or social situations that, in the opinion of the investigator, would limit compliance with study requirements
- Patient with history of allergy to the study medication or any of its excipients
- Patient that received packed red blood cells or platelet transfusion within 2 weeks of the first dose of study medication
- Female patient: pregnant or breastfeeding
Key Trial Info
Start Date :
December 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2023
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04675996
Start Date
December 18 2020
End Date
March 24 2023
Last Update
February 8 2024
Active Locations (4)
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1
Institut Jules Bordet
Brussels, Wallonia, Belgium, 1000
2
GZA (Gasthuiszusters Antwerpen)
Antwerp, Belgium
3
The Netherlands Cancer Institute
Amsterdam, Netherlands
4
Erasmus MC
Rotterdam, Netherlands