Study of Escalating Doses of INA03 Administered Intravenously as Single Agent in Adult Patients W… (NCT03957915) | Clinical Trial Compass
CompletedEarly Phase 1
Study of Escalating Doses of INA03 Administered Intravenously as Single Agent in Adult Patients With Relapse/Refractory Acute Leukemia
France33 participantsStarted 2020-05-29
Plain-language summary
This Phase 1 Study is an open-label, non-randomized, dose escalation, safety, efficacy, pharmacokinetic, and pharmacodynamic evaluation study of INA03 administered as a single agent IV infusion every 2 weeks to patients ≥18 years of age with R/R AML, MLL, or ALL.
The study will be performed in 2 parts: a Dose Titration for Day 1 study (Part 1) followed by a Dose Escalation Part (Part 2) of INA03 used as monotherapy.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. AST and or ALT ≤ 2.5 ULN
✓. Total bilirubin level \< 1.5 ULN (except Gilbert disease)
✓. Serum creatinine ≤ 1.5 ULN
✓. LDH \< 3-5 ULN
✓. Uric acid ≤8 mg/dl
✓. Electrolyte panel within normal range
✓. Urine Dipstick Reading negative for proteinuria or, if documentation of +1 results for protein on dipstick reading, then total urinary protein ≤ 500 mg and measured creatinine clearance ≥50mL/min/1.73m2 from a 24-hour urine collection
✓. Patients who have recovered at least CTCAE grade \<2 5. Life expectancy greater than 3 months 6. Women of child bearing potential must be willing to use birth control method during the study duration (W4 or early termination) plus 30 days. Male partner of women must use condom; in case of male patient, he must agree to use condom during the study duration (W4 or early termination) plus 30 days; 7. Pregnancy test (females of childbearing potential): negative 8. Signed informed consent indicating that they have been informed of the procedures to be followed, an is willing and able to comply the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts 9. Patient affiliated to the national "Social Security" regimen or beneficiary of this regi-men
Exclusion criteria
✕. Patients with acute promyelocytic leukemia
✕. Patients with more than 30% marrow erythroid cells
What they're measuring
1
Determination of the minimal erythroblastopenia-inducing dose (MEID) for INA03 in adults with refractory/relapsed acute leukemia
Timeframe: within 2 weeks from initial dosing
2
Determination of the maximum tolerated dose (MTD) for subsequent administrations (D15 from initial dosing and beyond) for INA03 in adults with refractory/relapsed acute leukemia
Timeframe: 28 days from the first administration of INA03
. Patients who have been treated with any anti-TfR antibody
✕. Allogeneic stem cell transplantation in the last 6 months or with persistent active GVHD. Autologous bone marrow transplant in the last 3 months
✕. Last dose of prior chemotherapy, immunotherapy or investigational agent within 14 days or within 5 half-lives before baseline receipt of study medication, except for hydroxyurea and corticosteroids
✕. ≤12 weeks for cranial radiation therapy
✕. ≤ 4 weeks for wide field radiation therapy
✕. ≤2 weeks for involved field radiation therapy 15. Major surgery ≤ 4weeks prior to starting study drug or who have not recovered from side effects of such therapy 16. Known diagnosis of HIV infection (HIV testing is not mandatory). 17. History of another primary malignancy that is currently clinically significant or currently requires active intervention 18. Pregnant or breastfeeding patient; 19. Active drug or alcohol dependence; 20. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.