A Phase 1 interventional study of AsiDNA in Advanced Cancer, sponsored by Valerio Therapeutics. Completed at 5 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-24.
Sponsored by Valerio Therapeutics · Phase 1, Interventional, and Treatment
The aim of the study is to assess:
Valerio Therapeutics is the lead sponsor of 25 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Part B only:
Key Exclusion Criteria:
Patient presenting the following abnormal laboratory values at screening:
Part A: AsiDNA as a single agent: The study will follow a dose escalation "3 + 3" cohort design (with 6 dose levels). All patients will receive a loading dose of AsiDNA for 3 consecutive days as iv infusion at Day 1 (D1), Day 2 (D2) and Day 3 (D3), followed by iv infusion once a week (at D8 and D15 of a 21 days treatment period (1 cycle = 21 days). Each subsequent cycle will be administered on a weekly basis (D1, D8, D15) of a 21 days treatment period. Part B: AsiDNA combination with Carboplatin with or without Paclitaxel (Background treatments): * Part B1: Combination cohort of AsiDNA at DL3 (600mg) with Carboplatin AUC 5. * Part B2: Combination cohort of AsiDNA at DL3 (600mg) with Carboplatin AUC 5 and weekly Paclitaxel: 80 mg/m2 (full dose).
Drug: AsiDNA
All patients will receive a loading dose of AsiDNA iv infusion (D1, D2, D3) followed by weekly iv administrations. At cycle 1: Part B1: Carboplatin will be administered by a 1 hour IV infusion at D8, 1 hour after the end of AsiDNA infusion. Part B2: Carboplatin will be administered by a 1 hour IV infusion at D8, 1 hour after the end of AsiDNA infusion and Paclitaxel will be administered by a 1 hour IV infusion at D8, D15, D22 or 1 hour after the end of AsiDNA infusion for weekly administrations. At each other cycle: AsiDNA will be administered on a weekly basis. Part B1: Carboplatin will be administered by a 1 hour IV infusion at D1, 1 hour after the end of AsiDNA infusion. Part B2; Carboplatin will be administered by a 1 hour IV infusion at D1, 1 hour after the end of AsiDNA infusion and Paclitaxel will be administered on a weekly basis by a 1 hour IV infusion. Patients will continue study treatment until disease progression, unacceptable toxicity or patient's refusal to continue.
Determine dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD) of iv infusions of AsiDNA.
DLTs will be based on the toxicities observed during the first 3 weeks of study treatment (i.e, cycle 1: from Day 1 to Day 21) for Part A and during the 4 weeks of study treatment (i.e, cycle 1: from Day 1 to Day 28) for Part B. MTD is defined as the dose immediately below the unacceptable dose or defined as the highest tested dose if no DLT observed at this dose.
Time frame: At Cycle 1 (a cycle is 21 days for Part A and 28 days for Part B) for all patients
Collection of new Adverse Events and follow-up of all ongoing Adverse Events assessed
Adverse Events will be reported and graded based on the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events (AE) \[CTCAE\] scale, version 4.03.
Time frame: At Cycle 1 (at Day 1; Day 3; Day 8; Day 15) and at Cycle 2 (at Day 1; Day 8; Day 15) and at each subsequent cycles in any (at Day 1; Day 8; Day 15) for all patients
Elimination half-life (t1/2) of iv infusions of AsiDNA
The following standard plasma PK parameter for IV AsiDNA will be analyzed: elimination half-life (t1/2) in hours
Time frame: At Cycle 1 (at Day 1; Day 3; Day 8; Day 15) and at cycle 2 (at Day 1) for all patients
ECG evaluation for safety assessment
12-lead ECG will be performed before each cycle (e.g at Day 1 of cycle 1; Day 1 of cycle 2 and Day 1 of each subsequent cycles if any) per usual center's practice.
Time frame: Before each cycle (e.g at Day 1 of cycle 1; Day 1 of cycle 2 and Day 1 of each subsequent cycles if any) per usual center's practice.
Peak plasma concentration of iv infusions of AsiDNA
The following standard plasma PK parameter for IV AsiDNA will be analyzed: peak plasma concentration (Cmax) in ng/mL
Time frame: At Cycle 1 (at Day 1; Day 3; Day 8; Day 15) and at cycle 2 (at Day 1) for all patients
Time to peak plasma concentration of iv infusions of AsiDNA
The following standard plasma PK parameter for IV AsiDNA will be analyzed: time to peak plasma concentration (tmax) in hours
Time frame: At Cycle 1 (at Day 1; Day 3; Day 8; Day 15) and at cycle 2 (at Day 1) for all patients
Area under the curve of iv infusions of AsiDNA
The following standard plasma PK parameter for IV AsiDNA will be analyzed: area under the curve (AUC) in mg\*h/L.
Time frame: At Cycle 1 (at Day 1; Day 3; Day 8; Day 15) and at cycle 2 (at Day 1) for all patients
Accumulation factor based on total plasma exposure of iv infusions of AsiDNA
The following standard plasma PK parameter for IV AsiDNA will be analyzed: accumulation factor between Day 1 and Day 3 based on total plasma exposure.
Time frame: At Cycle 1 (at Day 1) and at cycle 2 (at Day 1) for all patients
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Valerio Therapeutics