ZTI-01 100 mg/kg for Acute Lymphoblastic Leukemia (ALL) in Children.

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Acute Lymphoblastic Leukemia (ALL) in Children.ZTI-01 100 mg/kg - Drug
Eligibility
< 18
All Sexes
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Study Summary

This trial is to see what effects a single dose of ZTI-01 has on children under the age of 12, and to compare those effects to adults who have received a 6g dose of the drug. The study will help establish an appropriate dosing for younger children by age cohort.

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 2 Secondary · Reporting Duration: From time end of 1-hour infusion on Day 1, up to 8-12 hours post infusion on Day 1

Day 2
Safety: Treatment Emergent Adverse Events (TEAE)
Day 1
Area under plasma concentration-time curve (AUC) after a single dose of ZTI-01
Maximum concentration (Cmax) after a single dose of ZTI-01

Trial Safety

Safety Progress

1 of 3

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1
isatuximab 10 mg/kg
1
OsrhAAT 1 mg/kg IV
1
DUOC-01

Side Effects for

ZTI-01
9%Alanine aminotransferase increased
7%Aspartate aminotransferase increased
6%Hypokalemia
4%Diarrhea
4%Nausea
4%Vomiting
3%Headache
1%Infusion site phlebitis
This histogram enumerates side effects from a completed 2017 Phase 2 & 3 trial (NCT02753946) in the ZTI-01 ARM group. Side effects include: Alanine aminotransferase increased with 9%, Aspartate aminotransferase increased with 7%, Hypokalemia with 6%, Diarrhea with 4%, Nausea with 4%.

Trial Design

5 Treatment Groups

ZTI-01 Cohort 1 ≥ 6 to <12 years of age
1 of 5
ZTI-01 Cohort 3a Birth to < 3 mos of age
1 of 5
ZTI-01 Cohort 3c ≥ 6 to < 24 mos of age
1 of 5
ZTI-01 Cohort 3b ≥ 3 to < 6 mos of age
1 of 5
ZTI-01 Cohort 2 ≥ 2 to <6 years of age
1 of 5

Experimental Treatment

21 Total Participants · 5 Treatment Groups

Primary Treatment: ZTI-01 100 mg/kg · No Placebo Group · Phase 1

ZTI-01 Cohort 1 ≥ 6 to <12 years of age
Drug
Experimental Group · 1 Intervention: ZTI-01 100 mg/kg · Intervention Types: Drug
ZTI-01 Cohort 3a Birth to < 3 mos of age
Drug
Experimental Group · 1 Intervention: ZTI-01 75 mg/kg · Intervention Types: Drug
ZTI-01 Cohort 3c ≥ 6 to < 24 mos of age
Drug
Experimental Group · 1 Intervention: ZTI-01 100 mg/kg · Intervention Types: Drug
ZTI-01 Cohort 3b ≥ 3 to < 6 mos of age
Drug
Experimental Group · 1 Intervention: ZTI-01 100 mg/kg · Intervention Types: Drug
ZTI-01 Cohort 2 ≥ 2 to <6 years of age
Drug
Experimental Group · 1 Intervention: ZTI-01 100 mg/kg · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from time end of 1-hour infusion on day 1, up to 8-12 hours post infusion on day 1

Who is running the clinical trial?

Nabriva Therapeutics AGLead Sponsor
9 Previous Clinical Trials
2,088 Total Patients Enrolled
John S Bradley, MDPrincipal InvestigatorRady Children's Hospital / Department of Pediatrics, University of California, School of Medicine
Jennifer Schranz, MDStudy ChairNabriva Therapeutics
1 Previous Clinical Trials
551 Total Patients Enrolled

Eligibility Criteria

Age < 18 · All Participants · 5 Total Inclusion Criteria

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