First in Human Evaluation of Safety, Pharmacokinetics, and Clinical Activity of a Monoclonal Antibody Targeting Netrin 1 in Patients With Advanced/Metastatic Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

January 9, 2017

Primary Completion Date

December 31, 2021

Study Completion Date

June 30, 2022

Conditions
Advanced Solid TumorEndometrial CarcinomaHormone Receptor Positive
Interventions
DRUG

NP137 DL and RP2D

"DOSE ESCALATION PART: 7 DL: NP137 was administrated every 2 weeks, as single agent by intravenous injection over 90 min with up to 7 ascending dose levels: Dose level 1: 1 mg/kg Dose level 2: 2 mg/kg Dose level 3: 4 mg/kg Dose level 4: 6 mg/kg Dose level 5: 9 mg/kg Dose level 6: 14 mg/kg Dose level 7: 20 mg/kg~EXPANSION PARTS: NP137 was administered every 2 weeks, as single agent by intravenous injection over 180 min at 14 mg/kg (RP2D defined in the Dose escalation part).~FOR ALL PARTS AND COHORT: Treatment will be administered as long as patient experiences clinical benefit in the opinion of the investigator or until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent."

Trial Locations (3)

31059

IUCT-Oncopôle de Toulouse, Toulouse

44805

Ico - Rene Gauducheau, Nantes

69008

Centre Léon Bérard, Lyon

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

NETRIS Pharma

INDUSTRY

lead

Centre Leon Berard

OTHER

NCT02977195 - First in Human Evaluation of Safety, Pharmacokinetics, and Clinical Activity of a Monoclonal Antibody Targeting Netrin 1 in Patients With Advanced/Metastatic Solid Tumors | Biotech Hunter | Biotech Hunter