NCT03665129

Brief Summary

This is a multicenter, open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, antitumor activity of IPH5401 (anti C5aR) in combination with Durvalumab (MEDI4736) in Adult Subjects with selected advanced solid tumors.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2018

Typical duration for phase_1

Geographic Reach
2 countries

12 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

September 7, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 11, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2021

Completed
Last Updated

January 27, 2022

Status Verified

January 1, 2022

Enrollment Period

2.5 years

First QC Date

September 1, 2018

Last Update Submit

January 12, 2022

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

  • Occurrence of Drug Limited Toxicities (DLTs)

    To assess the occurrence of Drug Limited Toxicities (DLTs)

    From Time of First dose assessed up to 6 weeks

  • Adverse events (AEs)

    To evaluate the safety profile

    From screening visit up to 30 days after the last dose of study medication

Secondary Outcomes (3)

  • Objective Response Rate

    up to 12 months

  • Duration of Response

    2 years and 9 months

  • Progression Free Survival

    2 years and 9 months

Study Arms (4)

Dose escalation

EXPERIMENTAL

IPH5401 at different doses and schedule + Durvalumab

Biological: IPH5401 and Durvalumab

Cohort expansion NSCLC anti-PD-(L)1 pretreated

EXPERIMENTAL

IPH5401 at recommended dose and schedule + Durvalumab in NSCLC anti-PD-(L)1 pretreated patients

Biological: IPH5401 and Durvalumab

Cohort expansion HCC anti-PD-(L)1 naive

EXPERIMENTAL

IPH5401 at recommended dose and schedule + Durvalumab in HCC anti-PD-(L)1 naive patients

Biological: IPH5401 and Durvalumab

Cohort expansion HCC anti-PD-(L)1 pretreated

EXPERIMENTAL

IPH5401 at recommended dose and schedule + Durvalumab in HCC anti-PD-(L)1 pretreated patients

Biological: IPH5401 and Durvalumab

Interventions

IPH5401 and DurvalumabBIOLOGICAL

IPH5401 and durvalumab

Cohort expansion HCC anti-PD-(L)1 naiveCohort expansion HCC anti-PD-(L)1 pretreatedCohort expansion NSCLC anti-PD-(L)1 pretreatedDose escalation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with advanced and/or metastatic histologically solid tumors with evidence of active disease, who have been treated with a minimum of one line of systemic therapy in the metastatic setting, and in expansion part, no more than two prior systemic therapies.
  • At least 18 years of age.
  • ECOG performance status of ≤1.
  • Adequate organ function

You may not qualify if:

  • For patients with Non Small Cell Lung Cancer (NSCLC):
  • a. Known actionable mutation or rearrangement (including but not limited to the epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) gene rearrangements, ROS-1 alterations or BRAF mutations)
  • For patient with Hepatocellular carcinoma (HCC):
  • Hepatic encephalopathy in the past 12 months.
  • Ascites that requires repeated paracentesis in the past 2 months.
  • Main portal vein thrombosis.
  • Active or prior history of gastrointestinal bleeding in the past 12 months.
  • Prior hepatic transplantation.
  • Patients with known spinal cord compression.
  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Park Nicollet Frauenshuh Cancer Center

Saint Louis Park, Minnesota, 55426, United States

Location

ICAHN School of Medicine at Mount Sinai

New York, New York, 10029-6574, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

NEXT Oncology

San Antonio, Texas, 78006, United States

Location

Centre Georges-Francois Leclerc

Dijon, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Hôpital de la Timone- AP-HM

Marseille, France

Location

Institut du Cancer de Montpellier

Montpellier, France

Location

Centre Hospitalier Universitaire- Hôpital Nord Laennec

Nantes, France

Location

Centre Eugène Marquis

Rennes, France

Location

Institut Gustave Roussy

Villejuif, France

Location

MeSH Terms

Interventions

avdoralimabdurvalumab

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2018

First Posted

September 11, 2018

Study Start

September 7, 2018

Primary Completion

February 24, 2021

Study Completion

February 24, 2021

Last Updated

January 27, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(7)US(5)