IPH5401 (Anti-C5aR) in Combination With Durvalumab in Patients With Advanced Solid Tumors (STELLAR-001)

A Phase I Study of the Anti-C5aR, IPH5401, in Combination With the Anti-PD-L1, Durvalumab, in Patients With Selected Advanced Solid Tumors

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.

Study Overview

• Status: Terminated
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Biological: IPH5401 and Durvalumab

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Dijon, France
    • Centre Georges-François Leclerc
  • Lyon, France, 69373
    • Centre Léon Bérard
  • Marseille, France
    • Hôpital de la Timone- AP-HM
  • Montpellier, France
    • Institut du Cancer de Montpellier
  • Nantes, France
    • Centre Hospitalier Universitaire- Hôpital Nord Laennec
  • Rennes, France
    • Centre Eugène Marquis
  • Villejuif, France
    • Institut Gustave Roussy
• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • James Graham Brown Cancer Center
  • Minnesota
    • Saint Louis Park, Minnesota, United States, 55426
      • Park Nicollet Frauenshuh Cancer Center
  • New York
    • New York, New York, United States, 10029-6574
      • ICAHN School of Medicine at Mount Sinai
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Research Institute
  • Texas
    • San Antonio, Texas, United States, 78006
      • NEXT Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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.
2. At least 18 years of age.
3. ECOG performance status of ≤1.
4. Adequate organ function

Exclusion Criteria:

1. 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)

2. For patient with Hepatocellular carcinoma (HCC):

   1. Hepatic encephalopathy in the past 12 months.
   2. Ascites that requires repeated paracentesis in the past 2 months.
   3. Main portal vein thrombosis.
   4. Active or prior history of gastrointestinal bleeding in the past 12 months.
   5. Prior hepatic transplantation.
3. Patients with known spinal cord compression.
4. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose escalation; IPH5401 at different doses and schedule + Durvalumab	Biological: IPH5401 and Durvalumab; IPH5401 and durvalumab
Experimental: Cohort expansion NSCLC anti-PD-(L)1 pretreated; IPH5401 at recommended dose and schedule + Durvalumab in NSCLC anti-PD-(L)1 pretreated patients	Biological: IPH5401 and Durvalumab; IPH5401 and durvalumab
Experimental: Cohort expansion HCC anti-PD-(L)1 naive; IPH5401 at recommended dose and schedule + Durvalumab in HCC anti-PD-(L)1 naive patients	Biological: IPH5401 and Durvalumab; IPH5401 and durvalumab
Experimental: Cohort expansion HCC anti-PD-(L)1 pretreated; IPH5401 at recommended dose and schedule + Durvalumab in HCC anti-PD-(L)1 pretreated patients	Biological: IPH5401 and Durvalumab; IPH5401 and durvalumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate	Rate of patients in complete or partial response according to RECIST 1.1	up to 12 months
Duration of Response	duration between the complete or partial response and the first documented progression	2 years and 9 months
Progression Free Survival	time between the start of treatment and the first documented progression or death	2 years and 9 months

Collaborators and Investigators

• Sponsor: Innate Pharma
• Collaborators: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2018
• Primary Completion (Actual): February 24, 2021
• Study Completion (Actual): February 24, 2021

Study Registration Dates

• First Submitted: September 1, 2018
• First Submitted That Met QC Criteria: September 7, 2018
• First Posted (Actual): September 11, 2018

Study Record Updates

• Last Update Posted (Actual): January 27, 2022
• Last Update Submitted That Met QC Criteria: January 12, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Anti-Infective Agents; Antiviral Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antineoplastic Agents, Immunological; Durvalumab; Avdoralimab
• Other Study ID Numbers: IPH5401-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No