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

• ClinicalTrials.gov Identifier: NCT03665129
• Recruitment Status: Active, not recruiting
• First Posted: September 11, 2018
• Last Update Posted: January 22, 2021
• Sponsor: Innate Pharma
• Collaborator: AstraZeneca
• Information provided by (Responsible Party): Innate Pharma

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Advanced Solid Tumors	Biological: IPH5401 and Durvalumab	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 73 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase I Study of the Anti-C5aR, IPH5401, in Combination With the Anti-PD-L1, Durvalumab, in Patients With Selected Advanced Solid Tumors
• Actual Study Start Date: September 7, 2018
• Estimated Primary Completion Date: June 2021
• Estimated Study Completion Date: June 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Occurrence of Drug Limited Toxicities (DLTs) [ Time Frame: From Time of First dose assessed up to 6 weeks ]
   To assess the occurrence of Drug Limited Toxicities (DLTs)
2. Adverse events (AEs) [ Time Frame: From screening visit up to 30 days after the last dose of study medication ]
   To evaluate the safety profile

Secondary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, Kentucky

James Graham Brown Cancer Center

Louisville, Kentucky, United States, 40202

United States, Minnesota

Park Nicollet Frauenshuh Cancer Center

Saint Louis Park, Minnesota, United States, 55426

United States, New York

ICAHN School of Medicine at Mount Sinai

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

United States, Tennessee

Sarah Cannon Research Institute

Nashville, Tennessee, United States, 37203

United States, Texas

NEXT Oncology

San Antonio, Texas, United States, 78006

France

Centre Georges-Francois Leclerc

Dijon, France

Centre Leon Berard

Lyon, France, 69373

Hôpital de la Timone- AP-HM

Marseille, France

Institut du Cancer de Montpellier

Montpellier, France

Centre Hospitalier Universitaire- Hôpital Nord Laennec

Nantes, France

Centre Eugène Marquis

Rennes, France

Institut Gustave Roussy

Villejuif, France

Sponsors and Collaborators

Innate Pharma

AstraZeneca

More Information

• Responsible Party: Innate Pharma
• ClinicalTrials.gov Identifier: NCT03665129
• Other Study ID Numbers: IPH5401-101
• First Posted: September 11, 2018
• Last Update Posted: January 22, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Neoplasms; Durvalumab; Antineoplastic Agents, Immunological; Antineoplastic Agents