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

• ClinicalTrials.gov Identifier: NCT03665129
• Recruitment Status: Recruiting
• First Posted: September 11, 2018
• Last Update Posted: December 23, 2019
• Sponsor: Innate Pharma
• Collaborator: MedImmune LLC
• Information provided by (Responsible Party): Innate Pharma

Tracking Information

• First Submitted Date: September 1, 2018
• First Posted Date: September 11, 2018
• Last Update Posted Date: December 23, 2019
• Actual Study Start Date: September 7, 2018
• Estimated Primary Completion Date: June 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 7, 2018)

• 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)
• Adverse events (AEs) [ Time Frame: From screening visit up to 30 days after the last dose of study medication ]
  To evaluate the safety profile

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 7, 2018)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: IPH5401 (Anti-C5aR) in Combination With Durvalumab in Patients With Advanced Solid Tumors
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Advanced Solid Tumors

Intervention

Biological: IPH5401 and Durvalumab

IPH5401 and durvalumab

Study Arms

• Experimental: Dose escalation
  IPH5401 at different doses and schedule + Durvalumab
  Intervention: Biological: 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
  Intervention: Biological: 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
  Intervention: Biological: 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
  Intervention: Biological: IPH5401 and Durvalumab

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 19, 2019): 140
• Original Estimated Enrollment (submitted: September 7, 2018): 100
• Estimated Study Completion Date: June 2021
• Estimated Primary Completion Date: June 2021 (Final data collection date for primary outcome measure)

Eligibility 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 actionnable 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Emmanuel MITRY, MD;PhD; +33430303030; Emmanuel.MITRY@innate-pharma.fr

Contact: Delphine Marie; Delphine.Marie@innate-pharma.fr

• Listed Location Countries: France, United States

Administrative Information

• NCT Number: NCT03665129
• Other Study ID Numbers: IPH5401-101
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Innate Pharma
• Study Sponsor: Innate Pharma
• Collaborators: MedImmune LLC
• Investigators: Not Provided
• PRS Account: Innate Pharma
• Verification Date: December 2019