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

• Sponsor: Innate Pharma (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03665129
• Collaborator: AstraZeneca (Industry)
• Enrollment: 73
• Locations: 12
• Arms: 4
• Actual Duration (Months): 29.6
• Patients Per Site: 6.1
• Patients Per Site Per Month: 0.2

Study Details

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
• 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: Sep 7, 2018
• Actual Primary Completion Date: Feb 24, 2021
• Actual Study Completion Date: Feb 24, 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) [From Time of First dose assessed up to 6 weeks]

   To assess the occurrence of Drug Limited Toxicities (DLTs)

2. Adverse events (AEs) [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 [up to 12 months]

   Rate of patients in complete or partial response according to RECIST 1.1

2. Duration of Response [2 years and 9 months]

   duration between the complete or partial response and the first documented progression

3. Progression Free Survival [2 years and 9 months]

   time between the start of treatment and the first documented progression or death

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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):

1. 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)

1. For patient with Hepatocellular carcinoma (HCC):

2. Hepatic encephalopathy in the past 12 months.

3. Ascites that requires repeated paracentesis in the past 2 months.

4. Main portal vein thrombosis.

5. Active or prior history of gastrointestinal bleeding in the past 12 months.

6. Prior hepatic transplantation.

7. Patients with known spinal cord compression.

8. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	James Graham Brown Cancer Center	Louisville	Kentucky	United States	40202
2	Park Nicollet Frauenshuh Cancer Center	Saint Louis Park	Minnesota	United States	55426
3	ICAHN School of Medicine at Mount Sinai	New York	New York	United States	10029-6574
4	Sarah Cannon Research Institute	Nashville	Tennessee	United States	37203
5	NEXT Oncology	San Antonio	Texas	United States	78006
6	Centre Georges-Francois Leclerc	Dijon		France
7	Centre Leon Berard	Lyon		France	69373
8	Hôpital de la Timone- AP-HM	Marseille		France
9	Institut du Cancer de Montpellier	Montpellier		France
10	Centre Hospitalier Universitaire- Hôpital Nord Laennec	Nantes		France
11	Centre Eugène Marquis	Rennes		France
12	Institut Gustave Roussy	Villejuif		France

Sponsors and Collaborators

• Innate Pharma
• AstraZeneca

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Innate Pharma
• ClinicalTrials.gov Identifier: NCT03665129
• Other Study ID Numbers: IPH5401-101
• First Posted: Sep 11, 2018
• Last Update Posted: Jan 27, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• 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; Avdoralimab; Durvalumab

Study Results

No Results Posted as of Jan 27, 2022