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

Advanced Solid Tumors Clinical Trial

— STELLAR-001  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03665129
• Other study ID #: IPH5401-101
• Status: Terminated
• Phase: Phase 1
• Start date: September 7, 2018
• Est. completion date: February 24, 2021

Study information

• Verified date: January 2022
• Source: Innate Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 73
• Est. completion date: February 24, 2021
• Est. primary completion date: February 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Biological:
• IPH5401 and Durvalumab
IPH5401 and durvalumab

Locations

Country	Name	City	State
France	Centre Georges-Francois Leclerc	Dijon
France	Centre Leon Berard	Lyon
France	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
United States	James Graham Brown Cancer Center	Louisville	Kentucky
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	ICAHN School of Medicine at Mount Sinai	New York	New York
United States	Park Nicollet Frauenshuh Cancer Center	Saint Louis Park	Minnesota
United States	NEXT Oncology	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Innate Pharma	AstraZeneca

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Adverse events (AEs)	To evaluate the safety profile	From screening visit up to 30 days after the last dose of study medication
Secondary	Objective Response Rate	Rate of patients in complete or partial response according to RECIST 1.1	up to 12 months
Secondary	Duration of Response	duration between the complete or partial response and the first documented progression	2 years and 9 months
Secondary	Progression Free Survival	time between the start of treatment and the first documented progression or death	2 years and 9 months