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

Innate Pharma

Status and phase: Terminated; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Biological: IPH5401 and Durvalumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03665129

IPH5401-101

Details and patient eligibility

About

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.

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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73 participants in 4 patient groups

Dose escalation

Experimental group

Description:

IPH5401 at different doses and schedule + Durvalumab

Treatment:

Biological: IPH5401 and Durvalumab

Cohort expansion NSCLC anti-PD-(L)1 pretreated

Experimental group

Description:

IPH5401 at recommended dose and schedule + Durvalumab in NSCLC anti-PD-(L)1 pretreated patients

Treatment:

Biological: IPH5401 and Durvalumab

Cohort expansion HCC anti-PD-(L)1 naive

Experimental group

Description:

IPH5401 at recommended dose and schedule + Durvalumab in HCC anti-PD-(L)1 naive patients

Treatment:

Biological: IPH5401 and Durvalumab

Cohort expansion HCC anti-PD-(L)1 pretreated

Experimental group

Description:

IPH5401 at recommended dose and schedule + Durvalumab in HCC anti-PD-(L)1 pretreated patients

Treatment:

Biological: IPH5401 and Durvalumab