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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-07

Study Completion Date

2021-02-24

Brief Summary

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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.

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Detailed Description

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Conditions

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Advanced Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose escalation

IPH5401 at different doses and schedule + Durvalumab

Group Type EXPERIMENTAL

IPH5401 and Durvalumab

Intervention Type BIOLOGICAL

IPH5401 and durvalumab

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

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

Group Type EXPERIMENTAL

IPH5401 and Durvalumab

Intervention Type BIOLOGICAL

IPH5401 and durvalumab

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

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

Group Type EXPERIMENTAL

IPH5401 and Durvalumab

Intervention Type BIOLOGICAL

IPH5401 and durvalumab

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

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

Group Type EXPERIMENTAL

IPH5401 and Durvalumab

Intervention Type BIOLOGICAL

IPH5401 and durvalumab

Interventions

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IPH5401 and Durvalumab

IPH5401 and durvalumab

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No