New Formulation Study of Inupadenant (EOS100850) in Patients with Cancer

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2024-05-09

Brief Summary

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A2A-004 is a three-part multicenter, open-label, Phase I clinical trial intended to evaluate the safety and tolerability, and the pharmacokinetics (PK) and food effect of new formulations of inupadenant (formerly known as EOS100850), in participants with advanced solid tumors.

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Detailed Description

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Conditions

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Solid Tumor, Adult

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Arm 1: sequential dose escalation Arm 2: randomized crossover Arm 3: single treatment assignment

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Inupadenant sequential dose escalation (Part 1A)

Part 1A will evaluate the safety as well as to determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of inupadenant in participants with advanced solid tumors.

Group Type EXPERIMENTAL

Inupadenant

Intervention Type DRUG

Oral administration

Inupadenant randomized crossover (Part 1B)

The effect of food on the exposure to inupadenant will be investigated in participants with advanced solid tumors.

Group Type EXPERIMENTAL

Inupadenant

Intervention Type DRUG

Oral administration

Inupadenant single treatment assignment (Part 1C)

Part 1C will investigate an additional formulation of inupadenant in participants with advanced solid tumors.

Group Type EXPERIMENTAL

Inupadenant

Intervention Type DRUG

Oral administration

Interventions

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Inupadenant

Oral administration

Intervention Type DRUG

Inupadenant

Oral administration

Intervention Type DRUG

Inupadenant

Oral administration

Intervention Type DRUG

Other Intervention Names

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EOS100850 EOS100850 EOS100850

Eligibility Criteria

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Inclusion Criteria

* Women and men ≥18 years of age with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Subject with histologically or cytologically confirmed advanced solid tumor for whom no standard treatment is further available.
* At least 4 weeks since any previous treatment for cancer
* Subject must consent to pretreatment and on treatment tumor biopsies
* Adequate organ and marrow function

Exclusion Criteria

* Patients with primary brain tumors or primary tumors with central nervous system metastases as only location of disease. Controlled brain metastases are permitted
* Participants with second/other active cancers requiring current treatment
* Uncontrolled/significant heart disease
* Known History of chronic hepatitis, Positive test for Hepatitis B virus surface antigen or - - Hepatitis C antibody (except participants with liver cancer) or Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome(HIV/AIDS)
* Active/uncontrolled autoimmune disease
* Active infection

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No