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

iTeos Therapeutics

Status and phase

Completed

Phase 1

Conditions

Solid Tumor, Adult

Treatments

Drug: Inupadenant

Study type

Interventional

Funder types

Industry

Identifiers

NCT05117177

A2A-004

2020-005861-15 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

57 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding participation in the Trial, please refer to your physician

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
Other protocol defined inclusion/exclusion criteria could apply

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

57 participants in 3 patient groups

Inupadenant sequential dose escalation (Part 1A)

Experimental group

Description:

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.

Treatment:

Drug: Inupadenant

Inupadenant randomized crossover (Part 1B)

Experimental group

Description:

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

Treatment:

Drug: Inupadenant

Inupadenant single treatment assignment (Part 1C)

Experimental group

Description:

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