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

NCT05117177 | Completed Phase 1 FDA Drug

• 2 other identifiers: A2A-0042020-005861-15
• Study Type: interventional
• Target: 57
• Locations: 2 countries
• Sites: 5

Brief Summary

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.

Conditions

Solid Tumor, Adult

Keywords

Solid Tumor; Advanced Cancers; Phase I; Pharmacokinetics; Safety; Immunotherapy; Adenosine; Inupadenant

Outcome Measures

Primary Outcomes (2)

• Incidence of Dose-Limiting Toxicities (DLTs) in patients with advanced solid tumors receiving inupadenant

  Incidence of adverse events (AEs), serious adverse events (SAEs), DLTs, AEs leading to discontinuation, deaths, electrocardiogram (ECG) abnormalities, and clinically significant laboratory abnormalities

  During the DLT evaluation period that is cycle 1 (each cycle is 4 weeks)

• Incidence and severity of AEs in patients receiving inupadenant

  To assess safety and tolerability as measured by incidence and severity of AEs

  Through study completion, an average of 4 months

Secondary Outcomes (6)

• Plasma concentration of inupadenant vs. time profiles

  Through study completion, an average of 4 months

• Maximum observed serum concentration (Cmax)

  Through study completion, an average of 4 months

• Time of maximum observed concentration (Tmax)

  Through study completion, an average of 4 months

• Area under the concentration-time curve in 1 dosing interval [AUC(TAU)]

  Through study completion, an average of 4 months

• Plasma concentration half-life (T-HALF)

  Through study completion, an average of 4 months

Study Arms (3)

Inupadenant sequential dose escalation (Part 1A)

EXPERIMENTAL

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.

Drug: Inupadenant

Inupadenant randomized crossover (Part 1B)

EXPERIMENTAL

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

Drug: Inupadenant

Inupadenant single treatment assignment (Part 1C)

EXPERIMENTAL

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

Drug: Inupadenant

Interventions

Inupadenant DRUG

Oral administration

Also known as: EOS100850

Inupadenant sequential dose escalation (Part 1A)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• iTeos Therapeutics: lead
• iTeos Belgium SA: collaborator

Study Sites (5)

GZA Ziekenhuizen

Wilrijk, Antwerpen, 2610, Belgium

Location

Cliniques Universitaires St-Luc

Brussels, Brussels Capital, 1200, Belgium

Location

University Hospital Ghent

Ghent, Ghent, 9000, Belgium

Location

Institut Jules Bordet

Anderlecht, 1070, Belgium

Location

Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

Location

Study Officials

• Iteos Clinical Trials

  iTeos Belgium SA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: November 11, 2021
• Study Start: July 1, 2021
• Primary Completion: May 9, 2024
• Study Completion: May 9, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (4); GB (1)