First-in-Human Study of EOS100850 (Inupadenant) in Patients with Cancer

NCT03873883 | Completed Phase 1 FDA Drug

• 3 other identifiers: IO-0012018-003173-10Keynote A45
• Study Type: interventional
• Target: 119
• Locations: 6 countries
• Sites: 19

Brief Summary

Multicenter, open-label, dose-escalation Phase I/Ib clinical study to evaluate the safety and tolerability, the MTD/RP2D, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of EOS100850 (Inupadenant) as a Single Agent and in Combination with Pembrolizumab and/or Chemotherapy in Participants with Advanced Cancers.

Conditions

Solid Tumor, Adult

Keywords

solid; tumor; advanced cancers; pharmacokinetics; safety; inupadenant; pembrolizumab; chemotherapy

Outcome Measures

Primary Outcomes (2)

• Incidence of Dose-Limiting Toxicities (DLTs) in patients with advanced solid tumors receiving EOS100850

  To define the maximum tolerated dose (MTD) or the recommended Phase 2 dose (RP2D) of EOS100850 in patients receiving EOS100850

  During the DLT evaluation period that is cycle 1 (each cycle is 3 or 4 weeks)

• Incidence and severity of AEs in patients receiving EOS100850

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

  Up to 30 months

Secondary Outcomes (6)

• Plasma concentration of EOS100850 vs. time profiles

  Up to 30 months

• Maximum observed serum concentration (Cmax)

  Up to 30 months

• Time of maximum observed concentration (Tmax)

  Up to 30 months

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

  Up to 30 months

• Plasma concentration half-life (T-HALF)

  Up to 30 months

Study Arms (6)

1A Dose escalation EOS100850

EXPERIMENTAL

Dose Escalation- EOS100850 Monotherapy: to confirm RP2D

Drug: EOS100850

1B Dose escalation EOS100850 and Pembrolizumab

EXPERIMENTAL

EOS100850 and Pembrolizumab Combination Therapy: to confirm RP2D as combination

Drug: EOS100850; Drug: Pembrolizumab

2A Dose Expansion- EOS100850

EXPERIMENTAL

Dose Expansion - EOS100850 Monotherapy: to explore safety, PK, PD, and antitumor activity of inupadenant as monotherapy

Drug: EOS100850

2B Dose Expansion - EOS100850 and Pembrolizumab

EXPERIMENTAL

Dose Expansion - EOS100850 and Pembrolizumab Combination Therapy: to explore safety, PK, PD, and antitumor activity of inupadenant in combination with pembrolizumab in melanoma and CRPC patients

Drug: EOS100850; Drug: Pembrolizumab

2D Dose expansion - EOS100850 and Chemotherapy in TNBC

EXPERIMENTAL

Dose expansion - EOS100850 and Chemotherapy Combination: to explore safety, PK, PD, and antitumor activity of inupadenant in combination with chemotherapy SOC carboplatin and paclitaxel in patients with TNBC

Drug: EOS100850; Drug: Chemotherapy

3 EOS100850 in BMK-H participants

EXPERIMENTAL

Dose expansion - EOS100850 Monotherapy : to evaluate the safety, PD, and antitumor activity of inupadenant as monotherapy at the mono-RP2D in BMK-H participants in 4 disease-specific cohorts: NSCLC; HNSCC; EC; and other forms of cancer

Drug: EOS100850

Interventions

EOS100850 DRUG

Oral administration

Also known as: Inupadenant

1A Dose escalation EOS100850; 1B Dose escalation EOS100850 and Pembrolizumab; 2A Dose Expansion- EOS100850; 2B Dose Expansion - EOS100850 and Pembrolizumab; 2D Dose expansion - EOS100850 and Chemotherapy in TNBC; 3 EOS100850 in BMK-H participants

Pembrolizumab DRUG

IV Infusion

Also known as: Keytruda, MK-3475

1B Dose escalation EOS100850 and Pembrolizumab; 2B Dose Expansion - EOS100850 and Pembrolizumab

Chemotherapy DRUG

Standard of Care IV Infusion

Also known as: carboplatin and paclitaxel

2D Dose expansion - EOS100850 and Chemotherapy in TNBC

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
• Merck Sharp & Dohme LLC: collaborator

Study Sites (19)

Karmanos Cancer Institute

Michigan Center, Michigan, 48201, United States

Location

John Theurer Cancer Center, Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229-3900, United States

Location

Hospital GZA Sint-Augustinus

Wilrijk, Antwerpen, 2610, Belgium

Location

Institut Jules Bordet

Anderlecht, Brussels Capital, 1070, Belgium

Location

UCL Saint-Luc

Brussels, Brussels Capital, 1200, Belgium

Location

UZ Ghent

Ghent, East-Flanders, 9000, Belgium

Location

Centre de Lutte Contre le Cancer (CLCC) - Universite de Lyon - Centre Leon-Berard

Lyon, 69008, France

Location

Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie- Pôle Régional de Cancérologie

Poitiers, 86021, France

Location

Centre de Lutte Contre le Cancer - Institut de Cancerologie de l'Ouest - Rene Gauducheau

Saint-Herblain, 44805, France

Location

Gustave Roussy

Villejuif, 94805, France

Location

Yonsei University Severance Hospital

Seoul, 03722, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

St Mary's Hospital, The Catholic University of Korea

Seoul, 06591, South Korea

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

START Madrid-HM CIOCC Hospital Universitario HM Sanchinarro

Madrid, 28050, Spain

Location

Universidad de Navarra - Clinica Universitaria de Navarra

Pamplona, 31008, Spain

Location

Onkologikoa

San Sebastián, 20014, Spain

Location

The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital

Sutton, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Interventions

pembrolizumab; Drug Therapy; Carboplatin; Paclitaxel

Intervention Hierarchy (Ancestors)

Therapeutics; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

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

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: March 14, 2019
• Study Start: February 5, 2019
• Primary Completion: May 28, 2024
• Study Completion: May 28, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-07

Locations

US (3); BE (4); ES (4); KR (3); GB (1); FR (4)