Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors

Lung Cancer Clinical Trial

— TIG-006  

Official title:

A Multicenter, Open-Label, Phase I/II Study of EOS884448 (EOS-448) in Combination With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05060432
• Other study ID #: TIG-006
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 6, 2021
• Est. completion date: January 2025

Study information

• Verified date: December 2023
• Source: iTeos Therapeutics
• Contact: iTeos Belgium SA
• Phone: +32 71 91 99 33
• Email: clinical_info[@]iteostherapeutics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multicenter, open-label, phase I/II basket study, evaluating the safety, tolerability, RP2D, pharmacokinetics, pharmacodynamics and antitumor activity of EOS-448 (also known as GSK4428859A or belrestotug) combined with standard of care and/or with investigational therapies in participants with advanced solid tumors.

Description:

The combinations evaluated will be: - EOS-448 combined with pembrolizumab, an anti-PD-1 antibody - EOS-448 combined with inupadenant an investigational adenosine A2A receptor antagonist - EOS-448 combined with dostarlimab an anti-PD-1 antibody - inupadenant combined with dostarlimab - EOS-448 combined with inupadenant and dostarlimab - EOS-448 combined with dostarlimab and standard of care chemotherapies in participants with NSCLC

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 254
• Est. completion date: January 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Provide a signed written informed consent for the trial
• Have measurable disease, per RECIST v1.1
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of Grade 0 or 1.
• Have adequate organ functions
• Part 1A/1B/1C/1D/1E/1F: Have histologically or cytologically confirmed advanced or metastatic solid tumor for whom no standard treatment with survival benefit is available

Part 1G (NSCLC):

• Have a histologically confirmed or cytologically confirmed previously untreated stage IV OR stage III not amenable to curative chemoradiotherapy or surgery (AJCC 8th edition) nonsquamous NSCLC OR squamous NSCLC.
• Are eligible to receive anti-PD(L)1 therapy combined with chemotherapy in first line metastatic setting Part 2 (H&N cancer)
• Have histologically or cytologically confirmed recurrent advanced or metastatic head and neck squamous cell carcinoma considered incurable by local therapies
• PD-L1 status positive

Exclusion Criteria:

• Have received any anti-cancer therapy within 4 weeks prior to the first dose
• Have received a live vaccine within 30 days prior to the first dose
• Have known primary CNS cancer.
• Have known CNS metastases unless previously treated and well controlled for at least 1 month
• Have concomitant second malignancies unless a complete remission was achieved at least 2 years before study entry
• Have a history of Grade = 2 pneumonitis, active autoimmune disease, or persistent immune-mediated toxicity caused by immune checkpoint inhibitor therapy of Grade = 2
• Have toxicity (except for alopecia) related to prior anti-cancer therapy and/or surgery unless the toxicity is either resolved, returned to baseline or Grade 1, or deemed irreversible.
• Have uncontrolled or significant cardiovascular disease
• Part 1: major surgery within 3 weeks before initiating treatment
• Part 1: Have received prior radiotherapy within 2 weeks of start of study treatment
• Part 2 (H&N cancer):
• Have received prior immunotherapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
• Have received prior chemotherapy administered in the recurrent advanced or metastatic setting (except for systemic therapy completed > 6 months prior to screening if given as part of multimodal treatment for locally advanced disease)

Related Conditions & MeSH terms

• Advanced Cancer
• Head and Neck Cancer
• Head and Neck Neoplasms
• Lung Cancer
• Melanoma

Intervention

Drug:
• EOS-448
Anti-TIGIT monoclonal antibody
• pembrolizumab
Anti-PD-1 monoclonal antibody
• inupadenant
A2A receptor antagonist
• Dostarlimab
Anti-PD-1 monoclonal antibody
• SOC chemotherapies
SOC chemotherapies in 1L mNSCLC

Locations

Country	Name	City	State
Belgium	GZA Ziekenhuizen campus Sint-Augustinus	Antwerpen	Antwerp
Belgium	Cliniques universitaires St Luc-UCL	Brussels
Belgium	Jessa Ziekenhuis	Hasselt
Belgium	UZ Leuven	Leuven
France	Hôpital Saint André	Bordeaux
France	CHU Caen	Caen
France	Centre Georges Francois Leclerc	Dijon
France	Clinique Victor Hugo	Le Mans
France	Centre Léon Bérard	Lyon
France	Institut de Cancérologie de l'Ouest	Nantes
France	Centre Antoine Lacassagne	Nice
France	Pitié Salpêtrière	Paris
France	CHU de POITIERS	Poitiers
France	ICANS	Strasbourg
Italy	Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRCCS (Meldola)	Meldola
Italy	Istituto Europeo di Oncologia	Milano
Italy	Universita degli Studi di Pavia - Fondazione IRCCS Policlinico San Matteo	Pavia
Spain	Hospital Universitario de Badajoz	Badajoz
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	UOMI Cancer Center-Clinica Tres Torres	Barcelona
Spain	Vall d'Hebron	Barcelona
Spain	Consorcio Hospitalario Provincial de Castello	Castelló
Spain	Hospital Universitario de Jaen	Jaén
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Fundación Jiménez Díaz	Madrid
Spain	Hospital Universitario Puerta de Hierro de Majadahonda	Majadahonda
Spain	Hospital Universitario de Navarra	Pamplona
Spain	Hospital Universitario de Navarra (Pamplona)	Pamplona
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)	Valencia
United Kingdom	Hammersmith Hospital	London
United States	Hackensack University Medical Center	Bergen	New Jersey
United States	The Gabrail Pharmacology Phase 1 Research Center LLC	Canton	Ohio
United States	Clermont Oncology Center	Clermont	Florida
United States	University of Kentucky, Markey Cancer Center	Lexington	Kentucky
United States	Norton Cancer Institute	Louisville	Kentucky
United States	Alpha Oncology Research	Orange City	Florida
United States	University of Pittsburg Medical Center	Pittsburgh	Pennsylvania
United States	University of California San Diego	San Diego	California
United States	Innovative Clinical Research Institute, LLC	Whittier	California

Sponsors (3)

Lead Sponsor	Collaborator
iTeos Belgium SA	GlaxoSmithKline, iTeos Therapeutics

Countries where clinical trial is conducted

United States,  Belgium,  France,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with DLT and Adverse Events		From first study treatment administration through Day 21-28 for DLT / Up to 120 days after the last dose
Primary	Recommended Phase 2 dose (RP2D) of EOS884448 in participants with advanced solid tumors		Up to 48 weeks
Primary	Percentage of participants with Objective Response as determined by Investigator		Until disease progression - Approximately 48 months
Secondary	Duration of Response (DOR)		Until disease progression or death - Approximately 48 months
Secondary	Disease Control Rate (DCR)		Until disease progression or death - Approximately 48 months
Secondary	Progression-free-survival (PFS)		Until disease progression or death - Approximately 48 months
Secondary	Mean and median Maximum concentration (Cmax) of EOS884448 at each dose level		Up to 48 weeks
Secondary	Percentage of participants with anti-drug antibodies to EOS884448		Up to 48 weeks