A First-in-Human Study of EOS301984 as Monotherapy or Combination Therapy in Adult Participants With Advanced Solid Tumors

Phase 1

Recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Drug: EOS301984; Drug: Anti-PD-1 monoclonal antibody

• Registration Number: NCT06547957
• Lead Sponsor: iTeos Therapeutics

Brief Summary

APT-008 is an open-label, Phase I/Ib, dose escalation and expansion cohort study to evaluate the safety, tolerability, Pharmacokinetic (PK), Pharmacodynamic (PD), and preliminary efficacy of EOS301984 as monotherapy and in combination with other anticancer therapies in participants with advanced solid tumors.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-07
• Study First Submitted: 2024-03-28
• Status Verified: 2024-07
• Study First Submitted QC: 2024-08-07
• Last Update Submitted: 2024-08-07
• Study First Posted: 2024-08-09
• Last Update Posted: 2024-08-09
• Primary Completion: 2025-10
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part 1A dose escalation	EOS301984	EOS301984 dose escalation as monotherapy
Part 1B dose escalation	EOS301984	EOS301984 in combination with other cancer therapies
Part 1B dose escalation	Anti-PD-1 monoclonal antibody	EOS301984 in combination with other cancer therapies

Primary Outcome Measures

Name	Time	Method
To characterize the safety and tolerability of EOS301984 alone and in combination with other anticancer agents in participants with advanced solid tumors	From first study treatment administration to last participant last follow-up (Up to 4 years)
Incidence and severity of AEs in patients receiving EEOS301984	From first study treatment administration to last participant last follow-up (Up to 4 years)

Secondary Outcome Measures

Name	Time	Method
Percentage of participants with Objective Response as determined by Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1	From first study treatment administration to last participant last follow-up (Up to 4 years)
Mean and median Maximum concentration (Cmax) of EOS301984 following first dose and repeated administration at each dose level	From first dose up to 21 days repeated cycles
Mean and median Area under the curve (AUC) of EOS301984 following first dose and repeated administration at each dose level	From first dose up to 21 days repeated cycles
Define the recommended Phase 2 dose (RP2D) in participants with advanced tumors.	From first study treatment administration to last participant last follow-up (Up to 4 years)

Trial Locations

Locations (5)

Institut Jules Bordet; 🇧🇪 Brussels, Belgium

CHU de Liège; 🇧🇪 Liège, Belgium

Universitair Ziekenhuis Gent; 🇧🇪 Ghent, Belgium

Cliniques Universitaires Saint-Luc; 🇧🇪 Brussels, Belgium

GZA Ziekenhuizen campus Sint-Augustinus; 🇧🇪 Wilrijk, Belgium