A First-in-Human Study of EOS301984 as Monotherapy or Combination Therapy in Adult Participants With Advanced Solid Tumors
Phase 1
Active, not recruiting
- Conditions
- Advanced Solid Tumors
- Interventions
- 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 55
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
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 Anti-PD-1 monoclonal antibody EOS301984 in combination with other cancer therapies Part 1B dose escalation EOS301984 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 (6)
Grand Hopital de Charleroi
🇧🇪Charleroi, Belgium
Institut Jules Bordet
🇧🇪Brussels, Belgium
Cliniques Universitaires Saint-Luc
🇧🇪Brussels, Belgium
Universitair Ziekenhuis Gent
🇧🇪Ghent, Belgium
CHU de Liège
🇧🇪Liège, Belgium
GZA Ziekenhuizen campus Sint-Augustinus
🇧🇪Wilrijk, Belgium
Grand Hopital de Charleroi🇧🇪Charleroi, Belgium