Description:
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 as a Single Agent and in Combination with Pembrolizumab and/or
Chemotherapy in Participants with Advanced Cancers.
Title
- Brief Title: First-in-Human Study of EOS100850 in Patients With Cancer
- Official Title: Phase I/Ib First-in-Human Study of EOS100850 as a Single Agent and in Combination With Pembrolizumab and/or Chemotherapy in Participants With Advanced Cancers
Clinical Trial IDs
- ORG STUDY ID:
IO-001
- SECONDARY ID:
Keynote A45
- NCT ID:
NCT03873883
Conditions
Interventions
Drug | Synonyms | Arms |
---|
EOS100850 | | Dose Escalation- Monotherapy |
Pembrolizumab | Keytruda, MK-3475 | EOS100850 and Pembrolizumab Combination Therapy |
Chemotherapy | | EOS100850 and SOC Combination Chemotherapy |
Purpose
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 as a Single Agent and in Combination with Pembrolizumab and/or
Chemotherapy in Participants with Advanced Cancers.
Trial Arms
Name | Type | Description | Interventions |
---|
Dose Escalation- Monotherapy | Experimental | Specified dose on specified days | |
EOS100850 and Pembrolizumab Combination Therapy | Experimental | Specified dose on specified days | |
EOS100850 and SOC Combination Chemotherapy | Experimental | Specified EOS100850 dose on specified days | |
Eligibility Criteria
For more information regarding participation in the Trial, please refer to your physician
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Other protocol defined inclusion/exclusion criteria could apply
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence of Dose-Limiting Toxicities (DLTs) in patients with advanced solid tumors receiving EOS100850 |
Time Frame: | Up to 15 months |
Safety Issue: | |
Description: | To define the maximum tolerated dose (MTD) or the recommended Phase 2 dose (RP2D) of EOS100850 in patients receiving EOS100850 |
Secondary Outcome Measures
Measure: | Plasma concentration of EOS100850 vs. time profiles |
Time Frame: | Up to 15 months |
Safety Issue: | |
Description: | Determined by inspection of the concentration-time profile |
Measure: | Maximum observed serum concentration (Cmax) |
Time Frame: | Up to 15 months |
Safety Issue: | |
Description: | Determined by inspection of the concentration-time profile |
Measure: | Time of maximum observed concentration (Tmax) |
Time Frame: | Up to 15 months |
Safety Issue: | |
Description: | Determined by inspection of the concentration-time profile |
Measure: | Area under the concentration-time curve in 1 dosing interval [AUC(TAU)] |
Time Frame: | Up to 15 month |
Safety Issue: | |
Description: | Determined by inspection of the concentration-time profile |
Measure: | Plasma concentration half-life (T-HALF) |
Time Frame: | Up to 15 month |
Safety Issue: | |
Description: | Determined by inspection of the concentration-time profile |
Measure: | Overall response rate per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 |
Time Frame: | Up to 15 month |
Safety Issue: | |
Description: | Assessment of preliminary efficacy of EOS100850 |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | iTeos Therapeutics |
Last Updated
December 2, 2020