Clinical Trials /

First-in-Human Study of EOS100850 in Patients With Cancer

NCT03873883

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: First-in-Human Study of EOS100850 in Patients With Cancer
  • Official Title: Phase I/Ia 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

  • Solid Tumor, Adult

Interventions

DrugSynonymsArms
EOS100850Dose Escalation- Monotherapy
PembrolizumabKeytruda, MK-3475EOS100850 and Pembrolizumab Combination Therapy
ChemotherapyEOS100850 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

NameTypeDescriptionInterventions
Dose Escalation- MonotherapyExperimentalSpecified dose on specified days
  • EOS100850
EOS100850 and Pembrolizumab Combination TherapyExperimentalSpecified dose on specified days
  • EOS100850
  • Pembrolizumab
EOS100850 and SOC Combination ChemotherapyExperimentalSpecified EOS100850 dose on specified days
  • EOS100850
  • Chemotherapy

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

October 6, 2020