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

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ClinicalTrials.gov Identifier: NCT03873883
Recruitment Status : Recruiting
First Posted : March 14, 2019
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
iTeos Therapeutics

Brief Summary:
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 in patients with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Solid Tumor, Adult Drug: EOS100850 Phase 1

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Study Type : Interventional
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/Ib First-in-Human Study of EOS100850 in Patients With Advanced Solid Tumors
Actual Study Start Date : January 28, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : December 1, 2020

Arm Intervention/treatment
Experimental: Dose Escalation- Monotherapy
Specified EOS100850 dose on specified days
Drug: EOS100850
Monotherapy




Primary Outcome Measures :
  1. Incidence of Dose-Limiting Toxicities (DLTs) in patients with advanced solid tumors receiving EOS100850 [ Time Frame: Up to 15 months ]
    To define the maximum tolerated dose (MTD) or the recommended Phase 2 dose (RP2D) of EOS100850 in patients receiving EOS100850

  2. Incidence and severity of AEs in patients receiving EOS100850 [ Time Frame: Up to 15 months ]
    To assess safety and tolerability as measured by incidence and severity of AEs


Secondary Outcome Measures :
  1. Plasma concentration of EOS100850 vs. time profiles [ Time Frame: Up to 15 months ]
    Determined by inspection of the concentration-time profile

  2. Maximum observed serum concentration (Cmax) [ Time Frame: Up to 15 months ]
    Determined by inspection of the concentration-time profile

  3. Time of maximum observed concentration (Tmax) [ Time Frame: Up to 15 months ]
    Determined by inspection of the concentration-time profile

  4. Area under the concentration-time curve in 1 dosing interval [AUC(TAU)] [ Time Frame: Up to 15 month ]
    Determined by inspection of the concentration-time profile

  5. Plasma concentration half-life (T-HALF) [ Time Frame: Up to 15 month ]
    Determined by inspection of the concentration-time profile

  6. Overall response rate per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 [ Time Frame: Up to 15 month ]
    Assessment of preliminary efficacy of EOS100850



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03873883


Contacts
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Contact: Olivier De Henau +3271919919 IO-001_info@iteostherapeutics.com

Locations
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Belgium
UCL-St Luc Recruiting
Brussels, Belgium
Contact: Jean-Pascal Machiels         
ULB-Bordet Recruiting
Brussels, Belgium
Contact: Laurence Buisseret         
UZ Ghent Recruiting
Ghent, Belgium
Contact: Sylvie Rottey         
Sponsors and Collaborators
iTeos Therapeutics

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Responsible Party: iTeos Therapeutics
ClinicalTrials.gov Identifier: NCT03873883     History of Changes
Other Study ID Numbers: IO-001
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No