Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03873883
Recruitment Status : Recruiting
First Posted : March 14, 2019
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
iTeos Therapeutics

Tracking Information
First Submitted Date  ICMJE March 6, 2019
First Posted Date  ICMJE March 14, 2019
Last Update Posted Date March 10, 2020
Actual Study Start Date  ICMJE January 28, 2019
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2019)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2019)
  • Plasma concentration of EOS100850 vs. time profiles [ Time Frame: Up to 15 months ]
    Determined by inspection of the concentration-time profile
  • Maximum observed serum concentration (Cmax) [ Time Frame: Up to 15 months ]
    Determined by inspection of the concentration-time profile
  • Time of maximum observed concentration (Tmax) [ Time Frame: Up to 15 months ]
    Determined by inspection of the concentration-time profile
  • 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
  • Plasma concentration half-life (T-HALF) [ Time Frame: Up to 15 month ]
    Determined by inspection of the concentration-time profile
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE First-in-Human Study of EOS100850 in Patients With Cancer
Official Title  ICMJE Phase I/Ib First-in-Human Study of EOS100850 in Patients With Advanced Solid Tumors
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumor, Adult
Intervention  ICMJE Drug: EOS100850
Monotherapy
Study Arms  ICMJE Experimental: Dose Escalation- Monotherapy
Specified EOS100850 dose on specified days
Intervention: Drug: EOS100850
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 9, 2020)
40
Original Estimated Enrollment  ICMJE
 (submitted: March 12, 2019)
18
Estimated Study Completion Date  ICMJE December 1, 2020
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Olivier De Henau +3271919919 IO-001_info@iteostherapeutics.com
Listed Location Countries  ICMJE Belgium,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03873883
Other Study ID Numbers  ICMJE IO-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party iTeos Therapeutics
Study Sponsor  ICMJE iTeos Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account iTeos Therapeutics
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP