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Trial record 1 of 1 for:    04335253
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First-In-Human Study of EOS884448 in Participants With Advanced Cancers.

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: NCT04335253
Recruitment Status : Recruiting
First Posted : April 6, 2020
Last Update Posted : April 6, 2020
Sponsor:
Information provided by (Responsible Party):
iTeos Therapeutics

Brief Summary:
IO-002 study is a multicenter, open-label, dose-escalation Phase I/IIa clinical study to evaluate the safety and tolerability, PK, PD, and antitumor activity of EOS884448 in participants with advanced cancers.

Condition or disease Intervention/treatment Phase
Advanced Cancer Drug: EOS884448 Phase 1

Detailed Description:
Multicenter, open-label, dose-escalation Phase I/IIa clinical study to evaluate the safety and tolerability, PK, PD, and antitumor activity of EOS884448 in participants with advanced cancers. The study will be conducted in 2 parts. The first part is a dose-escalation to determine the MTD, the RP2D, and the safety of EOS884448 in participants with advanced cancers. The subsequent expansion part will further explore safety, PK, PD responses, and antitumor activity of EOS884448 at the RP2D as monotherapy in participants with selected cancer types.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/IIa First-In-Human Study of EOS884448 in Participants With Advanced Cancers.
Actual Study Start Date : February 18, 2020
Estimated Primary Completion Date : April 5, 2021
Estimated Study Completion Date : June 30, 2021

Arm Intervention/treatment
Experimental: Multiple Ascending Dose
Dose escalation according to cohort allocation
Drug: EOS884448
Multiple Ascending Dose
Other Name: EOS-448




Primary Outcome Measures :
  1. Percentage of participants with Adverse Events [ Time Frame: From first dose date to 90 days after the last dose (up to 48 weeks) ]
  2. Percentage of participants who experience a Dose Limiting Toxicity [ Time Frame: From first study treatment administration through Day 28 ]
  3. Define the recommended Phase 2 dose (RP2D) of EOS884448 in participants with advanced tumors. [ Time Frame: up to 48 weeks ]

Secondary Outcome Measures :
  1. Mean and median Area under the curve (AUC) of EOS884448 at each dose level [ Time Frame: up to 48 weeks ]
  2. Mean and median Maximum concentration (Cmax) of EOS884448 at each dose level [ Time Frame: up to 48 weeks ]
  3. Percentage of participants with Objective Response as determined by Investigator according to RECIST v1.1or per other specific response criteria according to their tumor type. [ Time Frame: From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 48 weeks) ]
  4. Percentage of participants with anti-drug antibodies to EOS884448 [ Time Frame: Recorded at baseline (screening), during the first 4 cycles of treatment (4 months), at end of treatment, and 30 and 90 days post last dose (approximately 48 weeks) ]


Information from the National Library of Medicine

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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

Inclusion Criteria:

  1. Be willing to provide a signed written informed consent for the trial and consent for biopsies before and during administration of EOS884448
  2. Be more than18 years of age on day of signing informed consent.
  3. Have histologically or cytologically confirmed advanced or metastatic cancer for whom no standard treatment is further available
  4. Have evaluable disease, per RECIST v1.1 for solid tumor escalation or other criteria if indicated
  5. Have an ECOG performance status of Grade 0 to 1.
  6. Have adequate organ function.
  7. Agree to use adequate contraception during the treatment if required.

Exclusion Criteria:

  1. Has received any anti-cancer therapy, unless at least 4 weeks (or 5 half-lives, whichever is shorter) since the last dose.
  2. Has undergone major surgery within 5 weeks before initiating treatment.
  3. Has received prior radiotherapy within 2 weeks of start of IP.
  4. Has toxicity (except for alopecia) related to prior anti-cancer therapy, unless the toxicity is resolved, returned to baseline or Grade 1, or deemed irreversible.
  5. Has known CNS metastases.
  6. Has any condition requiring concurrent use of systemic immunosuppressants or corticosteroids.
  7. Has uncontrolled or significant cardiovascular disease.
  8. Has received vaccine containing live virus within 4 weeks.
  9. Has known active or chronic viral hepatitis.
  10. Has any known or underlying medical, psychiatric condition, and/or social situations that, in the opinion of the investigator, would limit compliance with study requirements.

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): NCT04335253


Contacts
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Contact: Olivier De Henau, MD +32 71 919 934 clinical_info@iteostherapeutics.com

Locations
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Belgium
GZA Ziekenhuizen campus Sint-Augustinus Recruiting
Antwerp, Belgium, 2610
Contact: Tom Van den Mooter, MD         
Institut Jules Bordet Recruiting
Brussels, Belgium, 1000
Contact: Christiane Jungels, MD         
Cliniques universitaires St Luc-UCL Recruiting
Brussels, Belgium
Contact: Jean-Pascal Machiels, MD/PhD         
Universitair Ziekenhuis Gent Recruiting
Gent, Belgium, 9000
Contact: Sylvie Rottey, MD/PhD         
Sponsors and Collaborators
iTeos Therapeutics
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Responsible Party: iTeos Therapeutics
ClinicalTrials.gov Identifier: NCT04335253    
Other Study ID Numbers: IO-002
First Posted: April 6, 2020    Key Record Dates
Last Update Posted: April 6, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms