Status:
COMPLETED
First-In-Human Study of EOS884448 in Participants with Advanced Cancers.
Lead Sponsor:
iTeos Therapeutics
Collaborating Sponsors:
iTeos Belgium SA
Conditions:
Advanced Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
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 stud...
Eligibility Criteria
Inclusion
- Be willing to provide a signed written informed consent for the trial and consent for biopsies before and during administration of EOS884448
- Be more than18 years of age on day of signing informed consent.
- Have histologically or cytologically confirmed advanced or metastatic cancer for whom no standard treatment is further available
- Have evaluable disease, per RECIST v1.1 for solid tumor escalation or other criteria if indicated
- Have an ECOG performance status of Grade 0 to 1.
- Have adequate organ function.
- Agree to use adequate contraception during the treatment if required.
Exclusion
- Has received any anti-cancer therapy, unless at least 4 weeks (or 5 half-lives, whichever is shorter) since the last dose.
- Has undergone major surgery within 5 weeks before initiating treatment.
- Has received prior radiotherapy within 2 weeks of start of IP.
- 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.
- Has known CNS metastases.
- Has any condition requiring concurrent use of systemic immunosuppressants or corticosteroids.
- Has uncontrolled or significant cardiovascular disease.
- Has received vaccine containing live virus within 4 weeks.
- Has known active or chronic viral hepatitis.
- 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.
Key Trial Info
Start Date :
February 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 7 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04335253
Start Date
February 18 2020
End Date
April 7 2022
Last Update
September 19 2024
Active Locations (4)
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1
GZA Ziekenhuizen campus Sint-Augustinus
Antwerp, Belgium, 2610
2
Institut Jules Bordet
Brussels, Belgium, 1000
3
Cliniques universitaires St Luc-UCL
Brussels, Belgium
4
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000