Clinical trial NCT04335253: First-In-Human Study of EOS884448 in Participants with Advanced Cancers.
Official title: Phase I/IIa First-In-Human Study of EOS884448 in Participants with Advanced Cancers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Cancer
Lead sponsor: iTeos Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: iTeos Belgium SA
First posted: 2020-04-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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 consist in a dose-escalation phase to determine the MTD, the RP2D, and the safety of EOS884448 in participants with advanced cancers.

Eligibility 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.

Primary outcomes:
measure: Percentage of participants with Adverse Events
timeFrame: From first dose date to 90 days after the last dose (up to 48 weeks)
measure: Percentage of participants who experience a Dose Limiting Toxicity
timeFrame: From first study treatment administration through Day 28
measure: Define the recommended Phase 2 dose (RP2D) of EOS884448 in participants with advanced tumors.
timeFrame: up to 48 weeks
Secondary outcomes:
measure: Mean and median Area under the curve (AUC) of EOS884448 at each dose level
timeFrame: up to 48 weeks
measure: Mean and median Maximum concentration (Cmax) of EOS884448 at each dose level
timeFrame: up to 48 weeks
measure: 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.
timeFrame: From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 48 weeks)
measure: Percentage of participants with anti-drug antibodies to EOS884448
timeFrame: 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)
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: GZA Ziekenhuizen campus Sint-Augustinus
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Brussels
country: Belgium
facility: Cliniques universitaires St Luc-UCL
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
Study officials:
References: