First-In-Human Study of EOS884448 in Participants with Ad... | NCT04335253

Studies
First-In-Human Study of EOS884448 in Participants with Advanced Cancers.

NCT04335253

Sponsor

iTeos Therapeutics

Status

Completed

Last Update Posted

Sep 19, 2024Actual

Enrollment

40Actual

Phase

Phase 1

Conditions

Advanced Cancer

Interventions

EOS884448

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 18, 2020Actual

Primary Completion Date

Apr 7, 2022Actual

Completion Date

Apr 7, 2022Actual

First Submitted Date

Apr 1, 2020

First Submission Date that Met QC Criteria

Apr 2, 2020

First Posted Date

Apr 6, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 6, 2024

Last Update Posted Date

Sep 19, 2024Actual

Name	Class
iTeos Belgium SA	INDUSTRY

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Label	Type	Description	Intervention Names
Multiple Ascending Dose	Experimental	Dose escalation according to cohort allocation	Drug: EOS884448

Name	Type	Description	Arm Group Labels	Other Names
EOS884448	Drug	Multiple Ascending Dose	Multiple Ascending Dose	EOS-448

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Mean and median Area under the curve (AUC) of EOS884448 at each dose level		up to 48 weeks
Mean and median Maximum concentration (Cmax) of EOS884448 at each dose level		up to 48 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
GZA Ziekenhuizen campus Sint-Augustinus		Antwerp		2610	Belgium
Institut Jules Bordet