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

Phase I/IIa First-In-Human Study of EOS884448 in Participants With Advanced Cancers.

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.

Study Overview

• Status: Completed
• Conditions: Advanced Cancer
• Intervention / Treatment: Drug: EOS884448

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium, 2610
    • GZA Ziekenhuizen campus Sint-Augustinus
  • Brussels, Belgium, 1000
    • Institut Jules Bordet
  • Brussels, Belgium
    • Cliniques universitaires St Luc-UCL
  • Gent, Belgium, 9000
    • Universitair Ziekenhuis Gent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multiple Ascending Dose; Dose escalation according to cohort allocation	Drug: EOS884448; Multiple Ascending Dose; Other Names: EOS-448

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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
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.	From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 48 weeks)
Percentage of participants with anti-drug antibodies to EOS884448	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)

Collaborators and Investigators

• Sponsor: iTeos Belgium SA

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2020
• Primary Completion (Actual): April 7, 2022
• Study Completion (Actual): April 7, 2022

Study Registration Dates

• First Submitted: April 1, 2020
• First Submitted That Met QC Criteria: April 2, 2020
• First Posted (Actual): April 6, 2020

Study Record Updates

• Last Update Posted (Actual): June 16, 2022
• Last Update Submitted That Met QC Criteria: June 15, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: IO-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No