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

NCT04335253 | Completed Phase 1

• 1 other identifier: IO-002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

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.

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (3)

• 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 (4)

• 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)

Study Arms (1)

Multiple Ascending Dose

EXPERIMENTAL

Dose escalation according to cohort allocation

Drug: EOS884448

Interventions

EOS884448 DRUG

Multiple Ascending Dose

Also known as: EOS-448

Multiple Ascending Dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• iTeos Therapeutics: lead
• iTeos Belgium SA: collaborator

Study Sites (4)

GZA Ziekenhuizen campus Sint-Augustinus

Antwerp, 2610, Belgium

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Cliniques universitaires St Luc-UCL

Brussels, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 6, 2020
• Study Start: February 18, 2020
• Primary Completion: April 7, 2022
• Study Completion: April 7, 2022
• Last Updated: September 19, 2024

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (4)