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CompletedNCT04335253Updated Sep 19, 2024

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

A Phase 1 interventional study of EOS884448 in Advanced Cancer, sponsored by iTeos Therapeutics. Completed at 4 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by iTeos Therapeutics · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Advanced Cancer

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 40 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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Lead sponsor

iTeos Therapeutics is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Multiple Ascending Dose

    Dose escalation according to cohort allocation

    Drug: EOS884448

Interventions

  • DrugEOS884448

    Multiple Ascending Dose

    Also known as: EOS-448

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What researchers measure

Primary outcomes

  1. Percentage of participants with Adverse Events

    Time frame: From first dose date to 90 days after the last dose (up to 48 weeks)

  2. Percentage of participants who experience a Dose Limiting Toxicity

    Time frame: From first study treatment administration through Day 28

  3. Define the recommended Phase 2 dose (RP2D) of EOS884448 in participants with advanced tumors.

    Time frame: up to 48 weeks

Secondary outcomes

  1. Mean and median Area under the curve (AUC) of EOS884448 at each dose level

    Time frame: up to 48 weeks

  2. Mean and median Maximum concentration (Cmax) of EOS884448 at each dose level

    Time frame: up to 48 weeks

  3. 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.

    Time frame: From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 48 weeks)

  4. Percentage of participants with anti-drug antibodies to EOS884448

    Time frame: 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)

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Study locations

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

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04335253
Lead sponsor
iTeos Therapeutics
Collaborators
iTeos Belgium SA
Responsible party
Sponsor
First posted
Apr 6, 2020
Start date
Feb 18, 2020
Primary completion
Apr 7, 2022
Completion
Apr 7, 2022
Last update
Sep 19, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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