Advanced CancerPhase 1NCT04335253
First-In-Human Study of EOS884448 in Participants with Advanced Cancers.
A Phase 1 study testing EOS884448 in people with Advanced Cancer, run by iTeos Therapeutics at 4 sites in Belgium.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- EOS884448
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesBelgium
- Study dates
- 18 Feb 2020to 7 Apr 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country.
Belgium4 sites
GZA Ziekenhuizen campus Sint-Augustinus
Antwerp, 2610
Institut Jules Bordet
Brussels, 1000
Cliniques universitaires St Luc-UCL
Brussels
Universitair Ziekenhuis Gent
Ghent, 9000
About this study
Official title: 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.
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.
- Conditions
- Advanced Cancer
- Being tested
- EOS884448
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EOS884448Drug
Also called EOS-448
Multiple Ascending Dose
| Study group | Role | What they receive |
|---|---|---|
| Multiple Ascending Dose | Experimental | Dose escalation according to cohort allocation Receives: Drug: EOS884448 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with Adverse Events
Measured: From first dose date to 90 days after the last dose (up to 48 weeks)
Percentage of participants who experience a Dose Limiting Toxicity
Measured: From first study treatment administration through Day 28
Define the recommended Phase 2 dose (RP2D) of EOS884448 in participants with advanced tumors.
Measured: up to 48 weeks
Secondary outcomes (4)
Mean and median Area under the curve (AUC) of EOS884448 at each dose level
Measured: up to 48 weeks
Mean and median Maximum concentration (Cmax) of EOS884448 at each dose level
Measured: 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.
Measured: 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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start18 Feb 2020
- Primary completion7 Apr 2022
- Study completion7 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- iTeos Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- iTeos Belgium SA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04335253
- Sponsor's protocol ID
- IO-002
- Status last verified
- Sep 2021
- First submitted
- 1 Apr 2020
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/IIa First-In-Human Study of EOS884448 in Participants with Advanced Cancers.
- ClinicalTrials.gov ID
- NCT04335253
- Acronym / sponsor ID
- IO-002
- Conditions
- Advanced Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- iTeos TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- iTeos Belgium SA
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- 7 Apr 2022 (actual)
- Study completion
- 7 Apr 2022 (actual)
- First posted
- 6 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple Ascending Dose | Experimental | Drug: EOS884448Dose escalation according to cohort allocation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EOS884448Also: EOS-448Multiple Ascending Dose | Drug | Multiple Ascending Dose |
Primary outcome
Percentage of participants with Adverse Events
Time frame: From first dose date to 90 days after the last dose (up to 48 weeks)
Percentage of participants who experience a Dose Limiting Toxicity
Time frame: From first study treatment administration through Day 28
Define the recommended Phase 2 dose (RP2D) of EOS884448 in participants with advanced tumors.
Time frame: up to 48 weeks
4 secondary outcomes
Mean and median Area under the curve (AUC) of EOS884448 at each dose level
Time frame: up to 48 weeks
Mean and median Maximum concentration (Cmax) of EOS884448 at each dose level
Time frame: 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.
Time frame: 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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EOS884448 in people with Advanced Cancer, run by iTeos Therapeutics at 4 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with Adverse Events (time frame: From first dose date to 90 days after the last dose (up to 48 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.