First-In-Human Study of EOS884448 in Participants With Advanced Cancers.
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|ClinicalTrials.gov Identifier: NCT04335253|
Recruitment Status : Completed
First Posted : April 6, 2020
Last Update Posted : June 16, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Advanced Cancer||Drug: EOS884448||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/IIa First-In-Human Study of EOS884448 in Participants With Advanced Cancers.|
|Actual Study Start Date :||February 18, 2020|
|Actual Primary Completion Date :||April 7, 2022|
|Actual Study Completion Date :||April 7, 2022|
Experimental: Multiple Ascending Dose
Dose escalation according to cohort allocation
Multiple Ascending Dose
Other Name: EOS-448
- 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 ]
- 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) ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04335253
|GZA Ziekenhuizen campus Sint-Augustinus|
|Antwerp, Belgium, 2610|
|Institut Jules Bordet|
|Brussels, Belgium, 1000|
|Cliniques universitaires St Luc-UCL|
|Universitair Ziekenhuis Gent|
|Gent, Belgium, 9000|
|Responsible Party:||iTeos Belgium SA|
|Other Study ID Numbers:||
|First Posted:||April 6, 2020 Key Record Dates|
|Last Update Posted:||June 16, 2022|
|Last Verified:||September 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|