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

• Status: Active, not recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: iTeos Belgium SA; iTeos Therapeutics

Criteria

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.