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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-18

Study Completion Date

2022-04-07

Brief Summary

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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.

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Detailed Description

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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

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Advanced Cancer

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Multiple Ascending Dose

Dose escalation according to cohort allocation

Group Type EXPERIMENTAL

EOS884448

Intervention Type DRUG

Multiple Ascending Dose

Interventions

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EOS884448

Multiple Ascending Dose

Intervention Type DRUG

Other Intervention Names

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EOS-448

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No