Phase 1 N=18 Treatment

ONO-4538 Phase I Study in Patients With Solid Tumor

Advanced Solid Tumors · Recurrent Solid Tumors

Bottom Line

View on ClinicalTrials.gov: NCT02261285 ↗

Enrolled (actual)

Serious AEs

11.1%

Results posted

Apr 2024

Primary outcome: Primary: PK Outcome: Cmax of ONO-4538 — 26.0; 64.3; 242.0 µg/mL

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: ONO-4538 (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Ono Pharmaceutical Co., Ltd.
Primary completion: Dec 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY PK Outcome: Cmax of ONO-4538	26.0; 64.3; 242.0	—
PRIMARY PK Outcome: Tmax of ONO-4538	3.02; 3.00; 2.99	—
PRIMARY AUC21day	5110; 12200; 38700	—
PRIMARY AUCinf	9180; 22800; 68100	—
PRIMARY T1/2	18.3; 19.1; 15.0	—
SECONDARY Safety Outcome: The Number of Subjects With Overall Adverse Events	5; 4; 5	—
SECONDARY Safety Outcome: The Number of Deaths	1; 0; 1	—

Summary

The objective of the study is to investigate the pharmacokinetics of ONO-4538 administered to Korean patients with advanced or recurrent solid tumors who are refractory or intolerant to standard therapy or for whom no appropriate treatment is available.

Eligibility Criteria

Inclusion Criteria

Male or female ≥ 20 years of age
Histologically or cytologically confirmed solid tumor
Patients with advanced or recurrent solid tumors who are refractory or intolerant to standard therapy or for whom no appropriate treatment is available
ECOG Performance Status is 0 to 1

Exclusion Criteria

Current or prior severe hypersensitivity to another antibody product
Multiple primary cancers

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02261285). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.