AB122 Platform Study

Actively Recruiting

Phase 1

Age: 18Years +

All Genders

NCT04999761

Led by Taiho Pharmaceutical Co., Ltd. · Updated on 2024-09-25

917

Participants Needed

Research Sites

256 weeks

Total Duration

AI-Summary

What this Trial Is About

This is a phase 1, non-randomized open-label, multicenter platform study designed to evaluate the tolerability and safety of AB122 in patients with malignancies specified in each cohort.

CONDITIONS

Official Title

AB122 Platform Study

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Male or female aged 18 years or older at consent
Willing and able to comply with scheduled visits and study procedures (except Cohort E-2)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 before treatment
Adequate organ function: AST and ALT levels 3 times upper limit of normal (ULN), or 5 times ULN with liver metastases
Total bilirubin 1.5 times ULN
Absolute neutrophil count (ANC) 1500/mm3 excluding recent G-CSF use
Platelet count 100,000/mm3 excluding recent transfusion
Hemoglobin 9.0 g/dL excluding recent transfusion
Life expectancy of at least 90 days
Cohort-specific criteria including confirmed diagnosis, prior treatments, and disease progression as detailed for each cohort

You will not qualify if you...

History or current cardiac arrhythmia or conduction abnormalities that increase risk of QT prolongation
Major surgery within 4 weeks before study treatment
Radiotherapy within 4 weeks (extended field) or 2 weeks (limited field)
Any anticancer therapy within 2 weeks before treatment
Investigational agent use within 5 half-lives or 4 weeks before treatment
Unresolved toxicity of grade 2 or higher from prior therapies (except anemia, neuropathy, alopecia, skin pigmentation)
Active serious illnesses including acute infections, interstitial lung disease requiring steroids, recent myocardial infarction or severe heart failure, severe kidney disease, positive HIV, hepatitis B or C (unless RNA negative)
Other severe medical or psychiatric conditions affecting study participation
Previous or concurrent cancer distinct from study cancer (with specific exceptions)
Women of childbearing potential and male partners not agreeing to effective birth control
Prior treatment with immune checkpoint inhibitors except certain cohorts
Live vaccine within 30 days before treatment (inactivated flu vaccine allowed)
Immunodeficiency or recent immunosuppressive therapy
Active autoimmune disease requiring systemic treatment in past 2 years
Known active central nervous system metastases unless stable and off steroids
Conditions or therapies that may interfere with participation or study results as judged by investigator

AI-Screening