What is AB122 studying for advanced solid tumors?

AB122 is being studied to evaluate its safety and tolerability in patients with various advanced or metastatic solid tumors. Researchers aim to understand how AB122 works alone or combined with other cancer drugs in different types of cancers. This study is sponsored by Taiho Pharmaceutical Co., Ltd.

Who may be eligible for this advanced solid tumor clinical trial?

Adults 18 years or older with advanced or metastatic solid tumors may be eligible. Participants must have good organ function and an ECOG performance status of 0 or 1. Both men and women can join. Please review eligibility criteria for more details.

Is there any cost to participate in this advanced solid tumor clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses to and from the study site may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 1

Age: 18Years +

All Genders

ID04999761

Platform Study of AB122 Based Treatments in Patients with Advanced Solid Tumors

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

917

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating AB122 in a phase 1, non-randomized open-label study across multiple centers to assess its safety and tolerability in patients with various advanced or metastatic solid tumors. The study includes several cohorts with malignancies such as pancreatic ductal adenocarcinoma, colorectal cancer, non-small cell lung cancer, gastric cancer, alveolar soft part sarcoma, esophageal cancer, head and neck cancer, and biliary tract cancer. This platform study aims to gather safety data and initial response information for AB122 alone and in combination with other treatments. AB122 is administered by infusion at doses of either 240 mg or 360 mg every two or three weeks, respectively, depending on the cohort. Some cohorts receive AB122 alone, while others receive it combined with drugs like TAS-116, TAS-120, TAS-115, TAS-102, Ramucirumab, Bevacizumab, Fluorouracil, Cisplatin, Carboplatin, nab-Paclitaxel, Gemcitabine, or AB154. These treatments are given on various schedules including oral administration, continuous infusion, or infusions at specified intervals, tailored to the cancer type and treatment combination. Participants will be monitored closely through scheduled visits involving assessments of adverse events, dose-limiting toxicities, and objective tumor responses over up to 11 months of treatment. Safety evaluations include laboratory tests, imaging, and physical exams, with special attention to organ function and disease progression. The primary outcomes include measuring the percentage of participants experiencing toxicities and tumor response rates, helping researchers understand the safety profile and potential activity of AB122 and its combinations in these cancer patients.

CONDITIONS

Brief 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 the time of informed consent
Willing and able to comply with scheduled visits and study procedures (except for Cohort E-2)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 before study treatment
Adequate organ function including specific limits for AST, ALT, total bilirubin, ANC, platelet count, and hemoglobin
Life expectancy of at least 90 days
Specific cancer diagnoses and treatment histories as defined for each cohort, such as advanced or metastatic solid tumors, pancreatic ductal adenocarcinoma, colorectal cancer, non-small cell lung cancer, gastric cancer, alveolar soft part sarcoma, esophageal cancer, head and neck cancer, and biliary tract cancer
Japanese male and female for Cohort A-1 and A-2
Various prior treatment and disease progression requirements per cohort as detailed in the eligibility criteria

You will not qualify if you...

History or current evidence of cardiac arrhythmia or conduction abnormalities increasing risk of QTc prolongation or arrhythmias
Major surgery within 4 weeks prior to study treatment start
Extended-field radiotherapy within 4 weeks or limited-field radiotherapy within 2 weeks prior to study treatment
Any anticancer therapy within 2 weeks prior to study treatment
Use of investigational agents within 5 half-lives or 4 weeks prior to study treatment
Unresolved toxicities of grade 2 or higher from prior therapies (excluding certain conditions)
Acute systemic infection or active interstitial lung disease requiring steroid treatment
Recent serious cardiac events such as myocardial infarction or severe heart failure within 6 months
Severe chronic kidney disease
Known positivity for HIV, hepatitis B surface antigen, or hepatitis C antibody unless RNA negative
Other severe acute or chronic medical or psychiatric conditions that increase risk or interfere with study participation
Previous or concurrent distinct cancers except certain treated types or those treated over 5 years prior
Women of childbearing potential or men not agreeing to effective birth control during and after study as specified
Prior treatment with certain immune checkpoint inhibitors except for specified cohorts
Receipt of live vaccines within 30 days prior to study treatment
Diagnosis of immunodeficiency or recent systemic immunosuppressive therapy
Active autoimmune disease requiring systemic treatment in past 2 years
Known active central nervous system metastases or carcinomatous meningitis unless stable and off steroids
Any condition or therapy that may confound study results or interfere with participation in the investigator’s opinion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 11 months

Participants receive AB122-based drug treatments with different regimens depending on their assigned cohort. Treatments include AB122 infusions every 2 or 3 weeks, and combinations with oral drugs taken daily or in cycles, as well as other infusions. Treatment continues based on the assigned dosing schedules and until disease progression or discontinuation.

Regular visits for drug infusions and oral medication assessments, with dosing every 2 or 3 weeks and oral medications taken daily or in cycles