AB122 Platform Study

• Status: Recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Taiho Pharmaceutical Co., Ltd.

Criteria

Inclusion Criteria:

• Is male or female aged ≥ 20 years at the time of informed consent; Willing and able to comply with scheduled visits and study procedures;

• Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 before administration of study treatment;

• Has adequate organ function as defined by the following criteria:

1. AST and ALT ≤ 3 × ULN; or if a patient with documented liver metastases, AST and ALT ≤ 5 × ULN

2. T-Bil of ≤ 1.5 × ULN

3. ANC ≥ 1500 /mm3 (ie, ≥ 1.5 × 109 /L by International System of Units [SI]) (excluding measurements obtained within 7 days after administration of granulocyte colony-stimulating factor [G-CSF])

4. Platelet count ≥ 100000 /mm3 (SI: ≥ 100 × 109 /L) (excluding measurements obtained within 7 days after a transfusion of platelets)

5. Hemoglobin value of ≥ 9.0 g/dL excluding measurements within 4 weeks after a transfusion of packed red blood cells (RBCs) or whole blood

• Has a life expectancy of at least 90 days; Cohort A-1 and A-2

• Japanese male and female;

• Has a histologically or cytologically confirmed diagnosis of solid tumor;

• Has disease progression after standard treatment for advanced or metastatic disease, are intolerant to the standard treatment; Cohort B-1

• Has a histologically or cytologically confirmed diagnosis of PDAC;

• Has disease progression after or intolerant to one prior systemic chemotherapy for advanced or metastatic disease Cohort B-2

• Has a histologically or cytologically confirmed diagnosis of CRC, which documented evidence of any activating mutation in the BRAF by a local laboratory test or an MHLW approved test;

• Has been received one or two regimen of standard chemotherapy for advanced or metastatic disease, and was refractory or intolerant to those chemotherapies

Exclusion Criteria:

• History or current evidence of cardiac arrhythmia and/or conduction abnormality: Any factor that can increase the risk of corrected QT interval (QTc) prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, etc.;

• Treatment with any of the following within the specified time frame prior to the day on which study treatment is scheduled to be started:

1. Major surgery within 4 weeks (the surgical incision should be fully healed prior to the day on which study treatment is scheduled to be started);

2. Extended-field radiotherapy within 4 weeks or limited-field radiotherapy within 2 weeks;

3. Any anticancer therapy within 2 weeks;

4. Any investigational agent received within 5 half-lives of the drug or 4 weeks, whichever shorter;

• Unresolved toxicity of ≥ Grade 2 attributed to any prior therapies (excluding anemia, peripheral sensory neuropathy, alopecia and skin pigmentation);

• A serious illness or medical condition(s) including, but not limited to, the following specific medical conditions:

1. Known acute systemic infection;

2. Known medical history of interstitial lung disease/ drug-induced interstitial lung disease/ radiation pneumonitis which required steroid treatment/ any evidence of clinically active interstitial lung disease;

3. Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV, Appendix A) within the previous 6 months; if > 6 months, cardiac function must be within normal limits and the patient must be free of cardiac-related symptoms;

4. Known severe chronic kidney disease;

5. Known positivity of human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody in baseline virus test. In addition, the patient who is known negative in HCV ribonucleic acid (RNA) is eligible, even if positive for HCV antibody;

6. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study treatment, or may interfere with the interpretation of study results, and in the judgment of the investigator or sub-investigator would make the patient inappropriate for entry into this study;

• Previous or concurrent cancer that is distinct in primary disease or histology from the cancer being evaluated in this study, except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (stage Ta, Tis and T1), cancers corresponding to intraepithelial or intramucosal neoplasia, or any cancer curatively treated > 5 years prior to the day on which study treatment is scheduled to be started;

• WOCBP or male patients who do not agree to effective birth control during the following period

1. WOCBP patients: during the clinical study and until 100 days after the last dose of AB122, 180 days after TAS-116, whichever is later;

2. Male patients with WOCBP partners: during the clinical study and until 100 days after the last dose of AB122, 180 days after TAS-116, whichever is later;

• Prior treatment with an anti-PD-L1 anti-PD-1, anti-CTLA-4, or other immune checkpoint inhibitor or agonist as monotherapy or in combination.

• Has received a live vaccine including, but not limited to the following examples:

measles, mumps, rubella, varicella-zoster, yellow fever, and BCG. The inoculation with inactivated vaccines for seasonal influenza is allowed.

• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to enrollment.

• Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.

• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable, ie, without evidence of progression for at least 28 days by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to enrollment.

• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating investigator. (eg, paresis of intestine, intestinal obstruction, unable to receive 5% dextrose in water [DW] in patients with diabetes mellitus, respiratory failure, renal failure, hepatic failure, cerebrovascular disorder, gastrointestinal ulcers that require transfusion or are hemorrhagic, and wounds/bone fractures associated with neovascularization during the healing process, accumulation of pleural within 2 weeks prior to enrollment, ascitic, or pericardial fluid requiring drainage).