AB122 Platform study
- Conditions
- Advanced or metastatic solid tumor
- Registration Number
- JPRN-jRCT2011210020
- Lead Sponsor
- asermoaddeli Ali
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 715
General Inclusion Criteria
(1) Is male or female aged >= 18 years at the time of informed consent; Willing and able to comply with scheduled visits and study procedures (except for Cohort E-2);
(2) Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 before administration of study treatment;
(3) Has adequate organ function as defined by the following criteria:
a.AST and ALT =< 3 x ULN; or if a patient with documented liver metastases, AST and ALT =< 5 x ULN
b.T-Bil of =< 1.5 x ULN
c.ANC >= 1500 /mm3 (ie, >= 1.5 x 109 /L by International System of Units [SI]) (excluding measurements obtained within 7 days after administration of granulocyte colony-stimulating factor [G-CSF])
d.Platelet count >= 100000 /mm3 (SI: >= 100 x 109 /L) (excluding measurements obtained within 7 days after a transfusion of platelets)
e.Hemoglobin value of >= 9.0 g/dL excluding measurements within 4 weeks after a transfusion of packed red blood cells (RBCs) or whole blood
(4) Has a life expectancy of at least 90 days;
Cohort A-1 and A-2
1. Japanese male and female;
2. Has a histologically or cytologically confirmed diagnosis of solid tumor;
3. Has disease progression after standard treatment for advanced or metastatic disease, are intolerant to the standard treatment;
Cohort B-1
1. Has a histologically or cytologically confirmed diagnosis of PDAC;
2. Has disease progression after or intolerant to one regimen of prior systemic chemotherapy for advanced or metastatic disease
Cohort B-2
1. Has a histologically or cytologically confirmed diagnosis of CRC.
2. Has been received one regimen of standard chemotherapy for advanced or metastatic disease, and was refractory or intolerant to the chemotherapy
Cohort B-3
1. Has a histologically or cytologically confirmed non-squamous NSCLC;
2. Has been received one or two regimen of standard chemotherapy for advanced or metastatic disease, and was refractory or intolerant to the standard treatment
3. Has been most recently received regimen including an ICI (anti PD-1 antibodies, anti PD-L1 antibodies or anti CTLA-4 antibodies) and platinum-based chemotherapy in combination or in sequence (i.e., platinum-based chemotherapy followed by checkpoint inhibitor therapy), and all of the following criteria must be met;
- Received at least 2 doses at the most recent ICI therapy
- Radiographic complete response or partial response based on investigator assessment with ICI therapy
Cohort C-1
1. Has unresectable advanced or recurrent gastric cancer or gastroesophageal junction cancer as pathologically confirmed adenocarcinoma
Gastroesophageal junction cancer is defined as a tumor with an epicenter that is located within 2 cm proximal to and distal from the esophagogastric junction (the boundary of esophageal and gastric muscularis).
2. Has received 2-4 standard regimens listed below and has demonstrated disease progression according to imaging test during the most recent treatment or within 12 weeks after the final dose (The patient is eligible if the treatment is discontinued owing to SAEs, allergic reactions, or neurotoxicities.):
- fluoropyrimidines and platinum
- taxane or irinotecan
- ramucirumab
Cohort C-2
1. Has histologically confirmed unresectable adenocarcinoma of the colon or rectum (all other histological types are excluded);
2. RAS status must have been previously determined (mutant or wild-type) based on local assessment of tumor biopsy.
Wild type is defined as v-Ki
(1) 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.;
(2) Treatment with any of the following within the specified time frame prior to the day on which study treatment is scheduled to be started:
a. 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);
b. Extended-field radiotherapy within 4 weeks or limited-field radiotherapy within 2 weeks;
c. Any anticancer therapy within 2 weeks;
d. Any investigational agent received within 5 half-lives of the drug or 4 weeks, whichever shorter;
(3) Unresolved toxicity of >= Grade 2 attributed to any prior therapies (excluding anemia, peripheral sensory neuropathy, alopecia and skin pigmentation);
(4) A serious illness or medical condition(s) including, but not limited to, the following specific medical conditions:
a. Known acute systemic infection;
b. 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;
c. 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;
d. Known severe chronic kidney disease;
e. 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;
f. 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;
(5) 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;
(6) WOCBP or male patients who do not agree to effective birth control during the following period
- WOCBP patients: during the clinical study and until 100 days after the last dose of AB122, 180 days after TAS-116, TAS-102, TAS-120 or TAS-115, whichever is later;
- Male patients with WOCBP partners: during the clinical study and until 100 days after the last dose of AB122, 180 days after TAS-116, TAS-102, TAS-120 or TAS-115, whichever is later;
(7) Prior treatment with an anti-PD-L1 anti-PD-1, anti-CTLA-4, or other ICI or agonist as monotherapy or in combination (except for cohortB-3, C-1, D-1 tolerability part and E-1).
(8) Has received a live vaccine within 30 days prior to study treatment including, but not limited to the following examples: measles, mumps, rubella, var
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method