A Phase I Trial to Investigate the Tolerability, Safety, Pharmacokinetics, Biological and Clinical Activity of Avelumab (MSB0010718C) in Japanese Subjects With Metastatic or Locally Advanced Solid Tumors, With Expansion Part in Asian Subjects With Gastric Cancer
- Conditions
- Solid Tumors
- Registration Number
- JPRN-jRCT2080222945
- Lead Sponsor
- Merck Biopharma Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 57
Signed written informed consent
Male or female subjects aged greater than or equal to 20 years.
For dose escalation part
Histologically or cytologically proven metastatic or locally advanced solid tumors, for which no standard therapy exists or standard therapy has failed
For expansion part
Availability of fresh and archive tumor in formalin fixedparaffin embedded tissue
With histologically or cytologically confirmed recurrent or refractory unresectable Stage IV gastric or gastro-esophageal junctional adenocarcinoma (according to American Joint Committee on Cancer/Union Internationale Contre le Cancer [UICC] 7th edition) and whose disease progressed after one or two prior chemotherapy regimen(s) involving both fluoropyrimidines and platinum.
Presence of at least 1 measurable lesion according to RECIST version 1.1
Subjects should not have severe peritoneal metastases. The following criteria were applied:
-No clinical ileus or subileus
-No moderate-to-severe ascites (subjects with ascites restricted to the perihepatic space or pelvic cavity)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at the trial entry and an estimated life expectancy of at least 3 months
Adequate hematological, hepatic and renal function as defined in the protocol
All subjects must agree to use effective means of contraception with their partner from entry into the trial through 6 months after the last dose of avelumab
-Concurrent treatment with a non-permitted drug
-Prior therapy with any antibody/drug targeting T cell co-regulatory proteins (immune checkpoints)
-Concurrent anticancer treatment or concurrent systemic therapy with steroids or other immunosuppressive agents, or use of any investigational drug within 30 days before the start of trial treatment. Short-term administration of steroids (that is, for allergic reactions or the management of immune-related adverse events [irAE]) is allowed
-Previous malignant disease within the last 5 years with the exception of adequately treated non-melanoma skin cancer, in situ cancer, or other cancer
-Non-oncology vaccine therapies for prevention of infection disease (e.g. seasonal flu vaccine, human papilloma virus vaccine) within 4 weeks of study drug administration. Vaccination while on study is also prohibited except for administration of the inactivated influenza vaccine.
-Pregnancy or lactation period
-Known alcohol or drug abuse
-Clinically significant (that is, active) cardiovascular disease
-All other significant diseases (for example, inflammatory bowel disease), which, in the opinion of the investigator, might impair the subject's tolerance of trial treatment
-Any psychiatric condition that would prohibit the understanding or rendering of informed consent
-Legal incapacity or limited legal capacity
-Other protocol defined exclusion criteria could apply
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method