JPRN-jRCT2080224822
Completed
Phase 1
A Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 404, a Programmed Death-1 (PD-1) Antibody, in Patients With Advanced Solid Tumors
ConditionsAdvanced Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Advanced Solid Tumors
- Sponsor
- Amgen K.K.
- Enrollment
- 275
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Subject has provided informed consent prior to initiation of any study specific activities/procedures.
- •2\. Age greater than or equal to 18 years old at the time of signing informed consent.
- •3\. Life expectancy of greater than 3 months, in the opinion of the investigator
- •4\. Subject must have histologically or cytologically confirmed metastatic or locally advanced solid tumors not amenable to curative treatment with surgery or radiation.
- •5\. Cohort 7: participant must have one of the following tumor types: melanoma, small cell lung cancer, NSCLC (PD\-L1 positive), head and neck squamous cell cancer (PD\-L1 positive),urothelial (PD\-L1 positive), gastric or GEJ adenocarcinoma (PD\-L1 positive), esophageal (squamous, PD\-L1 positive), cervical (PD\-L1 positive), hepatocellular carcinoma, merkel cell carcinoma, squamous cell carcinoma of the skin, renal cell carcinoma (clear cell) subtypes of sarcoma (undifferentiated pleiomorphic / malignant fibrous histiocytoma, poorly differentiated and/or dedifferentiated liposarcoma, alveolar soft tissue sarcoma, angiosarcoma), thymic carcinoma, nasopharyngeal carcinoma (EBV positive), mesothelioma
- •6\. Cohort 8: participant must be MSI\-H or MMR\-deficient
- •7\. Cohort 9: participant must have NSCLC, PD\-L1 positive, TPS \>\= 50%; not have EGFR or ALK orROS1 genomic tumor aberrations and may not have received prior systemic treatment for the advanced disease (prior neoadjuvant, adjuvant, or concurrent chemoradiation is allowed).
- •8\. At least 1 measurable as defined by modified RECIST 1\.1 which has not undergone biopsy within 3 months of the screening scan. This lesion cannot be biopsied at any time during the study. Note: if there is only one lesion available for biopsy and radiographic assessment, it may be permitted to be biopsied after discussion with sponsor.
- •9\. Subjects with treated brain metastases are eligible provided they meet the following criteria: Definitive therapy was completed at least 2 weeks prior to enrollment. No evidence of radiographic CNS progression or CNS disease following definitive therapy and by the time of study screening. Patients manifesting progression in lesions previously treated with stereotactic radiosurgery may still be eligible if pseudoprogression can be demonstrated by appropriate means and after discussion with the medical monitor.
- •10\. Any CNS disease is asymptomatic, any neurologic symptoms due to CNS disease have returned to baseline or are deemed irreversible, the patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the patient is off or on stable doses of anti\-epileptic drugs for malignant CNS disease.
Exclusion Criteria
- •1\. Disease Related. Primary brain tumor, untreated or symptomatic brain metastases and leptomeningeal disease (exception: benign asymptomatic tumors are permitted).
- •2\. Other Medical Conditions. History of other malignancy within the past 2 years, with the following exception\[s]: Malignancy treated with curative intent and with no known active disease present for greater than or equal to 2 years before enrollment and felt to be at low risk for recurrence by the treating physician. Adequately treated non\-melanoma skin cancer or lentigo maligna without evidence of disease. Adequately treated cervical carcinoma in situ without evidence of disease. Adequately treated breast ductal carcinoma in situ without evidence of disease. Prostatic intraepithelial neoplasia without evidence of prostate cancer. Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ. Other malignancies which do not require systemic therapy, may be considered upon discussion with the medical monitor.
- •3\. History of solid organ transplantation.
- •4\. Major surgery within 28 days of study day 1\.
- •5\. Prior/Concomitant Therapy: Prior treatment with anti\-programmed death 1 (PD\-1\), anti\-PD\-L1, CTLA\-4 or other checkpoint inhibitor drugs.
- •6\. Anti\-tumor therapy (radiotherapy, chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 21 days prior to study day 1\. Note: Palliative radiotherapy is permitted.
- •7\. Live vaccine therapy within 4 weeks prior to study drug administration.
- •8\. Current treatment or within 14 days of day 1 with immunosuppressive corticosteroid defined as greater than 10 mg prednisone daily or equivalent. Corticosteroids with no or minimal systemic effect (such as topical or inhalation) are permitted. Note: Corticosteroids \> 10 mg prednisone used for management of contrast allergy for study scans is allowed.
- •9\. Prior/Concurrent Clinical Study Experience: Currently receiving treatment in another investigational device or drug study, or less than 21 days prior to study day 1 since ending treatment on another investigational device or drug study(ies).
- •10\. Diagnostic Assessments: Evidence of interstitial lung disease or active, non\-infectious pneumonitis.
Outcomes
Primary Outcomes
Not specified
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