A Phase 1/2, open-label, multi-center study of the safety and efficacy ofKY1044 as single agent and in combination with anti-PD-L1 (atezolizumab) in adult patients with selected advanced malignancies

Kymab Ltd0 sites412 target enrollmentDecember 17, 2018

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Advanced/metastatic malignancies, and preferred indications: head and neck squamous cell carcinoma (HNSCC), non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC), esophageal cancer, gastric cancer, melanoma, renal cell cancer, pancreatic cancer, cervical cancer, and triple negative breast cancer (BC)
Sponsor: Kymab Ltd
Enrollment: 412
Status: Active, not recruiting
Last Updated: 5 years ago

No summary available.

Registry

who.int

Start Date

December 17, 2018

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Patients eligible for inclusion in this study must meet all of the following criteria:
•1\. Written informed consent must be obtained prior to any procedures
•2\. Age \=18 years (\=20 years in Taiwan)
•3\. Histologically documented advanced/metastatic malignancies
•4\. Phase 1 and Phase 2 patients with advanced/metastatic malignancies who have measurable disease (non\-measurable disease is allowed only in Phase 1\) as determined by RECIST 1\.1 (refer to Appendix 2\) will be eligible if, according to the NCCN guidelines, there are no available therapies known to confer a clinical benefit for their disease, or they have exhausted all such available options. Additionally, the following specific tumor indications will be enrolled:
•a.Phase 1 (including enrichment part):
•Patients with advanced/metastatic malignancies, and preferred indications as identified in Section 3\.1 (NSCLC, HNSCC, HCC, melanoma, cervical, gastric/esophageal, gastric, renal, pancreatic, and triple negative BC)
•b.Phase 2 KY1044 single agent:
•Patients with advanced/metastatic malignancies in indications in which signs of anti tumor activity (CR, PR or durable SD with tumor shrinkage that does not qualify for PR) were seen during the dose escalation of KY1044 as single agent.
•c.Phase 2 KY1044 in combination with atezolizumab:

•Patients eligible for this study must not meet any of the following criteria:
•1\. Presence of symptomatic CNS metastases, or CNS metastases that require local CNS\-directed therapy, or increasing doses of corticosteroids within the prior 2 weeks of first dose of study treatment. Patients with treated brain metastasis unless neurologically stable (for 4 weeks post\-treatment and prior
•to study enrolment) and off of steroids for at least 2 weeks before the first dose of study treatment
•2\. History of severe hypersensitivity reactions to other mAbs and/or their excipients
•3\. Known presence of neutralizing anti\-atezolizumab antibodies (for patients previously treated with atezolizumab)
•4\. Having out of range laboratory values (creatinine, bilirubin, ALT, AST, Absolute neutrophil count , Platelet count, Hemoglobin)
•5\. Impaired cardiac function or clinically significant cardiac disease, including any of the following:
•\- Clinically significant and/or uncontrolled heart disease such as congestive heart failure requiring treatment, uncontrolled hypertension or clinically significant arrhythmia
•\- QTcF \>470 msec on screening ECG or congenital long QT syndrome
•\- Acute myocardial infarction or unstable angina pectoris \<3 months prior to first dose of study treatment