Phase I/Ib Study of GWN323 Alone and in Combination With PDR001 in Patients With Advanced Malignancies and Lymphomas
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer, Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/20/2019 |
| Start Date: | July 22, 2016 |
| End Date: | December 5, 2019 |
A Phase I/Ib Open-label, Multi-center, Dose Escalation Study of GWN323 (Anti-GITR) as a Single Agent and in Combination With PDR001 (Anti-PD-1) in Patients With Advanced Solid Tumors and Lymphomas
The purpose of this trial is to explore the clinical utility of two investigational
antibodies in patients with advanced cancer or lymphomas.
This is a multi-center, open-label Phase I/Ib study. The study consists of two dose
escalation parts and two dose expansion parts testing GWN323 as a single agent or GWN323 in
combination with PDR001. The dose escalation parts will estimate the MTD and/or RDE and test
different dosing schedules.
The dose expansion parts of the study will use the MTD/RDE determined in the dose escalation
part to assess the activity, safety and tolerability of the investigational products in
patients with specific types of cancer and lymphomas.
Approximately 264 adult patients with advanced solid tumors or lymphomas will be enrolled.
antibodies in patients with advanced cancer or lymphomas.
This is a multi-center, open-label Phase I/Ib study. The study consists of two dose
escalation parts and two dose expansion parts testing GWN323 as a single agent or GWN323 in
combination with PDR001. The dose escalation parts will estimate the MTD and/or RDE and test
different dosing schedules.
The dose expansion parts of the study will use the MTD/RDE determined in the dose escalation
part to assess the activity, safety and tolerability of the investigational products in
patients with specific types of cancer and lymphomas.
Approximately 264 adult patients with advanced solid tumors or lymphomas will be enrolled.
Inclusion Criteria:
- Patients with metastatic and/or advanced solid tumors or lymphomas not amenable to
curative treatment by surgery.
- Histologically documented advanced or metastatic solid tumors or lymphomas
- Must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy
according to the treating institution's guidelines. Patient must be willing to undergo
a new tumor biopsy at screening
- ECOG Performance Status ≤ 2.
Exclusion Criteria:
- Presence of symptomatic central nervous system (CNS) metastases, or CNS metastases
that require local CNS-directed therapy (such as radiotherapy or surgery).
- Patients diagnosed with T-cell Lymphomas.
- Patients with prior allogenic transplants.
- Patients previously treated with anti-GITR therapy.
- History of severe hypersensitivity reactions to other mAbs.
- Patients intolerant to prior immunotherapy (unable to continue/receive due to
immune-related AE).
Other protocol-defined inclusion/exclusion criteria may apply.
We found this trial at
5
sites
230 Park Avenue, 21st Floor
New York, New York 10169
New York, New York 10169
1-888-669-6682)
Principal Investigator: Alexander Lesokhin
Phone: 646-227-2178
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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Boston, Massachusetts 02118
Principal Investigator: Osama Rahma
Phone: 617-632-4272
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Chicago, Illinois 60612
Principal Investigator: Jason Luke
Phone: 773-702-8582
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Houston, Texas 77030
Principal Investigator: Sarina Piha-Paul
Phone: 713-563-4667
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