Status:
COMPLETED
A Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination With Avelumab
Lead Sponsor:
Promontory Therapeutics Inc.
Collaborating Sponsors:
Pfizer
EMD Serono
Conditions:
Non-Small Cell Lung Cancer (NSCLC)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a Phase 1/2, open-label, multi-center, non-randomized, dose-escalation study of PT-112 in combination with the anti-PD-L1 antibody, avelumab, in selected advanced solid tumors. The study is t...
Detailed Description
This is a Phase 1/2, open-label, multi-center, non-randomized, dose-escalation study of PT-112 in combination with the anti-PD-L1 antibody, avelumab, in selected advanced solid tumors. The study is to...
Eligibility Criteria
Inclusion
- Key
- Histologically or cytologically confirmed metastatic or locally advanced, squamous or non-squamous NSCLC (NSCLC). Patients must have received no more than four prior lines of therapy, including a PD-1 / PD-L1-containing therapy and a platinum containing regimen. Patients must have received no more than one taxane containing regimen and no more than one investigational agent;
- Must provide study-related tumor specimens;
- ECOG(PS) 0-1;
- Estimated Life Expectancy \> 3 months;
- Adequate bone marrow (BM), renal, hepatic and metabolic function.
- Key
Exclusion
- Concurrent cancer treatment with cytoreductive therapy, radiotherapy, cytokine therapy, cytotoxic agents, targeted small molecule therapy or any investigational anticancer small molecule drugs within 2 weeks prior to the start of study treatment (except 5 weeks from last dose of nitrosourea compound) OR treatment with monoclonal antibodies within 4 weeks prior to the start of study treatment;
- Known symptomatic central nervous system (CNS) metastases requiring steroids.
- Diagnosis of any other malignancy within 2 years prior to enrollment;
- Vaccination within 4 weeks of the first dose of study treatment is prohibited except for administration of inactivated vaccines;
- Current use of immunosuppressive medication at study entry;
- Active or prior autoimmune disease that might deteriorate with receiving an immunostimulatory agent;
- Acute or chronic infections requiring systemic therapy;
- Known history of autoimmune colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis;
- Known intolerance to checkpoint inhibitor therapy, defined by the occurrence of an AE leading to drug discontinuation;
- Participation in other studies involving investigational drug(s) within 28 days prior to study entry and/or during study participation.
Key Trial Info
Start Date :
April 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2022
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT03409458
Start Date
April 24 2018
End Date
August 31 2022
Last Update
November 18 2023
Active Locations (6)
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1
Arizona
Phoenix, Arizona, United States, 85054
2
Colorado
Aurora, Colorado, United States, 80045
3
Florida
Jacksonville, Florida, United States, 32224
4
Minnesota
Rochester, Minnesota, United States, 55905