A Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination With Avelumab
NCT03409458
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
(617) 335-1794
1. Histologically or cytologically proven metastatic or locally advanced disease. Specifically:
-patients with NSCLC, must have measurable disease by RECIST v1.1 criteria
2. Must provide study-related tumor specimens;
3. ECOG(PS) 0-1;
4. Estimated Life Expectancy > 3 months;
5. Adequate bone marrow (BM), renal, hepatic and metabolic function.
Key
1. 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;
2. Known symptomatic central nervous system (CNS) metastases requiring steroids.
3. Diagnosis of any other malignancy within 2 years prior to enrollment;
4. Vaccination within 4 weeks of the first dose of study treatment is prohibited except
for administration of inactivated vaccines;
5. Current use of immunosuppressive medication at study entry;
6. Active or prior autoimmune disease that might deteriorate with receiving an
immunostimulatory agent;
7. Acute or chronic infections requiring systemic therapy;
8. Known history of autoimmune colitis, inflammatory bowel disease, pneumonitis,
pulmonary fibrosis;
9. Known intolerance to checkpoint inhibitor therapy, defined by the occurrence of an AE
leading to drug discontinuation;
10. Participation in other studies involving investigational drug(s) within 28 days prior
to study entry and/or during study participation.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Phoenix, Arizona
- Aurora, Colorado
- Jacksonville, Florida
- Rochester, Minnesota
- Lausanne,
- Houston, Texas
- Birmingham, Alabama
- Los Angeles, California
- Los Angeles, California
Descriptive Information | |||||||||
---|---|---|---|---|---|---|---|---|---|
Brief Title ICMJE | A Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination With Avelumab | ||||||||
Official Title ICMJE | A Phase 1b/2a Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination With Avelumab | ||||||||
Brief Summary | This is a Phase 1b/2a, 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 be conducted in two parts: the Dose Escalation Phase of PT-112 within the combination and the Dose Confirmation Phase in patients with non-small cell lung cancer who will be treated at the RP2D. | ||||||||
Detailed Description | This is a Phase 1b/2a, 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 be conducted in two parts: the Dose Escalation Phase of PT-112 within the combination and the Dose Confirmation Phase. The Dose Escalation Phase will determine the Maximum Tolerated Dose (MTD) and recommended Phase 2 dose (RP2D) of PT-112 in the combination with avelumab, and will evaluate the PK, safety and tolerability, and efficacy. The Dose Confirmation Phase will evaluate patients with non-small cell lung cancer who will be treated at the RP2D. | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 1 Phase 2 | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||||
Condition ICMJE | Non-Small Cell Lung Cancer (NSCLC) | ||||||||
Intervention ICMJE |
| ||||||||
Study Arms ICMJE | Experimental: PT-112 in combination with avelumab
PT-112, administered by intravenous infusion avelumab, administered by intravenous infusion Patients with all listed conditions are eligible for treatment during the dose escalation phase of the study. Patients with NSCLC are eligible for the dose confirmation phase of the study. Interventions:
| ||||||||
Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||||
Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE | 96 | ||||||||
Original Estimated Enrollment ICMJE | 52 | ||||||||
Estimated Study Completion Date ICMJE | November 1, 2021 | ||||||||
Estimated Primary Completion Date | June 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Key Inclusion Criteria:
Key Exclusion Criteria:
| ||||||||
Sex/Gender ICMJE |
| ||||||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
| ||||||||
Listed Location Countries ICMJE | Switzerland, United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03409458 | ||||||||
Other Study ID Numbers ICMJE | PT-112-103-PAVE-1 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
| ||||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||||
Responsible Party | Phosplatin Therapeutics | ||||||||
Study Sponsor ICMJE | Phosplatin Therapeutics | ||||||||
Collaborators ICMJE |
| ||||||||
Investigators ICMJE |
| ||||||||
PRS Account | Phosplatin Therapeutics | ||||||||
Verification Date | November 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |