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Trial record 1 of 5 for:    PT-112
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A Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination With Avelumab (PAVE-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03409458
Recruitment Status : Recruiting
First Posted : January 24, 2018
Last Update Posted : November 4, 2020
Sponsor:
Collaborators:
Pfizer
EMD Serono
Information provided by (Responsible Party):
Phosplatin Therapeutics

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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer (NSCLC) Drug: PT-112 Biological: avelumab Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b/2a Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination With Avelumab
Actual Study Start Date : April 24, 2018
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : November 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Avelumab

Arm Intervention/treatment
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.

Drug: PT-112
The MTD and RP2D of PT-112 when used in combination with avelumab will be determined during dose escalation.

Biological: avelumab
Avelumab will be administered at a fixed dose of 800 mg.




Primary Outcome Measures :
  1. Recommended dose (RD) of PT-112 to be used in combination with avelumab for further studies in patients with advanced solid tumors. [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Peak Plasma concentration (Cmax) for PT-112 Injection [ Time Frame: 24 months ]
  2. Area under the plasma concentration versus time curve (AUC) for PT-112 Injection [ Time Frame: 24 months ]
  3. Dose-limiting toxicities (DLTs) [ Time Frame: 24 months ]
  4. Number of patients with Adverse Events (AEs) [ Time Frame: 24 months ]
  5. Tumor burden Assessment [ Time Frame: 24 months ]
    To be assessed by iRECIST criteria for NSCLC

  6. Objective Response Rate (ORR) [ Time Frame: 24 months ]
  7. Disease Control Rate (DCR) [ Time Frame: 24 months ]
  8. Median Progression-free Survival (mPFS) [ Time Frame: 24 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  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 Exclusion Criteria:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03409458


Contacts
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Contact: Jason Summa (617) 335-1794 jsumma@phosplatin.com
Contact: Mariam Mahbob mmahbob@phosplatin.com

Locations
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United States, Arizona
Arizona Recruiting
Phoenix, Arizona, United States, 85054
United States, Colorado
Colorado Recruiting
Aurora, Colorado, United States, 80045
United States, Florida
Florida Recruiting
Jacksonville, Florida, United States, 32224
United States, Minnesota
Minnesota Recruiting
Rochester, Minnesota, United States, 55905
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Daniel D. Karp, MD         
Switzerland
Lausanne Recruiting
Lausanne, Switzerland, 1011
Sponsors and Collaborators
Phosplatin Therapeutics
Pfizer
EMD Serono
Investigators
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Principal Investigator: Daniel D Karp, MD M.D. Anderson Cancer Center
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Responsible Party: Phosplatin Therapeutics
ClinicalTrials.gov Identifier: NCT03409458    
Other Study ID Numbers: PT-112-103-PAVE-1
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Phosplatin Therapeutics:
Advanced Solid Tumors
NSCLC
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases