A Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination With Avelumab

NCT03409458

Last updated date
Study Location
Arizona
Phoenix, Arizona, 85054, United States
Contact
(617) 335-1794

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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(617) 335-1794

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-Small Cell Lung Cancer (NSCLC)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

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Advanced Information
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
  • 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.
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:
  • Drug: PT-112
  • Biological: avelumab
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
 (submitted: November 2, 2020)
96
Original Estimated Enrollment  ICMJE
 (submitted: January 23, 2018)
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:

  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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jason Summa(617) 335-1794[email protected]
Contact: Mariam Mahbob[email protected]
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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Phosplatin Therapeutics
Study Sponsor  ICMJE Phosplatin Therapeutics
Collaborators  ICMJE
  • Pfizer
  • EMD Serono
Investigators  ICMJE
Principal Investigator:Daniel D Karp, MDM.D. Anderson Cancer Center
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