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

NCT03409458

Last updated date
Study Location
Mayo Clinic
Phoenix, Arizona, 85054, United States
Contact
(919) 867-1616

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Pfizer Clinical Trials Contact Center

(919) 867-1616

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), Urothelial Carcinoma (UC), Squamous Cell Carcinoma of the Head and Neck (SCCHN), Metastatic Breast Cancer (mBC), Castration-resistant Prostate Cancer (CRPC)
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, UC, mBC, or SCCHN must have measurable disease by RECIST v1.1 criteria with at least one uni-dimensional measurable lesion;

- patients with CRPC must meet PCWG3 criteria for disease progression at trial entry

2. Availability of tumor specimens is mandatory for patients in the confirmation phase;

2 ECOG Performance Status (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, with the following
exceptions:


- PD-1 / PD-L1 checkpoint inhibitor therapy is permitted;


- Palliative bone-directed radiotherapy is permitted unless involving an area of ≥
25% of bone marrow reserves and occurring within 5 weeks prior to the start of
study treatment;


- Erythropoietin and darbopoietin-α are permitted;


- Hormonal therapies acting on the hypothalamic-pituitary-gonadal axis (i.e., LHRH
agonist/antagonist) are permitted. No other hormonal therapy is permitted;


2. Known symptomatic central nervous system (CNS) metastases requiring steroids. Patients
with previously diagnosed CNS metastases are eligible if they (1) have completed their
treatment and have recovered from the acute effects of radiation therapy and/or
surgery prior to enrollment, (2) have discontinued corticosteroid treatment for these
metastases for at least 14 days, and (3) are neurologically stable;


3. Diagnosis of any other malignancy within 2 years prior to enrollment. However,
adequately treated basal cell or squamous cell skin cancer or non-invasive superficial
bladder cancer or carcinoma in situ of the bladder, breast or cervix; or prostate
cancer of low grade (Gleason ≤6) or surveillance without any plans for treatment
intervention (e.g., surgery, radiation, or castration) are allowed;


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, with the following
exceptions:


- Intranasal, inhaled, or topical steroids or local steroid injections (eg,
intra-articular injection) are permitted;


- Systemic corticosteroids at physiologic doses ≤10 mg/day of prednisone or
equivalent are permitted;


- Steroids as premedication for hypersensitivity reactions are permitted;


6. Active or prior autoimmune disease that might deteriorate with receiving an
immunostimulatory agent. However, patients with diabetes type 1, vitiligo, psoriasis,
or hypo- or hyper-thyroid disease not requiring immunosuppressive treatment are
eligible;


7. Acute or chronic infections requiring systemic therapy, including, among others:


- Active infection requiring systemic therapy;


- History of testing positive to human immunodeficiency virus (HIV) or known
acquired immunodeficiency syndrome;


- Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening
(positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test is
positive);


- Active tuberculosis (history of exposure or history of positive TB test with
presence of clinical symptoms, physical or radiographic finding);


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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Pfizer Clinical Trials Contact Center

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Non Small Cell Lung Cancer (NSCLC), Urothelial Carcinoma (UC), Squamous Cell Carcinoma of the Head and Neck (SCCHN), Metastatic Breast Cancer (mBC), Castration-resistant Prostate Cancer (CRPC)A Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination With Avelumab
NCT03409458
  1. Phoenix, Arizona
  2. Aurora, Colorado
  3. Jacksonville, Florida
  4. Rochester, Minnesota
  5. Houston, Texas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
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. The Dose Escalation Phase will determine the Maximum Tolerated Dose (MTD) and recommended Phase 2 dose (RP2D) of PT-112 in the combination as avelumab will be administered at a flat dose of 800 mg. The trial will evaluate the PK (pharmacokinetic) effects of PT-112 and the safety and tolerability of the combination as well as preliminary clinical effects. The Dose Confirmation Phase will consist of two additional cohorts in patients with non-small cell lung cancer or urothelial carcinoma who will be treated at or below the MTD of PT-112 in the combination.
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 as avelumab will be administered at a flat dose of 800 mg. The trial will evaluate the PK (pharmacokinetic) effects of PT-112 and the safety and tolerability of the combination as well as preliminary clinical effects. The Dose Confirmation Phase will consist of two additional cohorts in patients with non-small cell lung cancer or urothelial carcinoma who will be treated at or below the MTD of PT-112 in the combination.
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)
  • Urothelial Carcinoma (UC)
  • Squamous Cell Carcinoma of the Head and Neck (SCCHN)
  • Metastatic Breast Cancer (mBC)
  • Castration-resistant Prostate Cancer (CRPC)
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 and mUC 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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 23, 2018)
52
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2020
Estimated Primary Completion Date February 1, 2020   (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, UC, mBC, or SCCHN must have measurable disease by RECIST v1.1 criteria with at least one uni-dimensional measurable lesion;
    • patients with CRPC must meet PCWG3 criteria for disease progression at trial entry
  2. Availability of tumor specimens is mandatory for patients in the confirmation phase;

2 ECOG Performance Status (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, with the following exceptions:

    • PD-1 / PD-L1 checkpoint inhibitor therapy is permitted;
    • Palliative bone-directed radiotherapy is permitted unless involving an area of ? 25% of bone marrow reserves and occurring within 5 weeks prior to the start of study treatment;
    • Erythropoietin and darbopoietin-? are permitted;
    • Hormonal therapies acting on the hypothalamic-pituitary-gonadal axis (i.e., LHRH agonist/antagonist) are permitted. No other hormonal therapy is permitted;
  2. Known symptomatic central nervous system (CNS) metastases requiring steroids. Patients with previously diagnosed CNS metastases are eligible if they (1) have completed their treatment and have recovered from the acute effects of radiation therapy and/or surgery prior to enrollment, (2) have discontinued corticosteroid treatment for these metastases for at least 14 days, and (3) are neurologically stable;
  3. Diagnosis of any other malignancy within 2 years prior to enrollment. However, adequately treated basal cell or squamous cell skin cancer or non-invasive superficial bladder cancer or carcinoma in situ of the bladder, breast or cervix; or prostate cancer of low grade (Gleason ?6) or surveillance without any plans for treatment intervention (e.g., surgery, radiation, or castration) are allowed;
  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, with the following exceptions:

    • Intranasal, inhaled, or topical steroids or local steroid injections (eg, intra-articular injection) are permitted;
    • Systemic corticosteroids at physiologic doses ?10 mg/day of prednisone or equivalent are permitted;
    • Steroids as premedication for hypersensitivity reactions are permitted;
  6. Active or prior autoimmune disease that might deteriorate with receiving an immunostimulatory agent. However, patients with diabetes type 1, vitiligo, psoriasis, or hypo- or hyper-thyroid disease not requiring immunosuppressive treatment are eligible;
  7. Acute or chronic infections requiring systemic therapy, including, among others:

    • Active infection requiring systemic therapy;
    • History of testing positive to human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome;
    • Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test is positive);
    • Active tuberculosis (history of exposure or history of positive TB test with presence of clinical symptoms, physical or radiographic finding);
  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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE 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
Plan to Share IPD:Undecided
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 September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP