Clinical Trials /

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

NCT03409458

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 in patients with non-small cell lung cancer who will be treated at the RP2D.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination With Avelumab
  • Official Title: A Phase 1b/2a Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination With Avelumab

Clinical Trial IDs

  • ORG STUDY ID: PT-112-103-PAVE-1
  • NCT ID: NCT03409458

Conditions

  • Non-Small Cell Lung Cancer (NSCLC)

Interventions

DrugSynonymsArms
PT-112PT-112 in combination with avelumab
avelumabPT-112 in combination with avelumab

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
PT-112 in combination with avelumabExperimentalPT-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.
  • PT-112
  • avelumab

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Peak Plasma concentration (Cmax) for PT-112 Injection
Time Frame:24 months
Safety Issue:
Description:
Measure:Area under the plasma concentration versus time curve (AUC) for PT-112 Injection
Time Frame:24 months
Safety Issue:
Description:
Measure:Dose-limiting toxicities (DLTs)
Time Frame:24 months
Safety Issue:
Description:
Measure:Number of patients with Adverse Events (AEs)
Time Frame:24 months
Safety Issue:
Description:
Measure:Tumor burden Assessment
Time Frame:24 months
Safety Issue:
Description:To be assessed by iRECIST criteria for NSCLC
Measure:Objective Response Rate (ORR)
Time Frame:24 months
Safety Issue:
Description:
Measure:Disease Control Rate (DCR)
Time Frame:24 months
Safety Issue:
Description:
Measure:Median Progression-free Survival (mPFS)
Time Frame:24 months
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Phosplatin Therapeutics

Trial Keywords

  • Advanced Solid Tumors
  • NSCLC

Last Updated

November 4, 2020