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JOURNAL ONKOLOGIE – STUDIE

PAVE-1 A Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination With Avelumab

Rekrutierend

NCT-Nummer:
NCT03409458

Studienbeginn:
April 2018

Letztes Update:
04.11.2020

Wirkstoff:
PT-112, Avelumab

Indikation (Clinical Trials):
Carcinoma, Non-Small-Cell Lung

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Phosplatin Therapeutics

Collaborator:
Pfizer, EMD Serono,

Studienleiter

Daniel D Karp, MD
Principal Investigator
M.D. Anderson Cancer Center

Kontakt

Studienlocations (3 von 6)

University of Texas MD Anderson Cancer Center
77030 Houston
United StatesRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

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:

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)

Geprüfte Regime

  • PT-112:
    The MTD and RP2D of PT-112 when used in combination with avelumab will be determined during dose escalation.
  • avelumab:
    Avelumab will be administered at a fixed dose of 800 mg.

Quelle: ClinicalTrials.gov


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