JOURNAL ONKOLOGIE – STUDIE
PAVE-1 A Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination With Avelumab
Indikation (Clinical Trials):
Carcinoma, Non-Small-Cell Lung
Pfizer, EMD Serono,
Studienlocations (3 von 6)
United StatesRekrutierend» Google-MapsColorado
United StatesRekrutierend» Google-MapsFlorida
United StatesRekrutierend» Google-Maps
United StatesRekrutierend» Google-MapsUniversity of Texas MD Anderson Cancer Center
United StatesRekrutierend» Google-MapsLausanne
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.
1. Histologically or cytologically proven metastatic or locally advanced disease.
-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
7. Acute or chronic infections requiring systemic therapy;
8. Known history of autoimmune colitis, inflammatory bowel disease, pneumonitis,
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.
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)
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)
The MTD and RP2D of PT-112 when used in combination with avelumab will be determined during dose escalation.
Avelumab will be administered at a fixed dose of 800 mg.