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.
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
Drug | Synonyms | Arms |
---|
PT-112 | | PT-112 in combination with avelumab |
avelumab | | PT-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
Name | Type | Description | Interventions |
---|
PT-112 in combination with avelumab | Experimental | 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. | |
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