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

NCT ID: NCT03409458

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-24
• Study Completion Date: 2022-08-31

Brief Summary

This is a Phase 1/2, 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 1/2, 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 and the Dose Confirmation Phase.

Enrollment for dose escalation and dose confirmation is complete.

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 are eligible for the dose confirmation phase of the study.

Group Type: EXPERIMENTAL

PT-112

Intervention Type: DRUG

The RP2D of PT-112 when used in combination with avelumab has been determined during dose escalation and is being confirmed in the NSCLC dose confirmation cohort.

For the NSCLC confirmation cohort, PT-112 will be administered at a dose of 360 mg/m2 on Days 1, 8 and 15.

avelumab

Intervention Type: BIOLOGICAL

Avelumab will be administered at a fixed dose of 800 mg on Days 1 and 15.

Interventions

PT-112

The RP2D of PT-112 when used in combination with avelumab has been determined during dose escalation and is being confirmed in the NSCLC dose confirmation cohort.

For the NSCLC confirmation cohort, PT-112 will be administered at a dose of 360 mg/m2 on Days 1, 8 and 15.

Intervention Type: DRUG

avelumab

Avelumab will be administered at a fixed dose of 800 mg on Days 1 and 15.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Histologically or cytologically confirmed metastatic or locally advanced, squamous or non-squamous NSCLC (NSCLC). Patients must have received no more than four prior lines of therapy, including a PD-1 / PD-L1-containing therapy and a platinum containing regimen. Patients must have received no more than one taxane containing regimen and no more than one investigational agent;

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

EMD Serono

INDUSTRY

Sponsor Role: collaborator

Promontory Therapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel D Karp, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

Arizona

Phoenix, Arizona, United States

Colorado

Aurora, Colorado, United States

Florida

Jacksonville, Florida, United States

Minnesota

Rochester, Minnesota, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Lausanne

Lausanne, , Switzerland

Countries

United States; Switzerland

Other Identifiers

PT-112-103-PAVE-1

Identifier Type: -

Identifier Source: org_study_id