MP0250 DARPin® Protein Plus Osimertinib in Patients With EGFR-mutated NSCLC

NCT03418532 | Terminated Phase 1 FDA Drug

• 1 other identifier: MP0250-CP202
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 10

Brief Summary

The purpose of this study is to assess the anti-tumor efficacy, safety, tolerability, pharmacokinetics (PK), immunogenicity and biological activity of the MP0250 DARPin® drug candidate in combination with osimertinib orally once daily (o.d.), when administered to patients with EGFR mutated, advanced, non squamous NSCLC after tumor progression on osimertinib and on or after the most recent therapy. MP0250 is a multi-DARPin® protein with three specificities, able to simultaneously neutralize the activities of vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF) and also to bind to human serum albumin (HSA) to give an increased plasma half-life and potentially enhanced tumor penetration.

Conditions

EGFR-mutated NSCLC (Disorder)

Keywords

DARPin®protein; MP0250; VEGF; HGF; NSCLC; EGFR mutated; Osimertinib

Outcome Measures

Primary Outcomes (1)

• Estimate the objective response rate (ORR)

  Tumor response will be assessed based on RECIST 1.1 by using CT or MRI

  6 months

Secondary Outcomes (10)

• Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to CTCAE, v4.03.

  15 months

• progression free survival (PFS)

  12 months

• duration of response (DOR)

  9 months

• overall survival (OS)

  24 months

• time to response (TTR)

  4 months

Other Outcomes (2)

• biomarkers in tissue

  12 months

• biomarkers in blood

  12 months

Study Arms (1)

single arm

EXPERIMENTAL

MP0250 DARPin® drug candidate (6 mg/kg or 8 mg/kg or 12 mg/kg, infusion) on day 1 of each 21 day cycle. Osimertinib according to label

Combination Product: MP0250 DARPin® drug candidate, Osimertinib

Interventions

MP0250 DARPin® drug candidate, Osimertinib COMBINATION_PRODUCT

Number of Cycles: until progression, unacceptable toxicity or other reasons for withdrawal

single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed metastatic or unresectable locally advanced non-squamous NSCLC with documented EGFR mutation-positive disease
• Radiologically documented disease progression on previous osimertinib treatment.
• Radiologically documented disease progression on or after most recent antitumor therapy.
• Measurable disease according to RECIST 1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 2.
• Men and women ≥18 years old on the day of signing informed consent.
• Adequate hematological, hepatic and renal function prior to first dose
• Serum albumin concentration ≥30 g/L
• Potassium and magnesium within normal range

You may not qualify if:

• Necrotic tumors or tumors close to large blood vessels that may impose an increased bleeding risk when treated with anti-VEGF agents.
• Second malignancy that is currently clinically significant or required active intervention during the period of 12 months prior to Screening, except early stage non-melanoma skin cancer treated with curative intent.
• Known pre-existing interstitial or inflammatory lung disease.
• Clinical signs of or documented leptomeningeal carcinomatosis. Features such as headache, nuchal rigidity, and photophobia may indicate meningeal involvement.
• Known brain metastases who are clinically unstable
• Prohibited anti-NSCLC therapies and not having recovered from related AEs to Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤1
• Any investigational drug within 28 days prior to study treatment.
• Current participation in any other interventional clinical study (except survival follow up).
• Neuropathy as residual toxicity after prior antitumor therapy Grade \>2
• Patients taking medications that have the potential to prolong the QT interval
• Significant cardiac abnormalities
• Uncontrolled hypertension
• Significant risk for bleeding
• Active or recent thrombolic events

Sponsors & Collaborators

• Molecular Partners AG: lead

Study Sites (10)

Scottsdale Healthcare Hospitals

Scottsdale, Arizona, 85258, United States

Location

City of Hope - Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

University of California

San Diego, California, 92093, United States

Location

UCLA Medical Center

Santa Monica, California, 90404, United States

Location

Georgetown University

Washington D.C., District of Columbia, 20057, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

Duke Cancer Institute

Durham, North Carolina, 27710, United States

Location

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Oncology Consultants

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

osimertinib

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The trial was intended to be a Phase 1/2 trial. Trial was terminated before Phase 2 commenced.

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: February 1, 2018
• Study Start: March 22, 2018
• Primary Completion: August 30, 2019
• Study Completion: April 24, 2020
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)