Study of Tarloxotinib in Pts With NSCLC (EGFR Exon 20 Insertion, HER2-activating Mutations) & Other Solid Tumors With NRG1/ERBB Gene Fusions

NCT03805841 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: RAIN-701
• Study Type: interventional
• Target: 41
• Locations: 3 countries
• Sites: 14

Brief Summary

Open-label, Phase 2, single treatment arm, 3 cohorts

Conditions

NSCLC, Stage IV; NSCLC Stage IIIB; NSCLC, Stage IIIC; NSCLC, Recurrent; EGFR Exon 20 Insertion Mutation; HER2-activating Mutation; ERBB Fusion; NRG1 Fusion

Outcome Measures

Primary Outcomes (1)

• ORR

  The primary objective of this study is to evaluate the objective response rate (ORR) of tarloxotinib according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for tumors assessed by CT or MRI: Complete Response (CR) - Disappearance of all target lesions and reduction in the short axis measurement of all pathologic lymph nodes to ≤10 mm. Partial Response (PR) - ≥30% decrease in the sum of the longest diameter of the target lesions compared with baseline. The overall response rate in each cohort will be estimated as the number of subjects with a confirmed objective response (CR or PR) divided by the number of enrolled subjects in each respective cohort.

  Through study completion, an average of 10 months.

Study Arms (1)

Active

EXPERIMENTAL

tarloxotinib bromide

Drug: tarloxotinib bromide

Interventions

tarloxotinib bromide DRUG

weekly intravenous infusion

Also known as: Tarlox, tarloxotinib

Active

Eligibility Criteria

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

You may qualify if:

• Histologically and/or cytologically confirmed primary diagnosis of NSCLC, Stage IV, Stage IIIB or IIIC not amenable to definitive curative intent therapy, or recurrent disease after prior diagnosis of Stage I-III disease. Cohort C locally advanced or metastatic solid tumor.
• Progression of disease on or after a platinum-based chemotherapy regimen (Cohorts A and B) or after standard of care (Cohort C)
• EGFR exon 20 insertion mutation (Cohort A) or HER2 activating mutation (Cohort B) or NRG1 or ERBB family gene fusions (Cohort C)
• Measurable disease according to RECIST v.1.1
• ECOG performance status of 0 or 1
• Serum creatinine ≤ 1.5 x ULN (or calculated creatinine clearance ≥ 60 mL/min using Cockcroft Gault equation)
• Total bilirubin: ≤ 1.5 x ULN or ≤ 3 x ULN in the presence of liver metastases
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN, or ≤ 5 x ULN, in the presence of liver metastases
• Absolute neutrophil count (ANC) ≥ 1,500 cells/μL
• Hemoglobin ≥ 9 g/dL or 5.6 mmol/L
• Platelet count ≥ 100,000/μL
• No evidence of second or third degree atrioventricular block
• No clinically significant arrhythmia (i.e.; pauses of \> 4 seconds, VT of any duration, SVT \> 4 beats/minute)
• QRS interval ≤ 110 ms
• QTcF interval of \< 450 ms

You may not qualify if:

• Another known activating oncogene driver mutation
• (Cohorts A and B Only) Previously received anti EGFR or anti HER2 tyrosine kinase inhibitors
• (Cohorts A and B Only) Previously received anti EGFR or anti HER2 monoclonal antibodies or EGFR or HER2 antibody drug conjugates
• Investigational therapy administered within the 28 days or 5 half lives
• Chemotherapy or radiation within 14 days prior to Cycle 1 Day 1
• Immunotherapy within 21 days
• Clinically active or symptomatic interstitial lung disease (ILD) or interstitial pneumonitis, or a history of clinically significant ILD or radiation pneumonitis
• Untreated and/or symptomatic CNS malignancies (primary or metastatic);
• Receiving medication that prolongs QT interval, with a risk of causing Torsade de Pointes (TdP)
• Personal or familial history of Long QT Syndrome
• NYHA class III or IV or LVEF \< 55%
• Myocardial infarction, severe or unstable angina within 6 months
• History of TdP, ventricular arrhythmia
• Significant thrombotic or embolic events within 3 months
• Uncontrolled or severe cardiovascular disease

Sponsors & Collaborators

• Rain Oncology Inc: lead

Study Sites (14)

RAIN-701 Study Site

Irvine, California, 92697, United States

Location

Pacific Shores Medical Group

Long Beach, California, 90813, United States

Location

University of California San Francisco, Helen Diller Cancer Center

San Francisco, California, 94158, United States

Location

RAIN-701 Study Site

Aurora, Colorado, 80045, United States

Location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Comprehensive Care and Research Center, Atlanta

Newnan, Georgia, 30265, United States

Location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Henry Ford Cancer Institute

Detroit, Michigan, 48202, United States

Location

Providence Cancer Institute

Portland, Oregon, 97213, United States

Location

RAIN-701 Study Site

Pittsburgh, Pennsylvania, 15232, United States

Location

RAIN-701 Study Site

Seattle, Washington, 98109, United States

Location

RAIN-701 Study Site

Toronto, Ontario, M5G 2C1, Canada

Location

RAIN-701 Study Site

Hong Kong, Hong Kong

Location

Hong Kong United Oncology Center

Kowloon, Hong Kong

Location

Related Publications (1)

• Ye L, Chen X, Zhou F. EGFR-mutant NSCLC: emerging novel drugs. Curr Opin Oncol. 2021 Jan;33(1):87-94. doi: 10.1097/CCO.0000000000000701.

  PMID: 33122578 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Recurrence

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Rain Oncology Inc.

info@rainoncology.com

(510) 953-5559

Study Officials

• Stephen V Liu, MD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: January 16, 2019
• Study Start: March 13, 2019
• Primary Completion: April 9, 2021
• Study Completion: April 23, 2021
• Last Updated: June 28, 2023
• Results First Posted: June 28, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (11); HK (2)