A Study of TPX-0131, a Novel Oral ALK Tyrosine Kinase Inhibitor, in Patients With ALK+ Advanced or Metastatic NSCLC

Non-Small Cell Lung Cancer Clinical Trial

Official title:

A Phase 1/2 Study of TPX-0131, A Novel Oral ALK Tyrosine Kinase Inhibitor in Subjects With ALK+ Advanced or Metastatic NSCLC

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04849273
• Other study ID #: CA226-1036
• Secondary ID: CA226-1036TPX-01
• Status: Terminated
• Phase: Phase 1
• Start date: July 28, 2021
• Est. completion date: April 18, 2023

Study information

• Verified date: May 2023
• Source: Turning Point Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A phase 1, first-in-human, open-label study to evaluate the safety, tolerability, PK, and efficacy of the novel ALK inhibitor TPX-0131 in pretreated subjects with ALK+ advanced or metastatic non-small cell lung cancer (NSCLC).

Description:

Phase 1 Dose Escalation: To evaluate the overall safety profile, efficacy of TPX-0131 in pretreated subjects with ALK+ advanced or metastatic NSCLC.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: April 18, 2023
• Est. primary completion date: April 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 (or as required by local regulation).

• Histological or cytological confirmation of advanced/metastatic ALK+ NSCLC.

• Pretreated with up to three prior lines of an ALK TKI treatment, including at least one prior line of a second or third-generation ALK TKI (alectinib, brigatinib, ensartinib, or lorlatinib) in Phase 1.

• ECOG performance status = 1.

• Existence of measurable or evaluable disease (according to Response evaluation criteria in solid tumors [RECIST v1.1] criteria).

• Subjects with asymptomatic CNS metastases and/or asymptomatic leptomeningeal carcinomatosis are eligible.

• Adequate organ function.

Exclusion Criteria:

• Major surgery within four weeks of the start of TPX-0131 treatment.

• Clinically significant cardiovascular disease

• Any of the following cardiac criteria:

• Mean resting corrected QT interval (QTc) > 470 msec obtained from three ECGs and any factors that increase the risk of QTc prolongation or arrhythmic events

• Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG

• Known clinically significant active infections not controlled with systemic treatment (bacterial, fungal, viral including HIV positivity).

• Gastrointestinal disease or other malabsorption syndromes that would impact drug absorption.

• Subjects being treated with or anticipating the need for treatment with strong CYP3A4 inhibitors or inducers.

• Subjects with current or anticipated need for drugs that are sensitive CYP2C9 substrates with narrow therapeutic indices.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• ALK Gene Mutation
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Metastatic Solid Tumor
• Neoplasms
• Non Small Cell Lung Cancer
• Non-Small Cell Lung Cancer
• NSCLC

Intervention

Drug:
• TPX-0131
Oral TPX-0131 tablets

Locations

Country	Name	City	State
Australia	Local Institution - 6102	Blacktown	New South Wales
Australia	Local Institution - 6103	Heidelberg	Victoria
Australia	Local Institution - 6104	Melbourne	Victoria
Australia	Local Institution - 6101	Nedlands	Western Australia
Korea, Republic of	Local Institution - 6301	Seoul
Korea, Republic of	Local Institution - 6302	Seoul
Korea, Republic of	Local Institution - 6303	Seoul	Seoul-teukbyeolsi
Korea, Republic of	Local Institution - 6304	Seoul
United States	Local Institution - 2105	Aurora	Colorado
United States	Local Institution - 2106	Boston	Massachusetts
United States	Local Institution - 2108	Boston	Massachusetts
United States	Local Institution - 2102	Fairfax	Virginia
United States	Local Institution - 2103	Hackensack	New Jersey
United States	Local Institution - 2107	Nashville	Tennessee
United States	Local Institution - 2104	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
Turning Point Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of first cycle dose-limiting toxicities (DLTs) of TPX-0131	Evaluate the safety and tolerability of TPX-0131	Within 28 days of the first TPX-0131 dose for each patient
Primary	Define the Recommended Phase 2 Dose	Determine the maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of TPX-0131	Approximately 24 months
Secondary	Adverse events (AEs)	Evaluate the overall safety profile of TPX-0131	Approximately 34 months

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls