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

Turning Point Therapeutics

Status and phase: Terminated; Phase 1

Conditions: Advanced Solid Tumor; ALK Gene Mutation; Non Small Cell Lung Cancer; Metastatic Solid Tumor; NSCLC; Non-Small Cell Lung Cancer

Treatments: Drug: TPX-0131

Study type: Interventional

Funder types: Industry

Identifiers

NCT04849273

TPX-0131-01

CA226-1036 (Other Identifier)

Details and patient eligibility

About

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).

Full description

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

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

TPX-0131

Experimental group

Description:

The Phase 1 part of the study will determine the safety, tolerability, PK, MTD, and RP2D of TPX-0131.

Treatment:

Drug: TPX-0131