A Study of TAS3351 in NSCLC Patients With EGFRmt

Taiho Pharma

Status and phase: Terminated; Phase 1

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: TAS3351

Study type: Interventional

Funder types: Industry

Identifiers

NCT05765734

2022-502595-23-00 (Other Identifier)

10073010

Details and patient eligibility

About

This is a first-in-human, open label, Phase 1/2 study to investigate the safety and efficacy of TAS3351 in participants with advanced or metastatic non-small cell lung cancer (NSCLC) harboring an acquired C797S epidermal growth factor receptor (EGFR) mutation.

Full description

This study will be conducted in 3 parts (i.e. dose escalation, dose expansion, and a phase 2 portion). The dose escalation part will investigate the safety and determine the recommended phase 2 dose and the recommended dosing regimen of TAS3351 administered orally. The dose expansion part will explore the efficacy of TAS3351 in NSCLC participants with C797S EGFR mutations. The phase 2 part will assess the efficacy of TAS3351 in NSCLC participants with C797S EGFR mutations.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Locally advanced, non-resectable or metastatic NSCLC
• Have adequate organ function
• Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
• Has tumor tissue available to allow for analysis of EGFRmt status

Dose Escalation:

• Has any EGFRmt status

Dose Escalation back-fill part, Dose Expansion and Phase II:

• Has any sensitizing EGFRmt and a confirmed C797S EGFRmt
• Has measurable disease per response evaluation criteria in solid tumors, version 1.1 (RECIST v1.1)

Exclusion criteria

• Participating in medical research not compatible with this study
• Symptomatic and unstable central nervous system (CNS) metastases
• Have not recovered from prior cancer treatment
• Have a significant cardiac condition
• Are a pregnant or breastfeeding female
• A serious illness or medical condition
• Unable to swallow or digest pills

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 9 patient groups

Part A1: Dose Escalation: 50 mg

Experimental group

Description:

Participants received TAS3351 50 milligrams (mg), tablets, orally, once daily (QD), on Days 1-21 of each 21-day cycle, for maximum duration of 66 days.

Treatment:

Drug: TAS3351

Part A1: Dose Escalation: 100 mg

Experimental group

Description:

Participants received TAS3351 100 mg, tablets, orally, QD, on Days 1-21 of each 21-day cycle, for a maximum duration of 126 days.

Treatment:

Drug: TAS3351

Part A1: Dose Escalation: 200 mg

Experimental group

Description:

Participants received TAS3351 200 mg, tablets, orally, QD, on Days 1-21 of each 21-day cycle, for a maximum duration of 94 days.

Treatment:

Drug: TAS3351

Part A1: Dose Escalation: 350 mg

Experimental group

Description:

Participants received TAS3351 350 mg, tablets, orally, QD, on Days 1-21 of each 21-day cycle, for a maximum duration of 46 days.

Treatment:

Drug: TAS3351

Part A1: Dose Escalation: 500 mg

Experimental group

Description:

Participants received TAS3351 500 mg, tablets, orally, QD, on Days 1-21 of each 21-day cycle, for a maximum duration of 87 days.

Treatment:

Drug: TAS3351

Part A1: Dose Escalation: 700 mg

Experimental group

Description:

Participants were to receive TAS3351 700 mg, tablets, orally, QD, on Days 1-21 of each 21-day cycle.

Treatment:

Drug: TAS3351

Part A2: Backfill

Experimental group

Description:

Participants were to be enrolled in Part A2 (backfill) when a dose level in Part A1 was determined to be safe and preliminary antitumor activity was observed.

Treatment:

Drug: TAS3351

Part B: Dose Expansion

Experimental group

Description:

.NSCLC participants with C797S EGFR mutations were planned for enrollment in Part B (dose expansion) and were to receive the recommended Phase 2 dose established in Part A.

Treatment:

Drug: TAS3351

Part C: Phase 2

Experimental group

Description:

NSCLC participants with C797S EGFR mutations were planned for enrollment in Part C (Phase 2) and were to receive the recommended Phase 2 dose established in Part A

Treatment:

Drug: TAS3351