A Study of TAS3351 in NSCLC Patients With EGFRmt

Phase 1

Recruiting

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Drug: TAS3351 oral administration

• Registration Number: NCT05765734
• Lead Sponsor: Taiho Oncology, Inc.

Brief Summary

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

Detailed 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 patients with C797S EGFR mutations. The phase 2 part will assess the efficacy of TAS3351 in NSCLC patients with C797S EGFR mutations.

Study Timeline

• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-03-08
• Study First Posted: 2023-03-13
• Study Start: 2023-05-25
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-29
• Last Update Posted: 2024-12-02
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 RECIST v1.1

Exclusion Criteria

• Participating in medical research not compatible with this study
• Symptomatic and unstable 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TAS3351 Part C (Phase 2)	TAS3351 oral administration	To assess efficacy of TAS3351 in NSCLC patients with C797S EGFRmt. TAS3351 will be administered at the recommended phase 2 dose.
TAS3351 Part B (Dose Expansion)	TAS3351 oral administration	TAS3351 in NSCLC patients with C797S EGFRmt. TAS3351 will be administered at the recommended phase 2 dose determined in Part A.
TAS3351 Part A (Dose Escalation)	TAS3351 oral administration	Dose escalation will assess the safety and determine the recommended phase 2 dose and regimen of TAS3351 administered orally.

Primary Outcome Measures

Name	Time	Method
Dose Expansion: To explore the efficacy of TAS3351	estimated 9 months	Objective Response Rate (ORR)
Dose Escalation: To investigate the safety and determine the recommended Phase 2 dose and dosing schedule of TAS3351	baseline through cycle 1(each cycle is 21 days)	Incidence of dose limiting toxicities (DLTs)
Phase 2: To assess the efficacy of TAS3351	estimated 3 years	Objective Response Rate (ORR)

Secondary Outcome Measures

Name	Time	Method
Phase 2:To evaluate patient reported outcomes (PROs)	estimated 3 years	responses to patient questionnaires
Dose Escalation: To characterize the pharmacokinetics (PK) of TAS3351	ECycle 1 Day 1 through cycle 1 Day 15 (21-Day cycle)	Area under the plasma concentration-time curve (AUC)
Phase 2: To further assess the efficacy of TAS3351	estimated 3 years	Overall survival (OS)
Dose Escalation:To evaluate the antitumor activity of TAS3351	estimated 20 months	Disease control rate (DCR)
Dose Expansion: To further explore the anti-tumor efficacy of TAS3351	estimated 9 months	Overall survival (OS)
Dose Escalation: To evaluate the antitumor activity of TAS3351	estimated 20 months	Overall Survival (OS)
Dose Expansion: To confirm the safety and tolerability of TAS3351 at the recommended phase 2 dose and dosing schedule	estimated 9 months	Adverse Events (AEs)
Phase 2: To evaluate the safety and tolerability of TAS3351	estimated 3 years	Adverse Events (AEs)

Trial Locations

Locations (17)

Georgetown University - Lombardi Comprehensive Cancer Center; 🇺🇸 Washington, District of Columbia, United States

Tennessee Oncology; 🇺🇸 Nashville, Tennessee, United States

University of Texas M. D. Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Next Oncology - Virginia; 🇺🇸 Fairfax, Virginia, United States

Institut Gustave Roussy; 🇫🇷 Villejuif cedex, Val De Marne, France

Universitaetsklinikum Koeln; 🇩🇪 Koeln, Nordrhein Westfalen, Germany

IEO Istituto Europeo di Oncologia; 🇮🇹 Milano, Italy

National Cancer Center Hospital East; 🇯🇵 Kashiwa-shi, Chiba-Ken, Japan

Shizuoka Cancer Center; 🇯🇵 Sunto-gun, Shizuoka-Ken, Japan

Cancer Institute Hospital of JFCR; 🇯🇵 Koto-Ku, Japan

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seul, Korea, Republic of

Antoni van Leeuwenhoek; 🇳🇱 Amsterdam, Netherlands

Leiden University Medical Center (LUMC); 🇳🇱 Leiden, Netherlands

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

The Christie Hospital; 🇬🇧 Manchester, Greater Manchester, United Kingdom