A Study of TAS3351 in NSCLC Patients With EGFRmt

Non-Small Cell Lung Cancer Clinical Trial

— TAS3351  

Official title:

A Phase 1/2 Study of TAS3351 in Patients With Advanced Non-Small Cell Lung Cancer and EGFR Mutations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05765734
• Other study ID #: 10073010
• Secondary ID: 2022-502595-23
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 3, 2023
• Est. completion date: December 2027

Study information

• Verified date: November 2023
• Source: Taiho Oncology, Inc.
• Contact: Taiho Oncology, Inc
• Phone: 609-250-7336
• Email: clinicaltrialinfo[@]taihooncology.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• TAS3351 oral administration
TAS3351 will be administered orally

Locations

Country	Name	City	State
France	Institut Gustave Roussy	Villejuif cedex	Val De Marne
Germany	Universitaetsklinikum Koeln	Koeln	Nordrhein Westfalen
Italy	IEO Istituto Europeo di Oncologia	Milano
Japan	National Cancer Center Hospital East	Kashiwa-shi	Chiba-Ken
Japan	Cancer Institute Hospital of JFCR	Koto-Ku
Japan	Shizuoka Cancer Center	Sunto-gun	Shizuoka-Ken
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Asan Medical Center	Seul
Netherlands	Antoni van Leeuwenhoek	Amsterdam
Netherlands	Leiden University Medical Center (LUMC)	Leiden
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Universitario 12 de Octubre	Madrid
United Kingdom	The Christie Hospital	Manchester	Greater Manchester
United States	Next Oncology - Virginia	Fairfax	Virginia
United States	University of Texas M. D. Anderson Cancer Center	Houston	Texas
United States	Tennessee Oncology	Nashville	Tennessee
United States	Georgetown University - Lombardi Comprehensive Cancer Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Taiho Oncology, Inc.

Countries where clinical trial is conducted

United States,  France,  Germany,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Escalation: To investigate the safety and determine the recommended Phase 2 dose and dosing schedule of TAS3351	Adverse Events	baseline through cycle 1(each cycle is 21 days)
Primary	Dose Escalation: To investigate the safety and determine the recommended Phase 2 dose and dosing schedule of TAS3351	Incidence of dose limiting toxicities (DLTs)	baseline through cycle 1(each cycle is 21 days)
Primary	Dose Expansion: To explore the efficacy of TAS3351	Objective Response Rate (ORR)	estimated 9 months
Primary	Phase 2: To assess the efficacy of TAS3351	Objective Response Rate (ORR)	estimated 3 years
Secondary	Dose Escalation:To evaluate the antitumor activity of TAS3351	Objective response rate (ORR)	estimated 20 months
Secondary	Dose Escalation:To evaluate the antitumor activity of TAS3351	Duration of response (DoR)	estimated 20 months
Secondary	Dose Escalation:To evaluate the antitumor activity of TAS3351	Disease control rate (DCR)	estimated 20 months
Secondary	Dose Escalation: To evaluate the antitumor activity of TAS3351	Progression free survival (PFS)	estimated 20 months
Secondary	Dose Escalation: To evaluate the antitumor activity of TAS3351	Overall Survival (OS)	estimated 20 months
Secondary	Dose Escalation: To characterize the pharmacokinetics (PK) of TAS3351	Evaluate the maximum plasma concentration (Cmax)	Cycle 1 Day 1 through cycle 1 Day 15 (21-Day cycle)
Secondary	Dose Escalation: To characterize the pharmacokinetics (PK) of TAS3351	Area under the plasma concentration-time curve (AUC)	ECycle 1 Day 1 through cycle 1 Day 15 (21-Day cycle)
Secondary	Dose Expansion: To confirm the safety and tolerability of TAS3351 at the recommended phase 2 dose and dosing schedule	Adverse Events (AEs)	estimated 9 months
Secondary	Dose Expansion: To further explore the anti-tumor efficacy of TAS3351	Duration of response (DoR) by ICR	estimated 9 months
Secondary	Dose Expansion: To further explore the anti-tumor efficacy of TAS3351	Progression Free Survival (PFS) by ICR	estimated 9 months
Secondary	Dose Expansion: To further explore the anti-tumor efficacy of TAS3351	Disease Control Rate (DCR) by ICR	estimated 9 months
Secondary	Dose Expansion: To further explore the anti-tumor efficacy of TAS3351	Objective Response Rate (ORR) by Investigator Assessment	estimated 9 months
Secondary	Dose Expansion: To further explore the anti-tumor efficacy of TAS3351	Duration of Response (DoR) by Investigator Assessment	estimated 9 months
Secondary	Dose Expansion: To further explore the anti-tumor efficacy of TAS3351	Progression Free Survival (PFS) by Investigator Assessment	estimated 9 months
Secondary	Dose Expansion: To further explore the anti-tumor efficacy of TAS3351	Disease Control Rate (DCR) by Investigator Assessment	estimated 9 months
Secondary	Dose Expansion: To further explore the anti-tumor efficacy of TAS3351	Intracranial Objective Response Rate (icORR)	estimated 9 months
Secondary	Dose Expansion: To further explore the anti-tumor efficacy of TAS3351	Intracranial Duration of Response (icDOR)	estimated 9 months
Secondary	Dose Expansion: To further explore the anti-tumor efficacy of TAS3351	Overall survival (OS)	estimated 9 months
Secondary	Phase 2: To evaluate the safety and tolerability of TAS3351	Adverse Events (AEs)	estimated 3 years
Secondary	Phase 2: To further assess the efficacy of TAS3351	Duration of response (DoR) by ICR	estimated 3 years
Secondary	Phase 2: To further assess the efficacy of TAS3351	Progression Free Survival (PFS) by ICR	estimated 3 years
Secondary	Phase 2: To further assess the efficacy of TAS3351	Disease Control Rate (DCR) by ICR	estimated 3 years
Secondary	Phase 2: To further assess the efficacy of TAS3351	Objective Response Rate (ORR) by Investigator Assessment	estimated 3 years
Secondary	Phase 2: To further assess the efficacy of TAS3351	Duration of Response (DoR) by Investigator Assessment	estimated 3 years
Secondary	Phase 2: To further assess the efficacy of TAS3351	Progression Free Survival (PFS) by Investigator Assessment	estimated 3 years
Secondary	Phase 2: To further assess the efficacy of TAS3351	Disease Control Rate (DCR) by Investigator Assessment	estimated 3 years
Secondary	Phase 2: To further assess the efficacy of TAS3351	Intracranial Objective Response Rate (icORR)	estimated 3 years
Secondary	Phase 2: To further assess the efficacy of TAS3351	Intracranial Duration of Response (icDOR)	estimated 3 years
Secondary	Phase 2: To further assess the efficacy of TAS3351	Overall survival (OS)	estimated 3 years
Secondary	Phase 2:To evaluate patient reported outcomes (PROs)	responses to patient questionnaires	estimated 3 years