A Study of TAS3351 in NSCLC Patients With EGFRmt

Phase 2TerminatedNCT05765734

Taiho Oncology, Inc.18 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-Small Cell Lung Cancer

Interventions

TAS3351 oral administrationDRUG

TAS3351 will be administered orally

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (17)

Georgetown University - Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, United States

Tennessee Oncology

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Dose Escalation: To investigate the safety and determine the recommended Phase 2 dose and dosing schedule of TAS3351

Adverse Events

Time frame: baseline through cycle 1(each cycle is 21 days)

Dose Escalation: To investigate the safety and determine the recommended Phase 2 dose and dosing schedule of TAS3351

Incidence of dose limiting toxicities (DLTs)

Time frame: baseline through cycle 1(each cycle is 21 days)

Dose Expansion: To explore the efficacy of TAS3351

Objective Response Rate (ORR)

Time frame: estimated 9 months

Phase 2: To assess the efficacy of TAS3351

Objective Response Rate (ORR)

Time frame: estimated 3 years

Secondary Outcomes

Dose Escalation:To evaluate the antitumor activity of TAS3351

Objective response rate (ORR)

Time frame: estimated 20 months

Dose Escalation:To evaluate the antitumor activity of TAS3351

Duration of response (DoR)

Time frame: estimated 20 months

Dose Escalation:To evaluate the antitumor activity of TAS3351

Disease control rate (DCR)

Time frame: estimated 20 months

Dose Escalation: To evaluate the antitumor activity of TAS3351

Progression free survival (PFS)

Time frame: estimated 20 months

Data from ClinicalTrials.gov

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University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States

Next Oncology - Virginia

Fairfax, Virginia, United States

Institut Gustave Roussy

Villejuif, Val De Marne, France

Universitaetsklinikum Koeln

Cologne, North Rhine-Westphalia, Germany

IEO Istituto Europeo di Oncologia

Milan, Italy

National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan

Shizuoka Cancer Center

Sunto-gun, Shizuoka, Japan

Cancer Institute Hospital of JFCR

Kōtoku, Japan

...and 7 more locations

Dose Escalation: To evaluate the antitumor activity of TAS3351

Overall Survival (OS)

Time frame: estimated 20 months

Dose Escalation: To characterize the pharmacokinetics (PK) of TAS3351

Evaluate the maximum plasma concentration (Cmax)

Time frame: Cycle 1 Day 1 through cycle 1 Day 15 (21-Day cycle)

Dose Escalation: To characterize the pharmacokinetics (PK) of TAS3351

Area under the plasma concentration-time curve (AUC)

Time frame: ECycle 1 Day 1 through cycle 1 Day 15 (21-Day cycle)

Dose Expansion: To confirm the safety and tolerability of TAS3351 at the recommended phase 2 dose and dosing schedule

Adverse Events (AEs)

Time frame: estimated 9 months

Dose Expansion: To further explore the anti-tumor efficacy of TAS3351

Duration of response (DoR) by ICR

Time frame: estimated 9 months

Dose Expansion: To further explore the anti-tumor efficacy of TAS3351

Progression Free Survival (PFS) by ICR

Time frame: estimated 9 months

Dose Expansion: To further explore the anti-tumor efficacy of TAS3351

Disease Control Rate (DCR) by ICR

Time frame: estimated 9 months

Dose Expansion: To further explore the anti-tumor efficacy of TAS3351

Objective Response Rate (ORR) by Investigator Assessment

Time frame: estimated 9 months

Dose Expansion: To further explore the anti-tumor efficacy of TAS3351

Duration of Response (DoR) by Investigator Assessment

Time frame: estimated 9 months

Dose Expansion: To further explore the anti-tumor efficacy of TAS3351

Progression Free Survival (PFS) by Investigator Assessment

Time frame: estimated 9 months

Dose Expansion: To further explore the anti-tumor efficacy of TAS3351

Disease Control Rate (DCR) by Investigator Assessment

Time frame: estimated 9 months

Dose Expansion: To further explore the anti-tumor efficacy of TAS3351

Intracranial Objective Response Rate (icORR)

Time frame: estimated 9 months

Dose Expansion: To further explore the anti-tumor efficacy of TAS3351

Intracranial Duration of Response (icDOR)

Time frame: estimated 9 months

Dose Expansion: To further explore the anti-tumor efficacy of TAS3351

Overall survival (OS)

Time frame: estimated 9 months

Phase 2: To evaluate the safety and tolerability of TAS3351

Adverse Events (AEs)

Time frame: estimated 3 years

Phase 2: To further assess the efficacy of TAS3351

Duration of response (DoR) by ICR

Time frame: estimated 3 years

Phase 2: To further assess the efficacy of TAS3351

Progression Free Survival (PFS) by ICR

Time frame: estimated 3 years

Phase 2: To further assess the efficacy of TAS3351

Disease Control Rate (DCR) by ICR

Time frame: estimated 3 years

Phase 2: To further assess the efficacy of TAS3351

Objective Response Rate (ORR) by Investigator Assessment

Time frame: estimated 3 years

Phase 2: To further assess the efficacy of TAS3351

Duration of Response (DoR) by Investigator Assessment

Time frame: estimated 3 years

Phase 2: To further assess the efficacy of TAS3351

Progression Free Survival (PFS) by Investigator Assessment

Time frame: estimated 3 years

Phase 2: To further assess the efficacy of TAS3351

Disease Control Rate (DCR) by Investigator Assessment

Time frame: estimated 3 years

Phase 2: To further assess the efficacy of TAS3351

Intracranial Objective Response Rate (icORR)

Time frame: estimated 3 years

Phase 2: To further assess the efficacy of TAS3351

Intracranial Duration of Response (icDOR)

Time frame: estimated 3 years

Phase 2: To further assess the efficacy of TAS3351

Overall survival (OS)

Time frame: estimated 3 years

Phase 2:To evaluate patient reported outcomes (PROs)

responses to patient questionnaires

Time frame: estimated 3 years