Clinical trial NCT05765734: A Study of TAS3351 in NSCLC Patients With EGFRmt
Official title: A Phase 1/2 Study of TAS3351 in Patients With Advanced Non-Small Cell Lung Cancer and EGFR Mutations
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer
NSCLC
EGFR mutation
C797S mutation
TAS3351
Lead sponsor: Taiho Oncology, Inc.
Sponsor class: INDUSTRY
First posted: 2023-03-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Dose Escalation: To investigate the safety and determine the recommended Phase 2 dose and dosing schedule of TAS3351
timeFrame: baseline through cycle 1(each cycle is 21 days)
measure: Dose Escalation: To investigate the safety and determine the recommended Phase 2 dose and dosing schedule of TAS3351
timeFrame: baseline through cycle 1(each cycle is 21 days)
measure: Dose Expansion: To explore the efficacy of TAS3351
timeFrame: estimated 9 months
measure: Phase 2: To assess the efficacy of TAS3351
timeFrame: estimated 3 years
Secondary outcomes:
measure: Dose Escalation:To evaluate the antitumor activity of TAS3351
timeFrame: estimated 20 months
measure: Dose Escalation:To evaluate the antitumor activity of TAS3351
timeFrame: estimated 20 months
measure: Dose Escalation:To evaluate the antitumor activity of TAS3351
timeFrame: estimated 20 months
measure: Dose Escalation: To evaluate the antitumor activity of TAS3351
timeFrame: estimated 20 months
measure: Dose Escalation: To evaluate the antitumor activity of TAS3351
timeFrame: estimated 20 months
measure: Dose Escalation: To characterize the pharmacokinetics (PK) of TAS3351
timeFrame: Cycle 1 Day 1 through cycle 1 Day 15 (21-Day cycle)
measure: Dose Escalation: To characterize the pharmacokinetics (PK) of TAS3351
timeFrame: ECycle 1 Day 1 through cycle 1 Day 15 (21-Day cycle)
measure: Dose Expansion: To confirm the safety and tolerability of TAS3351 at the recommended phase 2 dose and dosing schedule
timeFrame: estimated 9 months
measure: Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
timeFrame: estimated 9 months
measure: Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
timeFrame: estimated 9 months
measure: Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
timeFrame: estimated 9 months
measure: Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
timeFrame: estimated 9 months
measure: Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
timeFrame: estimated 9 months
measure: Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
timeFrame: estimated 9 months
measure: Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
timeFrame: estimated 9 months
measure: Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
timeFrame: estimated 9 months
measure: Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
timeFrame: estimated 9 months
measure: Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
timeFrame: estimated 9 months
measure: Phase 2: To evaluate the safety and tolerability of TAS3351
timeFrame: estimated 3 years
measure: Phase 2: To further assess the efficacy of TAS3351
timeFrame: estimated 3 years
measure: Phase 2: To further assess the efficacy of TAS3351
timeFrame: estimated 3 years
measure: Phase 2: To further assess the efficacy of TAS3351
timeFrame: estimated 3 years
measure: Phase 2: To further assess the efficacy of TAS3351
timeFrame: estimated 3 years
measure: Phase 2: To further assess the efficacy of TAS3351
timeFrame: estimated 3 years
measure: Phase 2: To further assess the efficacy of TAS3351
timeFrame: estimated 3 years
measure: Phase 2: To further assess the efficacy of TAS3351
timeFrame: estimated 3 years
measure: Phase 2: To further assess the efficacy of TAS3351
timeFrame: estimated 3 years
measure: Phase 2: To further assess the efficacy of TAS3351
timeFrame: estimated 3 years
measure: Phase 2: To further assess the efficacy of TAS3351
timeFrame: estimated 3 years
measure: Phase 2:To evaluate patient reported outcomes (PROs)
timeFrame: estimated 3 years
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University - Lombardi Comprehensive Cancer Center
state: District of Columbia
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
city: Houston
country: United States
facility: University of Texas M. D. Anderson Cancer Center
state: Texas
city: Fairfax
country: United States
facility: Next Oncology - Virginia
state: Virginia
city: Villejuif cedex
country: France
facility: Institut Gustave Roussy
state: Val De Marne
city: Koeln
country: Germany
facility: Universitaetsklinikum Koeln
state: Nordrhein Westfalen
city: Milano
country: Italy
facility: IEO Istituto Europeo di Oncologia
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East
state: Chiba-Ken
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center
state: Shizuoka-Ken
city: Koto-Ku
country: Japan
facility: Cancer Institute Hospital of JFCR
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seul
country: Korea, Republic of
facility: Asan Medical Center
city: Amsterdam
country: Netherlands
facility: Antoni van Leeuwenhoek
city: Leiden
country: Netherlands
facility: Leiden University Medical Center (LUMC)
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Manchester
country: United Kingdom
facility: The Christie Hospital
state: Greater Manchester
Study officials:
References: