A Study of TAS3351 in NSCLC Patients With EGFRmt
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 18
- 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
- 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
Scroll for more (7 remaining)Georgetown University - Lombardi Comprehensive Cancer Center🇺🇸Washington, District of Columbia, United States