A Phase 1/2 Study of TAS3351 in Patients With Advanced Non-Small Cell Lung Cancer and EGFR Mutations
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Taiho Oncology, Inc.
- Enrollment
- 18
- Locations
- 17
- Primary Endpoint
- Dose Expansion: To explore the efficacy of TAS3351
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
TAS3351 Part A (Dose Escalation)
Dose escalation will assess the safety and determine the recommended phase 2 dose and regimen of TAS3351 administered orally.
Intervention: TAS3351 oral administration (Drug)
TAS3351 Part B (Dose Expansion)
TAS3351 in NSCLC patients with C797S EGFRmt. TAS3351 will be administered at the recommended phase 2 dose determined in Part A.
Intervention: TAS3351 oral administration (Drug)
TAS3351 Part C (Phase 2)
To assess efficacy of TAS3351 in NSCLC patients with C797S EGFRmt. TAS3351 will be administered at the recommended phase 2 dose.
Intervention: TAS3351 oral administration (Drug)
Outcomes
Primary Outcomes
Dose Expansion: To explore the efficacy of TAS3351
Time Frame: 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
Time Frame: baseline through cycle 1(each cycle is 21 days)
Incidence of dose limiting toxicities (DLTs)
Phase 2: To assess the efficacy of TAS3351
Time Frame: estimated 3 years
Objective Response Rate (ORR)
Secondary Outcomes
- Phase 2:To evaluate patient reported outcomes (PROs)(estimated 3 years)
- Dose Escalation: To characterize the pharmacokinetics (PK) of TAS3351(ECycle 1 Day 1 through cycle 1 Day 15 (21-Day cycle))
- Phase 2: To further assess the efficacy of TAS3351(estimated 3 years)
- Dose Escalation:To evaluate the antitumor activity of TAS3351(estimated 20 months)
- Dose Expansion: To further explore the anti-tumor efficacy of TAS3351(estimated 9 months)
- Dose Escalation: To evaluate the antitumor activity of TAS3351(estimated 20 months)
- Dose Expansion: To confirm the safety and tolerability of TAS3351 at the recommended phase 2 dose and dosing schedule(estimated 9 months)
- Phase 2: To evaluate the safety and tolerability of TAS3351(estimated 3 years)