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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05765734




Registration number
NCT05765734
Ethics application status
Date submitted
8/02/2023
Date registered
13/03/2023

Titles & IDs
Public title
A Study of TAS3351 in NSCLC Patients With EGFRmt
Scientific title
A Phase 1/2 Study of TAS3351 in Patients With Advanced Non-Small Cell Lung Cancer and EGFR Mutations
Secondary ID [1] 0 0
2022-502595-23
Secondary ID [2] 0 0
10073010
Universal Trial Number (UTN)
Trial acronym
TAS3351
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TAS3351 oral administration

Experimental: TAS3351 Part A (Dose Escalation) - Dose escalation will assess the safety and determine the recommended phase 2 dose and regimen of TAS3351 administered orally.

Experimental: 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.

Experimental: 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.


Treatment: Drugs: TAS3351 oral administration
TAS3351 will be administered orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose Escalation: To investigate the safety and determine the recommended Phase 2 dose and dosing schedule of TAS3351
Timepoint [1] 0 0
baseline through cycle 1(each cycle is 21 days)
Primary outcome [2] 0 0
Dose Escalation: To investigate the safety and determine the recommended Phase 2 dose and dosing schedule of TAS3351
Timepoint [2] 0 0
baseline through cycle 1(each cycle is 21 days)
Primary outcome [3] 0 0
Dose Expansion: To explore the efficacy of TAS3351
Timepoint [3] 0 0
estimated 9 months
Primary outcome [4] 0 0
Phase 2: To assess the efficacy of TAS3351
Timepoint [4] 0 0
estimated 3 years
Secondary outcome [1] 0 0
Dose Escalation:To evaluate the antitumor activity of TAS3351
Timepoint [1] 0 0
estimated 20 months
Secondary outcome [2] 0 0
Dose Escalation:To evaluate the antitumor activity of TAS3351
Timepoint [2] 0 0
estimated 20 months
Secondary outcome [3] 0 0
Dose Escalation:To evaluate the antitumor activity of TAS3351
Timepoint [3] 0 0
estimated 20 months
Secondary outcome [4] 0 0
Dose Escalation: To evaluate the antitumor activity of TAS3351
Timepoint [4] 0 0
estimated 20 months
Secondary outcome [5] 0 0
Dose Escalation: To evaluate the antitumor activity of TAS3351
Timepoint [5] 0 0
estimated 20 months
Secondary outcome [6] 0 0
Dose Escalation: To characterize the pharmacokinetics (PK) of TAS3351
Timepoint [6] 0 0
Cycle 1 Day 1 through cycle 1 Day 15 (21-Day cycle)
Secondary outcome [7] 0 0
Dose Escalation: To characterize the pharmacokinetics (PK) of TAS3351
Timepoint [7] 0 0
ECycle 1 Day 1 through cycle 1 Day 15 (21-Day cycle)
Secondary outcome [8] 0 0
Dose Expansion: To confirm the safety and tolerability of TAS3351 at the recommended phase 2 dose and dosing schedule
Timepoint [8] 0 0
estimated 9 months
Secondary outcome [9] 0 0
Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
Timepoint [9] 0 0
estimated 9 months
Secondary outcome [10] 0 0
Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
Timepoint [10] 0 0
estimated 9 months
Secondary outcome [11] 0 0
Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
Timepoint [11] 0 0
estimated 9 months
Secondary outcome [12] 0 0
Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
Timepoint [12] 0 0
estimated 9 months
Secondary outcome [13] 0 0
Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
Timepoint [13] 0 0
estimated 9 months
Secondary outcome [14] 0 0
Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
Timepoint [14] 0 0
estimated 9 months
Secondary outcome [15] 0 0
Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
Timepoint [15] 0 0
estimated 9 months
Secondary outcome [16] 0 0
Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
Timepoint [16] 0 0
estimated 9 months
Secondary outcome [17] 0 0
Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
Timepoint [17] 0 0
estimated 9 months
Secondary outcome [18] 0 0
Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
Timepoint [18] 0 0
estimated 9 months
Secondary outcome [19] 0 0
Phase 2: To evaluate the safety and tolerability of TAS3351
Timepoint [19] 0 0
estimated 3 years
Secondary outcome [20] 0 0
Phase 2: To further assess the efficacy of TAS3351
Timepoint [20] 0 0
estimated 3 years
Secondary outcome [21] 0 0
Phase 2: To further assess the efficacy of TAS3351
Timepoint [21] 0 0
estimated 3 years
Secondary outcome [22] 0 0
Phase 2: To further assess the efficacy of TAS3351
Timepoint [22] 0 0
estimated 3 years
Secondary outcome [23] 0 0
Phase 2: To further assess the efficacy of TAS3351
Timepoint [23] 0 0
estimated 3 years
Secondary outcome [24] 0 0
Phase 2: To further assess the efficacy of TAS3351
Timepoint [24] 0 0
estimated 3 years
Secondary outcome [25] 0 0
Phase 2: To further assess the efficacy of TAS3351
Timepoint [25] 0 0
estimated 3 years
Secondary outcome [26] 0 0
Phase 2: To further assess the efficacy of TAS3351
Timepoint [26] 0 0
estimated 3 years
Secondary outcome [27] 0 0
Phase 2: To further assess the efficacy of TAS3351
Timepoint [27] 0 0
estimated 3 years
Secondary outcome [28] 0 0
Phase 2: To further assess the efficacy of TAS3351
Timepoint [28] 0 0
estimated 3 years
Secondary outcome [29] 0 0
Phase 2: To further assess the efficacy of TAS3351
Timepoint [29] 0 0
estimated 3 years
Secondary outcome [30] 0 0
Phase 2:To evaluate patient reported outcomes (PROs)
Timepoint [30] 0 0
estimated 3 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2027
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
District of Columbia
Country [2] 0 0
United States of America
State/province [2] 0 0
Tennessee
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
United States of America
State/province [4] 0 0
Virginia
Country [5] 0 0
France
State/province [5] 0 0
Val De Marne
Country [6] 0 0
Germany
State/province [6] 0 0
Nordrhein Westfalen
Country [7] 0 0
Italy
State/province [7] 0 0
Milano
Country [8] 0 0
Japan
State/province [8] 0 0
Chiba-Ken
Country [9] 0 0
Japan
State/province [9] 0 0
Shizuoka-Ken
Country [10] 0 0
Japan
State/province [10] 0 0
Koto-Ku
Country [11] 0 0
Korea, Republic of
State/province [11] 0 0
Seoul
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Seul
Country [13] 0 0
Netherlands
State/province [13] 0 0
Amsterdam
Country [14] 0 0
Netherlands
State/province [14] 0 0
Leiden
Country [15] 0 0
Spain
State/province [15] 0 0
Barcelona
Country [16] 0 0
Spain
State/province [16] 0 0
Madrid
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Greater Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Taiho Oncology, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Taiho Oncology, Inc
Address 0 0
Country 0 0
Phone 0 0
+1 844-878-2446
Fax 0 0
Email 0 0
medicalinformation@taihooncology.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05765734