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JOURNAL ONKOLOGIE – STUDIE
TAS3351

A Study of TAS3351 in NSCLC Patients With EGFRmt

Rekrutierend

NCT-Nummer:
NCT05765734

Studienbeginn:
Mai 2023

Letztes Update:
21.11.2023

Wirkstoff:
TAS3351 oral administration

Indikation (Clinical Trials):
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Taiho Oncology, Inc.

Collaborator:
-

Kontakt

Studienlocations
(3 von 17)

Georgetown University - Lombardi Comprehensive Cancer Center
20007 Washington
United StatesNoch nicht rekrutierend» Google-Maps
Ansprechpartner:

Phone: 202-444-4000
E-Mail: chul.kim@gunet.georgetown.edu» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. 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)):
Adverse Events

2. 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)

3. Dose Expansion: To explore the efficacy of TAS3351 (Time Frame - estimated 9 months):
Objective Response Rate (ORR)

4. Phase 2: To assess the efficacy of TAS3351 (Time Frame - estimated 3 years):
Objective Response Rate (ORR)

Secondary outcome:

1. Dose Escalation:To evaluate the antitumor activity of TAS3351 (Time Frame - estimated 20 months):
Objective response rate (ORR)

2. Dose Escalation:To evaluate the antitumor activity of TAS3351 (Time Frame - estimated 20 months):
Duration of response (DoR)

3. Dose Escalation:To evaluate the antitumor activity of TAS3351 (Time Frame - estimated 20 months):
Disease control rate (DCR)

4. Dose Escalation: To evaluate the antitumor activity of TAS3351 (Time Frame - estimated 20 months):
Progression free survival (PFS)

5. Dose Escalation: To evaluate the antitumor activity of TAS3351 (Time Frame - estimated 20 months):
Overall Survival (OS)

6. Dose Escalation: To characterize the pharmacokinetics (PK) of TAS3351 (Time Frame - Cycle 1 Day 1 through cycle 1 Day 15 (21-Day cycle)):
Evaluate the maximum plasma concentration (Cmax)

7. Dose Escalation: To characterize the pharmacokinetics (PK) of TAS3351 (Time Frame - ECycle 1 Day 1 through cycle 1 Day 15 (21-Day cycle)):
Area under the plasma concentration-time curve (AUC)

8. Dose Expansion: To confirm the safety and tolerability of TAS3351 at the recommended phase 2 dose and dosing schedule (Time Frame - estimated 9 months):
Adverse Events (AEs)

9. Dose Expansion: To further explore the anti-tumor efficacy of TAS3351 (Time Frame - estimated 9 months):
Duration of response (DoR) by ICR

10. Dose Expansion: To further explore the anti-tumor efficacy of TAS3351 (Time Frame - estimated 9 months):
Progression Free Survival (PFS) by ICR

11. Dose Expansion: To further explore the anti-tumor efficacy of TAS3351 (Time Frame - estimated 9 months):
Disease Control Rate (DCR) by ICR

12. Dose Expansion: To further explore the anti-tumor efficacy of TAS3351 (Time Frame - estimated 9 months):
Objective Response Rate (ORR) by Investigator Assessment

13. Dose Expansion: To further explore the anti-tumor efficacy of TAS3351 (Time Frame - estimated 9 months):
Duration of Response (DoR) by Investigator Assessment

14. Dose Expansion: To further explore the anti-tumor efficacy of TAS3351 (Time Frame - estimated 9 months):
Progression Free Survival (PFS) by Investigator Assessment

15. Dose Expansion: To further explore the anti-tumor efficacy of TAS3351 (Time Frame - estimated 9 months):
Disease Control Rate (DCR) by Investigator Assessment

16. Dose Expansion: To further explore the anti-tumor efficacy of TAS3351 (Time Frame - estimated 9 months):
Intracranial Objective Response Rate (icORR)

17. Dose Expansion: To further explore the anti-tumor efficacy of TAS3351 (Time Frame - estimated 9 months):
Intracranial Duration of Response (icDOR)

18. Dose Expansion: To further explore the anti-tumor efficacy of TAS3351 (Time Frame - estimated 9 months):
Overall survival (OS)

19. Phase 2: To evaluate the safety and tolerability of TAS3351 (Time Frame - estimated 3 years):
Adverse Events (AEs)

20. Phase 2: To further assess the efficacy of TAS3351 (Time Frame - estimated 3 years):
Duration of response (DoR) by ICR

21. Phase 2: To further assess the efficacy of TAS3351 (Time Frame - estimated 3 years):
Progression Free Survival (PFS) by ICR

22. Phase 2: To further assess the efficacy of TAS3351 (Time Frame - estimated 3 years):
Disease Control Rate (DCR) by ICR

23. Phase 2: To further assess the efficacy of TAS3351 (Time Frame - estimated 3 years):
Objective Response Rate (ORR) by Investigator Assessment

24. Phase 2: To further assess the efficacy of TAS3351 (Time Frame - estimated 3 years):
Duration of Response (DoR) by Investigator Assessment

25. Phase 2: To further assess the efficacy of TAS3351 (Time Frame - estimated 3 years):
Progression Free Survival (PFS) by Investigator Assessment

26. Phase 2: To further assess the efficacy of TAS3351 (Time Frame - estimated 3 years):
Disease Control Rate (DCR) by Investigator Assessment

27. Phase 2: To further assess the efficacy of TAS3351 (Time Frame - estimated 3 years):
Intracranial Objective Response Rate (icORR)

28. Phase 2: To further assess the efficacy of TAS3351 (Time Frame - estimated 3 years):
Intracranial Duration of Response (icDOR)

29. Phase 2: To further assess the efficacy of TAS3351 (Time Frame - estimated 3 years):
Overall survival (OS)

30. Phase 2:To evaluate patient reported outcomes (PROs) (Time Frame - estimated 3 years):
responses to patient questionnaires

Studien-Arme

  • 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.

Geprüfte Regime

  • TAS3351 oral administration:
    TAS3351 will be administered orally

Quelle: ClinicalTrials.gov


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