A Study of TAS2940 in Participants With Locally Advanced or Metastatic Solid Tumor Cancer

• Sponsor: Taiho Oncology, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04982926
• Collaborator: (none)
• Enrollment: 42
• Locations: 3
• Arms: 5
• Anticipated Duration (Months): 44.5
• Patients Per Site: 14
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This is a first-in-human, open label, multicenter study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and the preliminary antitumor activity of TAS2940 in patients with advanced or metastatic solid tumors who are not candidates for approved or available therapies.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor; Glioblastoma; Non-small Cell Lung Cancer; Breast Cancer	Drug: TAS2940; Drug: TAS2940	Phase 1

Detailed Description

TAS2940 is a small molecule inhibitor of ERBB family proteins HER2 and EGFR. It has not been evaluated in human subjects yet. The study will be conducted in 2 parts, dose escalation and dose expansion. The dose escalation part will assess the safety and determine the maximum tolerated dose, the recommended phase 2 dose and the recommended dosing regimen of TAS2940 administered orally. The dose expansion part will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 42 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1 Study of TAS2940 in Patients With Locally Advanced or Metastatic Solid Tumors With EGFR and / or HER2 Aberrations
• Actual Study Start Date: Sep 16, 2021
• Anticipated Primary Completion Date: May 1, 2025
• Anticipated Study Completion Date: Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TAS2940 Dose Escalation Dose escalation will assess the safety and determine the maximum tolerated dose, the recommended phase 2 dose and the recommended dosing regimen of TAS2940 administered orally.	Drug: TAS2940; Study participants with solid tumors and EGFR or HER2 aberrations will receive TAS2940 tablets daily at increasing doses until MTD is reached.
Experimental: Dose Expansion Non-small Cell Lung Cancer Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations	Drug: TAS2940; Study subjects with select solid tumors characterized by EGFR or HER2 aberrations will receive TAS2940 at the dose identified during Dose Escalation phase.
Experimental: Dose Expansion Breast Cancer Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations	Drug: TAS2940; Study subjects with select solid tumors characterized by EGFR or HER2 aberrations will receive TAS2940 at the dose identified during Dose Escalation phase.
Experimental: Dose Expansion Gliblastoma Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations.	Drug: TAS2940; Study subjects with select solid tumors characterized by EGFR or HER2 aberrations will receive TAS2940 at the dose identified during Dose Escalation phase.
Experimental: Dose Expansion Solid tumors Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations.	Drug: TAS2940; Study subjects with select solid tumors characterized by EGFR or HER2 aberrations will receive TAS2940 at the dose identified during Dose Escalation phase.

Outcome Measures

Primary Outcome Measures

1. Dose Escalation:Maximum Tolerated Dose (MTD) [One Month]

   Determine the incidence of dose-liming toxicities (DLTs) and adverse events (AEs) graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 within the first cycle

2. Dose Expansion:Overall Response Rate [6 Months]

   Document the ORR, defined as proportion of patients experiencing a best overall response of Complete Response (CR) or Partial response (PR) based on investigator accessed radiographic response per RECIST 1.1 or RANO criteria

Secondary Outcome Measures

1. Dose Escalation: Overall Response Rate (ORR) [6 Months]

   Document the ORR defined as proportion of patients experiencing a best overall response of Complete Response (CR) or Partial response (PR) based on investigator accessed radiographic response per RECIST 1.1 or RANO criteria

2. Dose Escalation:Pharmacokinetic (PK) Profile [3 Months]

   Evaluation of the maximum observed plasma concentration; time to reach maximum concentration, area under the Concentration-time curve and time it takes for plasma concentration to fall by half its original value (T1/2) of TAS2940

3. Dose Expansion:Incidence of treatment-emergent Adverse Events (Safety and tolerability) [Estimated up to 6 months]

   Safety and tolerability of TAS2940 based on reported AEs, graded according to NCI-CTCAE v.5.0

4. Dose Expansion:Duration of Response (DOR) [Estimated up to 6 months]

   DOR, defined as time from the first documentation of response to date of objective tumor progression or death due to any cause, whichever occurs first.

5. Dose Expansion:Disease Control Rate (DCR) [Estimated up to 6 months]

   DCR, defined as the proportion of patients experiencing a best overall response of Stable Disease (SD), PR or CR

6. Dose Expansion:Progression Free Survival (PFS) [Estimated up to 6 months]

   Date of PR or CR to date of objective progression or death due to any cause.

7. Dose Expansion:Pharmacokinetic profile of TAS2940 [3 Months]

   Evaluation of the maximum observed plasma concentration; time to reach maximum concentration, area under the Concentration-time curve and time it takes for plasma concentration to fall by half its original value (T1/2) of TAS2940

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Have histologically confirmed solid cancer that is locally advanced and metastatic and available standard treatment options have been exhausted

• Have adequate organ function

• ECOG PS 0-1

Dose Escalation:

• Have measurable or non- measurable disease per RECIST criteria v1.1 or RANO

• Any solid tumor with EGFR and / or HER2 aberration

Dose Expansion:

• Have measurable disease per RECIST criteria v1.1 for solid tumor (excluding primary brain tumor) or RANO (for glioblastoma)

• Cohort A: Non-small cell lung cancer (NSCLC)

• Cohort B: HER2 positive breast cancer

• Cohort C: Recurrent or refractory glioblastoma

• Cohort D: Other solid tumors with EGFR or HER2 aberrations

Exclusion Criteria:

• Non-stable brain metastases

• Have significant cardiovascular disorder

• Have not recovered from prior cancer treatment

• A serious illness or medical condition

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tennessee Oncology	Nashville	Tennessee	United States	37203
2	University of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030
3	CLCC Gustave Roussy	Villejuif	Cedex	France	94805

Sponsors and Collaborators

• Taiho Oncology, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Taiho Oncology, Inc.
• ClinicalTrials.gov Identifier: NCT04982926
• Other Study ID Numbers: TAS2940-101; 2021-002189-41
• First Posted: Jul 29, 2021
• Last Update Posted: Mar 2, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Glioblastoma

Study Results

No Results Posted as of Mar 2, 2022