Clinical trial NCT04982926: A Study of TAS2940 in Participants With Locally Advanced or Metastatic Solid Tumor Cancer
Official title: A Phase 1 Study of TAS2940 in Patients With Locally Advanced or Metastatic Solid Tumors With EGFR and / or HER2 Aberrations
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Solid Tumor
Glioblastoma
Non-small Cell Lung Cancer
Breast Cancer
Lead sponsor: Taiho Oncology, Inc.
Sponsor class: INDUSTRY
First posted: 2021-07-29
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Dose Escalation:Maximum Tolerated Dose (MTD)
timeFrame: One Month
measure: Dose Expansion:Overall Response Rate
timeFrame: 6 Months
Secondary outcomes:
measure: Dose Escalation: Overall Response Rate (ORR)
timeFrame: 6 Months
measure: Dose Escalation:Pharmacokinetic (PK) Profile
timeFrame: 3 Months
measure: Dose Expansion:Incidence of treatment-emergent Adverse Events (Safety and tolerability)
timeFrame: Estimated up to 6 months
measure: Dose Expansion:Duration of Response (DOR)
timeFrame: Estimated up to 6 months
measure: Dose Expansion:Disease Control Rate (DCR)
timeFrame: Estimated up to 6 months
measure: Dose Expansion:Progression Free Survival (PFS)
timeFrame: Estimated up to 6 months
measure: Dose Expansion:Pharmacokinetic profile of TAS2940
timeFrame: 3 Months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Villejuif
country: France
facility: CLCC Gustave Roussy
state: Cedex
Study officials:
References: