West Cancer Center

BREAST: METASTATIC: Triple Negative: 1st line or >2nd Line: “CX-839-007”

A multicenter phase 2 study of the glutaminase inhibitor CB-839 in combination with paclitaxel in patients with advanced triple negative breast cancer (TNBC) including patients of African ancestry and non-African ancestry

Title

Calithera CX-839-007

Study Title

Site Link

NCT03057600

Malignancy

Breast, Metastatic Breast Cancer, Triple Negative Breast Cancer, TNBC

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

Cohorts 2 and 4- 1st line; Cohorts 1 and 3- 3rd line or higher

Investigational Agent

CB-839

Drug Class

Glutaminase Inhibitor

Greg Vidal, MD

Sponsor

Calithera Biosciences, Inc.

Phase

Phase 2

Status

Closed to Accrual

Key Eligibility Criteria

NCT03057600

Key Eligibility Criteria Details

Females >18 years old
TNBC defined as ER/PR <1%, HER2 negative
ECOG PS 0-1
Labs within standard limits
No known CNS disease unless adequately treated with XRT or surgery and stable by symptoms for at least 2 months prior
No other malignancy within 3 years (except non-melanoma skin cancer or in situ cancers)
No unstable cardiac disease
No known sensitivity Cremaphor
Cohort 1- 3rd+ line in African ancestry
- Must have received prior taxane for metastatic disease but not in most recent treatment
- Adjuvant therapy counts as therapy if time to recurrence <12 months
Cohort 2- 1st line in African ancestry- no prior systemic tx for advanced disease
- Adjuvant therapy only allowd if time to recurrence >12 mo
Cohort 3- 3rd+ line in non-African ancestry
- Similar to Cohort 1
Cohort 4- 1st line in non-African ancestry
- Similar to cohort 2

Objective

Primary- ORR; Secondary-PFS, OS, DoR, CBR

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Triple negative

Dosing Frequency

CB-839 given bid in 28 day cycles, paclitaxel as per standard

Control Agents

N/A

Study Protocol

Randomized