West Cancer Center

MOLECULARLY TARGETED: ROS1 fusion: myTACTIC Arm A

myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression pattersn predictive of response: Arm A: Entrectinib in patients with ROS1 fusion-positive tumors

Title

Genentech ML42439 (myTACTIC) ROS1

Study Title

Site Link

NCT04632992

Malignancy

Breast, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

Ideally 1st line, but can be later line as well

Investigational Agent

Entrectinib

Drug Class

TKI against NTRK, ROS, and ALK

Sponsor

Genentech, Inc.

Phase

Phase 2

Status

Closed to Accrual

Key Eligibility Criteria

Key Eligibility Criteria Details

Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
Positive biomarker results from a CLIA certified lab, either tissue or blood sample
ROS1 gene fusion positivity
No non-small lung cancer (NSCLC)
ECOG PS 0-2
No symptomatic CNS metastases
No known HIV/HBV/HCV
No other malignancy within 3 years of study
No prior treatment with crizotinib

Objective

Primary-
- ORR
Secondary
- PFS
- DoR
- OS
- PFS at various time points
- DCR
- Safety

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

ROS1 fusion. Any cancer type except not NSCLC

Dosing Frequency

Control Agents

Study Protocol

Randomized