West Cancer Center

MOLECULARLY TARGETED: PTEN loss/LOF: myTACTIC Arm D(1)

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 D: Ipatasertib in patients with PTEN Loss/Loss-of-function or AKT activating mutation-positive tumors

Title

Genentech ML42439 (myTACTIC) PTEN

Study Title

Site Link

NCT04632992

Malignancy

Any: Lung, 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

Any line

Investigational Agent

Ipatasertib

Drug Class

AKT inhibitor

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
Either PTEN protein loss as determined by a CLIA or equivalently certified immunohistochemistry assay OR
PTEN loss of function defined as PTEN dominant negative missense mutations or deleterious in-frame and missense mutations affecting protein function
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
No insuline dependent diabetes

Objective

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

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

PTEN loss or loss of function

Dosing Frequency

Control Agents

Study Protocol

Randomized