West Cancer Center

ADVANCED SOLID TUMORS: Phase 1; TNBC/HER2+BC/NSCLC: "PCYC-1135-CA"

A multicenter study of the Bruton's tyrosine kinase (BTK) inhibitor, ibrutinib, in combination with MEDI4736, in subjects with relapsed or refractory solid tumors

Title

Pharmacyclics PCYC-1135-CA

Study Title

A multicenter study of the Bruton's tyrosine kinase (BTK) inhibitor, ibrutinib, in combination with MEDI4736, in subjects with relapsed or refractory solid tumors

Site Link

NCT02403271

Malignancy

z- Advanced Solid Tumors; Breast Cancer (HER2+ only) or lung cancer (squamous cell NCLC only)

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

>2nd line for NSCLC, >3rd line for breast

Investigational Agent

Ibrutinib and MEDI4736

Drug Class

Bruton's Tyrosine Kinase (BTK) Inihibitor (Ibrutinib), PD-L1 inhibitor (MEDI4736)

Jason Chandler, MD

Sponsor

Pharmacyclics

Phase

Phase 1

Status

Closed to Accrual

Key Eligibility Criteria

http://https://www.clinicaltrials.gov/ct2/show/NCT02403271

Key Eligibility Criteria Details

Either NSCLC (squamous only), Breast Cancer (HER2+ only)
Relapsed/refractory disease
One or more measurable disease lesions
ECOG PS 0-1Coags within 1.5x ULN
Creatinine within 2x ULN
No CNS involvement
No prior tx with BTK inhibitors (eg.ibrutinib), or immune tx (CTLA-4, PD-1, PD-L1).
No systemic steroids >10mg daily prednisone within last 14 days except as given as premed
No current or prior autoimmune disorders within 3 years
No other malignancies within 5 years
No known HBV/HCV/HIV

Objective

Primary (Phase 1)- Safety and Tolerability; Secondary (Phase 1); PK/PD. Primary (Phase 2): ORR; Secondary (Phase 2): AEs, PK.

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

TNBC or HER2+�breast cancerAdenocarcinoa or squamous carcinoma of lung

Dosing Frequency

Various

Control Agents

N/A

Study Protocol

Randomized