MOLECULARLY TARGETED: Metastatic; Solid Tumors: HER2mt or ERBB4mt: SUMMIT

An open-label, multicenter, multinational, phase 2 study exploring the efficacy and safety of neratinib therapy in patients with solid tumors with activating HER2, HER3 or EGFR mutations or with EGFR gene amplification

Title
Puma NER-5201 (SUMMIT)
Study Title

An open-label, multicenter, multinational, phase 2 study exploring the efficacy and safety of neratinib therapy in patients with solid tumors with activating HER2, HER3 or EGFR mutations or with EGFR gene amplification

Site Link
Malignancy
Bladder, Breast, Lung, Colorectal, Brain (GBM), Head and Neck, Prostate, Kidney (Renal Cell), Rectal, Melanoma, Ovarian, Endometrial (Uterine), Cervical, Gastric, Pancreatic, Hepatocellular (HCC), Esophageal, lymphoma, sarcoma
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
Any (provided no curative therapy available)
Investigational Agent
Neratinib
Drug Class
pan-HER TKI
PI
Lee Schwartzberg, MD
Sponsor
Puma Biotechnologies
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Histologically confirmed cancer for which no curative therapy exists
  • Documented HER2 (ERBB2) or HER4 (ERBB4)  mutation in any malignancy or EGFR ex 18 mutations in lung cancer.
  • At least one measurable or evaluable lesion
  • LVEF >/=50%
  • ECOG PS 0-2
  • No prior treatment with ERBB2 (HER2) directed TKIs (eg lapatinib, afatinib, neratinib)
  • No symptomatic or unstable brain mets (stable are allowed)
  • No cumulative prior anthracycline dose >450mg/m2 doxorubicin or equivalent
  • No uncontrolled cardiac disease
  • No chronic diarrheal disorder
Objective

Primary- ORR at 8 weeks: Secondary- ORR, PFS, DoR, OS

Assessment Frequency
_
Assessment Frequency 2
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Assessment Frequency Link
Path
HER2 (ERBB2) mutation or HER4 (ERBB4 mutation), or EGFR ex. 18 mutated lung cancer
Dosing Frequency

Neratinib 240mg PO daily

Control Agents
N/A
Study Protocol
Randomized
No
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