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PF-06804103 Dose Escalation in HER2 Positive and Negative (Negative Only in Part 2) Solid Tumors

About

Brief Summary

This is a Phase 1, open-label, multi-center, multiple-dose, safety, Pharmacokinetic [absorption, distribution, metabolism, and excretion (PK)] and pharmacodynamic [effects of study drug on the body (PD)] trial of study drug PF-06804103 in sequential groups of adult patients with Human Epidermal Growth Factor Receptor-positive (HER2+) solid tumors. This study contains two parts, increasing dose segment by groups (Part 1) followed by an expansion segment where greater numbers of patients are given the same dose (Part 2). Sequential groups of patients with HER2-positive breast cancer (BC) or HER2+ gastric cancer (GC) will receive escalating doses of PF-06804103 in Part 1 of the study. Part 2 will further evaluate the dose selected from Part 1 in patients with HER2-positive breast cancer, HER2 low-expressing breast cancer, HER2-positive gastric cancer, and HER2-positive non-small cell lung cancer. Enrollment of patients with HER2-positive NSCLC will not be initiated in Part 2 if significant negative effects on the lungs is observed in Part 1. Approximately 95 patients are expected to be enrolled in the study overall. The actual number of patients enrolled will depend on how well patients tolerate PF-06804103 and the number of dose levels required to identify the maximum tolerated dose (MTD). Study Treatments PF-06804103 will be administered as an intravenous (IV) infusion every 21 days with a starting dose of 0.15 mg/kg. Based on emerging clinical and PK data, an alternate dosing schedule may also be evaluated. Treatment with the study drug PF-06804103 will continue until either disease progression, patient refusal, or unacceptable side effects occurs, whichever occurs first, unless the investigator and medical monitor agree to treatment beyond progression based on individual benefit/risk assessments.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase I

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Adult subjects diagnosed with solid tumors that exhibit a variation called HER2 positive. For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Inclusion Criteria:

  • HER2 positive breast cancer or gastric cancer that is resistant to standard therapy or for which no standard therapy is available (Part 1A only)
  • HER2 positive and negative breast cancer (Part 2A)
  • HER2 negative breast cancer (Part 1B & Part 2B)
  • Performance status of 0 or 1
  • Adequate bone marrow, kidney and liver function

Exclusion Criteria:

  • Known CNS disease including, but not limited to, metastases
  • History of exposure to certain cumulative doses of anthracyclines
  • Grade 3 or higher hypersensitivity reaction to prior receipt of any antibody therapy
  • Active and clinically significant bacterial, fungal, or viral infection
  • Abnormal cardiac function defined by a LVEF <50% by ECHO or MUGA
  • Patients with previous history or active interstitial lung disease or pulmonary fibrosis, or a history of other clinically significant lung diseases

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Study Stats
Protocol No.
17-001086
Category
Hematology-Oncology
Oncology
Contact
CHRISTOPHER LIM
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT03284723
For detailed technical eligibility, visit ClinicalTrials.gov.