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G1T48, an Oral SERD, Alone and in Combination With Palbociclib in ER-Positive, HER2-Negative Advanced Breast Cancer
Not Recruiting
Trial ID: NCT03455270
Purpose
This is a study to investigate the potential clinical benefit of G1T48 as an oral selective
estrogen receptor degrader (SERD) alone and in combination with palbociclib, a cyclin
dependent kinase 4/6 (CDK 4/6) inhibitor, in patients with estrogen receptor-positive,
HER2-negative metastatic breast cancer.
The study is an open-label design, consisting of 3 parts: dose-finding portion including food
effect (Part 1), G1T48 monotherapy expansion portion (Part 2), and G1T48 in combination with
palbociclib expansion portion (Part 3). All parts include 3 study phases: Screening Phase,
Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first
dose with study treatment and completes at the Post-Treatment Visit. Approximately, 184
patients may be enrolled in the study.
Official Title
A Phase 1, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Ascending Doses of G1T48 Alone and in Combination With Palbociclib in Women With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer
Stanford Investigator(s)
Mark Pegram
Susy Yuan-Huey Hung Professor
Eligibility
Inclusion Criteria:
- For Part 1, postmenopausal women only
- For Parts 2 and 3, any menopausal status
- Confirmed diagnosis of ER-positive, HER2-negative advanced breast cancer, not amenable
to curative therapy
- For Part 1, prior treatment with less than 4 prior lines of chemotherapy
- For Part 2, prior treatment with less than 2 prior line of chemotherapy
- For Part 3, prior treatment with no more than 1 prior line of chemotherapy
- For Parts 1 and 2, prior treatment with less than 4 prior endocrine therapies for
metastatic breast cancer
- For Part 3, prior treatment with no more than 1 prior line of endocrine therapies for
metastatic breast cancer
- For Parts 1 and 2, patients must satisfy 1 of the following criteria for prior
therapy:
- Progressed during treatment or within 12 months of completion of adjuvant therapy
with an aromatase inhibitor
- Progressed after the end of prior aromatase inhibitor therapy for
advanced/metastatic breast cancer
- For Part 3, patients must satisfy 1 of the following criteria for prior therapy:
- Received ≥ 24 months of endocrine therapy in the adjuvant setting prior to
recurrence or progression
- Received ≥ 6 months of endocrine therapy in the advanced/metastatic setting prior
to progression
- For Part 1, evaluable or measurable disease
- For Parts 2 and 3, evaluable (approximately 25%) or measurable disease (approximately
75%) as defined by RECIST, Version 1.1 including bone-only disease
- ECOG performance status 0 to 1
- Adequate organ function
Exclusion Criteria:
- For Part 3, prior treatment with CDK4/6 inhibitor, investigational oral SERDs or
SERCAs in any setting
- Active uncontrolled/symptomatic CNS metastases, carcinomatous meningitis, or
leptomeningeal disease
- Anticancer therapy within 14 days of first G1T48 dose or within 28 days for
antibody-based therapy
- Concurrent radiotherapy, radiotherapy within 14 days of first G1T48 dose, previous
radiotherapy to the target lesion sites, or prior radiotherapy to > 25% of bone marrow
- Prior hematopoietic stem cell or bone marrow transplantation
Intervention(s):
drug: G1T48
drug: Palbociclib
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Wyatt Forrest Gross
650-721-4076