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First-in-Human Study of RGT-419B Alone and With Endocrine Therapy in Subjects With HR-Positive, HER2-Negative Advanced/Metastatic Breast Cancer

Status
Active
Cancer Type
Breast Cancer
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT05304962
Protocol IDs
RGT-419B_01-101 (primary)
NCI-2022-03843
Study Sponsor
Regor Pharmaceuticals Inc.

Summary

This is a phase I, First-in-Human (FIH), open-label study to evaluate the safety,
tolerability, pharmacokinetic (PK) profile, and preliminary efficacy of RGT-419B administered
orally as monotherapy OR in combination with Hormonal Therapy in subjects with HR+, HER2-
locally advanced and unresectable (Stage III) or metastatic (Stage IV) breast cancer whose
disease has progressed during prior therapy with an approved CDK4/6i plus hormonal therapy.

Eligibility

  1. Male or female >/= 18 years old
  2. ECOG Performance Status 0 to 1
  3. HR+, HER2- tumor by most recent biopsy with measurable disease
  4. Have had no more than 1 prior line of cytotoxic chemotherapy in the ABC setting AND no serious/severe toxicity to a prior CKD4/6i AND no known contraindication to receiving RT-419B AND have had all acute/residual toxic effects of any prior therapy
  5. In the ABC setting, eligible subjects must have failed to respond to or progressed after <3 lines of prior CDK4/6i therapy and unlimited lines of prior HT and have had no more than 1 prior line of chemotherapy. Eligible subjects must have received and progressed on any combination of HTs including any approved AI, SERD, or SERM, and/or any approved CDK4/6i in any order. (5a) For subjects in Arm B, at least one line of prior therapy must have included a locally approved HT which was well tolerated and which the subject is willing to receive again (5b) Subjects with tumors harboring a PIK3CA mutation will be allowed to enroll, and treatment with a PI3Ki in combination with HT will be allowed as a prior line of therapy. Surgical excision of tumor tissue accompanied by chemotherapy or targeted therapy is also counted as 1 line of prior treatment.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.