A Phase I Study of RGT-419B in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer or Other Solid Tumors

Regor Pharmaceuticals

Status and phase: Active, not recruiting; Phase 1

Conditions: Breast Cancer; Advanced Solid Tumor

Treatments: Drug: RGT-419B

Study type: Interventional

Funder types: Industry

Identifiers

NCT06299124

RGT-419B-102

Details and patient eligibility

About

This is a Phase 1 dose escalation and dose expansion phase I study to evaluate the safety, tolerability, pharmacokinetic profile and preliminary efficacy of RGT-419B as monotherapy in Chinese patients with HR+/HER2- advanced/metastatic breast cancer and other advanced solid tumors.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female ≥ 18 years of age
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
• Subjects with pathologically confirmed advanced solid tumors who have failed standard-of-care therapy, or have no standard-of-care therapy available, or are currently not eligible for standard-of-care therapy; Subjects with HR+/ HER2- advanced or metastatic breast cancer are preferred.
• Estimated life expectancy of at least 12 weeks

Exclusion criteria

• Presence of visceral metastases with severe organ dysfunction
• Known active hepatitis B or C infection
• Prior irradiation to >25% of the bone marrow and/or inadequate bone marrow function or evidence of clinicallysignificant end-organ damage
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to the drugs usedin the study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

RGT-419B monotherapy

Experimental group

Description:

Dose escalation and dose expansion of RGT-419B monotherapy

Treatment:

Drug: RGT-419B