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

Phase 1Active Not RecruitingNCT06299124

Regor Pharmaceuticals Inc.40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer Advanced Solid Tumor

Interventions

RGT-419BDRUG

RGT-419B will be administered orally

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Safety & Tolerability - Number of subjects with Dose-Limiting Toxicities (DLTs) at each cohort dose level

Number of subjects who have a confirmed DLT at each cohort dose level during the first 28-day cycle of RGT-419B treatment.

Time frame: 4 weeks (1 cycle)

Secondary Outcomes

Safety & Tolerability - Incidence, Severity, and Causality of all Treatment Emergent Adverse Events (TEAEs)

Incidence, severity, and causality of all TEAEs will be assessed for all patients participating from Day 1 dosing through end of study.

Time frame: through study completion, an average of 1 year

Day 1 and steady-state pharmacokinetics(PK) assessment of RGT-419B and major metabolites - Cmax

Time frame: 4 weeks (1 cycle)

Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Area Under Concentration-TimeCurve to Infinity (AUC0-inf)

Time frame: 4 weeks (1 cycle)

Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Plasma Decay Half-Life (t1/2)

Time frame: 4 weeks (1 cycle)

Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Time to Reach Maximum ObservedPlasma Concentration (Tmax)

Time frame: 4 weeks (1 cycle)

Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Accumulation rate after multipledoses

Time frame: 4 weeks (1 cycle)

Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Cumulative urinary excretion

Data from ClinicalTrials.gov

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