A Phase I Study Evaluating Safety and Tolerability of RGT-419B Monotherapy in Chinese Patients With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Advanced/Metastatic Breast Cancer or Other Solid Tumors

Regor Pharmaceuticals Inc.1 site in 1 country40 target enrollmentApril 17, 2023

ConditionsBreast Cancer Advanced Solid Tumor

InterventionsRGT-419B

DrugsRGT-419B

Overview

Phase: Phase 1
Intervention: RGT-419B
Conditions: Breast Cancer
Sponsor: Regor Pharmaceuticals Inc.
Enrollment: 40
Locations: 1
Primary Endpoint: Safety & Tolerability - Number of subjects with Dose-Limiting Toxicities (DLTs) at each cohort dose level
Status: Active, Not Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 17, 2023

End Date

July 30, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Regor Pharmaceuticals Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

RGT-419B monotherapy

Dose escalation and dose expansion of RGT-419B monotherapy

Intervention: RGT-419B

Outcomes

Primary Outcomes

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

Time Frame: 4 weeks (1 cycle)

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

Secondary Outcomes

Day 1 and steady-state pharmacokinetics(PK) assessment of RGT-419B and major metabolites - Cmax(4 weeks (1 cycle))
Safety & Tolerability - Incidence, Severity, and Causality of all Treatment Emergent Adverse Events (TEAEs)(through study completion, an average of 1 year)
Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Area Under Concentration-TimeCurve to Infinity (AUC0-inf)(4 weeks (1 cycle))
Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Accumulation rate after multipledoses(4 weeks (1 cycle))
Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Plasma Decay Half-Life (t1/2)(4 weeks (1 cycle))
Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Time to Reach Maximum ObservedPlasma Concentration (Tmax)(4 weeks (1 cycle))
Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Cumulative urinary excretion(4 weeks (1 cycle))
Tumor Response assessed by Investigator according to RECIST v1.1(through study completion, an average of 1 year)
QTc Interval - Changes in corrected QT interval(through study completion, an average of 1 year)