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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06299124
• Other study ID #: RGT-419B-102
• Status: Recruiting
• Phase: Phase 1
• Start date: April 17, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: March 2024
• Source: Regor Pharmaceuticals Inc.
• Contact: Yan Zhou
• Phone: 86-021-31168233
• Email: yan.zhou[@]qlregor.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• RGT-419B
RGT-419B will be administered orally

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Regor Pharmaceuticals Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks (1 cycle)
Secondary	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.	through study completion, an average of 1 year
Secondary	Day 1 and steady-state pharmacokinetics(PK) assessment of RGT-419B and major metabolites - Cmax		4 weeks (1 cycle)
Secondary	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)
Secondary	Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Plasma Decay Half-Life (t1/2)		4 weeks (1 cycle)
Secondary	Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Time to Reach Maximum ObservedPlasma Concentration (Tmax)		4 weeks (1 cycle)
Secondary	Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Accumulation rate after multipledoses		4 weeks (1 cycle)
Secondary	Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Cumulative urinary excretion		4 weeks (1 cycle)
Secondary	Tumor Response assessed by Investigator according to RECIST v1.1		through study completion, an average of 1 year
Secondary	QTc Interval - Changes in corrected QT interval	Number of subjects with a clinically significant increase from baseline in corrected QT (QTc) interval onrepeated ECGs	through study completion, an average of 1 year