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

NCT06299124 | Active Not Recruiting Phase 1

• 1 other identifier: RGT-419B-102
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Advanced Solid Tumor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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 pharmacokinetics(PK) assessment of RGT-419B and major metabolites - Cmax

  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)

  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)

Study Arms (1)

RGT-419B monotherapy

EXPERIMENTAL

Dose escalation and dose expansion of RGT-419B monotherapy

Drug: RGT-419B

Interventions

RGT-419B DRUG

RGT-419B will be administered orally

Also known as: Active drug

RGT-419B monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regor Pharmaceuticals Inc.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Bulk Drugs

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

• Jian Zhang, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 7, 2024
• Study Start: April 17, 2023
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)