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NCT Number: NCT06299124

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Advanced Solid Tumor Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RGT-419B

Drug

RGT-419B will be administered orally

Other names: Active drug

Primary outcomes

  1. 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

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

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

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

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

    Time frame: 4 weeks (1 cycle)

  3. 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)

  4. 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)

  5. 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)

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

    Time frame: 4 weeks (1 cycle)

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

    Time frame: 4 weeks (1 cycle)

  8. Tumor Response assessed by Investigator according to RECIST v1.1

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

  9. QTc Interval - Changes in corrected QT interval

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

    Number of subjects with a clinically significant increase from baseline in corrected QT (QTc) interval onrepeated ECGs

Sponsors and collaborators

Lead sponsor

Regor Pharmaceuticals Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 7, 2024
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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