Clinical trial NCT06299124: A Phase I Study of RGT-419B in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer or Other Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Breast Cancer
Advanced Solid Tumor
Lead sponsor: Regor Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2024-03-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Safety & Tolerability - Number of subjects with Dose-Limiting Toxicities (DLTs) at each cohort dose level
timeFrame: 4 weeks (1 cycle)
Secondary outcomes:
measure: Safety & Tolerability - Incidence, Severity, and Causality of all Treatment Emergent Adverse Events (TEAEs)
timeFrame: through study completion, an average of 1 year
measure: Day 1 and steady-state pharmacokinetics(PK) assessment of RGT-419B and major metabolites - Cmax
timeFrame: 4 weeks (1 cycle)
measure: Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Area Under Concentration-TimeCurve to Infinity (AUC0-inf)
timeFrame: 4 weeks (1 cycle)
measure: Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Plasma Decay Half-Life (t1/2)
timeFrame: 4 weeks (1 cycle)
measure: Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Time to Reach Maximum ObservedPlasma Concentration (Tmax)
timeFrame: 4 weeks (1 cycle)
measure: Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Accumulation rate after multipledoses
timeFrame: 4 weeks (1 cycle)
measure: Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Cumulative urinary excretion
timeFrame: 4 weeks (1 cycle)
measure: Tumor Response assessed by Investigator according to RECIST v1.1
timeFrame: through study completion, an average of 1 year
measure: QTc Interval - Changes in corrected QT interval
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Jian Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: