Advanced Solid Tumor, Breast Cancer
Conditions
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.
Interventions
DRUGRGT-419B
RGT-419B will be administered orally
Sponsors
Regor Pharmaceuticals Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety & Tolerability - Number of subjects with Dose-Limiting Toxicities (DLTs) at each cohort dose level | 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
| Measure | Time frame | Description |
|---|---|---|
| Safety & Tolerability - Incidence, Severity, and Causality of all Treatment Emergent Adverse Events (TEAEs) | 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. |
| 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) | — |
| 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 - 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 | Number of subjects with a clinically significant increase from baseline in corrected QT (QTc) interval onrepeated ECGs |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORJian Zhang, MD
Fudan University
Outcome results
None listed