Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RGT-419B monotherapy | Experimental | Dose escalation and dose expansion of RGT-419B monotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RGT-419B | Drug | RGT-419B will be administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Day 1 and steady-state pharmacokinetics(PK) assessment of RGT-419B and major metabolites - Cmax |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jian Zhang, MD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200032 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000095485 | Bulk Drugs |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | 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 |
| D017437 |
| Skin and Connective Tissue Diseases |