Clinical trial · Interventional
A Phase I Study of RGT-419B in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer or Other Solid Tumors
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RGT-419B | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RGT-419B monotherapy
- description
- Dose escalation and dose expansion of RGT-419B monotherapy
- interventionNames
- Drug: RGT-419B
Primary outcomes (1)
- measure
- Safety & Tolerability - Number of subjects with Dose-Limiting Toxicities (DLTs) at each cohort dose level
- timeFrame
- 4 weeks (1 cycle)
- description
- 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 (9)
- measure
- Safety & Tolerability - Incidence, Severity, and Causality of all Treatment Emergent Adverse Events (TEAEs)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available