Trials / Terminated
TerminatedNCT04942054
A Study in Patients With Advanced Breast Cancer
A Phase 1 Study to Determine Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of SCO-120 in Hormone Receptor Positive, HER-2 Negative Advanced Breast Cancer Patients
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- Sun Pharma Advanced Research Company Limited · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A Phase 1, Open label, Dose escalation and Dose expansion study of SCO-120 in HR +ve HER2-ve advanced/ metastatic breast cancer (MBC) patients to evalaute the safety, tolerability and prelimnary efficacy. Initial part with dose escalation is to determine the MTD and RP2D, and PK and PD characterisation. RP2D will be further evalauted for prelimnary efficacy in MBC patients with tretament failure on Aromatase Inhibitor/Fulvestrant/CDK4-6 inhibitors with or with out ESR1 mutation.
Detailed description
Part 1 \& 2: Approximately 51 subjects will be enrolled Part 3: Approximately 90 subjects will be enrolled
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Part 1 | Dose escalation cohort |
| DRUG | Part 2 | Pharmacodyanamic (PD) dose exploration cohorts |
| DRUG | Part 3 | Dose expansion at dose(s) ≤ maximum tolerated dose (MTD) cohort |
Timeline
- Start date
- 2022-05-20
- Primary completion
- 2023-02-28
- Completion
- 2023-02-28
- First posted
- 2021-06-28
- Last updated
- 2023-05-22
Locations
6 sites across 2 countries: United States, India
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04942054. Inclusion in this directory is not an endorsement.