Study of ISB 1302 (CD3 Bispecific Ab) in HER2-positive Metastatic Breast Cancer
Public ClinicalTrials.gov record NCT03983395. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1/2, Open-Label, Dose-Escalation Study of ISB 1302 in Subjects With HER2-Positive Metastatic Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to determine the safety profile, maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of single agent ISB1302 in subjects with HER2-positive metastatic breast cancer who have been treated with all known therapies known to confer clinical benefit.
Study identification
- NCT ID
- NCT03983395
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 1 participant
Conditions and interventions
Conditions
Interventions
- ISB 1302 250 ng/kg Biological
- ISB 1302 325 ng/kg Biological
- ISB 1302 325 ng/kg-D1;425 ng/kg -D8,D15,D22 Biological
- ISB 1302 325 ng/kg-D1;550 ng/kg -D8,D15,D22 Biological
- ISB 1302 325ng/kgD1;550 ng/kg D8;700 ng/kgD15,22 Biological
- ISB 1302 325ng/kg D1;550 ng/kg D8;900 ng/kg D15,22 Biological
- ISB 1302 escalating doses,1200 ng/kg D15,22 Biological
- ISB 1302 at the MTD and/or RP2D dose Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 8, 2020 (Actual)
- Primary completion
- Jul 24, 2020 (Actual)
- Completion
- Jul 24, 2020 (Actual)
- Last update posted
- May 24, 2021
2020
United States locations
- U.S. sites
- 5
- U.S. states
- 5
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ichnos Investigational Site 1 | Gilbert | Arizona | 85234 | — |
| Ichnos Investigational Site 5 | Los Angeles | California | 90048 | — |
| Ichnos Investigational Site 4 | Louisville | Kentucky | 40212 | — |
| Ichnos Investigational Site 2 | Detroit | Michigan | 48201 | — |
| Ichnos Investigational Site 3 | Philadelphia | Pennsylvania | 19107 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03983395, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 24, 2021 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03983395 live on ClinicalTrials.gov.