Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03983395 · ClinicalTrials.gov registry record · Phase 1
Study of ISB 1302 (CD3 Bispecific Ab) in HER2-positive Metastatic Breast Cancer
A Phase 1 study, sponsored by Ichnos Sciences.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT03983395: Clinical Trial Phase 1 study, sponsored by Ichnos Sciences.
NCT03983395 is a Phase 1 study that was terminated before completion, run by Ichnos Sciences. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03983395, a Phase 1 study, was terminated before completion, sponsored by Ichnos Sciences.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
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.
Primary Outcome
MTD: Number of DLTs (dose limiting toxicities) during the first 28 days after the first administrations of study drug (i.e. Cycle 1) in each cohort.
Interventions
- BIOLOGICAL 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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2020-04-08 |
| Est. Completion | 2020-07-24 |
| Phase | Phase 1 |
Why NCT03983395 stopped before completion
NCT03983395 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 5 interventions - of which ISB 1302 250 ng/kg is the first listed.
NCT03983395 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03983395 about?
NCT03983395 is a clinical study titled "Study of ISB 1302 (CD3 Bispecific Ab) in HER2-positive Metastatic Breast Cancer". 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.
What is the current status of trial NCT03983395?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2020-04-08. Estimated completion is 2020-07-24.
What interventions are being tested in trial NCT03983395?
The interventions under investigation include: 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).
Who is sponsoring clinical trial NCT03983395?
This trial is sponsored by Ichnos Sciences, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03983395's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI