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Study of ISB 1302 (CD3 Bispecific Ab) in HER2-positive Metastatic Breast Cancer | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

Study of ISB 1302 (CD3 Bispecific Ab) in HER2-positive Metastatic Breast Cancer

A Phase 1/2, Open-Label, Dose-Escalation Study of ISB 1302 in Subjects With HER2-Positive Metastatic Breast Cancer

NCT03983395•Ichnos Sciences SA

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.

Detailed Description

To determine the safety profile, maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of single agent ISB 1302 in subjects with HER2-positive metastatic breast cancer who have been treated with all known therapies known to confer clinical benefit.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Females with HER2-positive \[IHC 2 +, with FISH confirmation\] or 3+ \[IHC or FISH\] metastatic breast cancer that has progressed on last therapy. No more than 4 lines of therapy in metastatic setting (of which no more than 2 lines should be anti-HER2 antibody-based therapy).
•Measurable disease, defined as per RECIST v1.1.
•Eastern Cooperative Oncology Group (ECOG ) performance-status score of 2 or less
•Adequate bone marrow, renal, and liver function.
•Recovered from any previous surgery and no history of major surgery within the last 28 days prior to start of study drug
•Must be willing to undergo pre-treatment and on-treatment biopsies in Part 1 and Part 2.

Exclusion Criteria

•Any suspected or proven immunocompromised state, or infections, such as history of positive human immunodeficiency virus (HIV), known active or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV).
•Any history or evidence of clinically significant cardiovascular disease.
•Evidence of clinically significant cardiovascular and respiratory conditions
•Previous antineoplastic treatment with immune checkpoint regulator or comparable immunotherapy within 8 weeks of starting study drug.
•Chemotherapy, radiotherapy, molecular-targeted therapy, or biological therapies (including HER2-directed therapies) within 4 weeks of starting study drug
•Hormone therapy within 2 weeks of starting study medications.
•Diagnosed with another malignancy that requires active therapy
•Brain metastases that require directed therapy.
•Has not recovered from any therapy related toxicities from previous treatments.
•Use of any investigational drug within 4 weeks from the start of study drug.
+1 more criteria

Locations (5)

Ichnos Investigational Site 1

Gilbert, Arizona, United States

Ichnos Investigational Site 5

Los Angeles, California, United States

Ichnos Investigational Site 4

Louisville, Kentucky, United States

Ichnos Investigational Site 2

Detroit, Michigan, United States

Ichnos Investigational Site 3

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

April 8, 2020

Primary Completion Date

July 24, 2020

Completion Date

July 24, 2020

Last Updated

May 24, 2021

Enrollment

ACTUAL participants

Conditions

Breast Cancer

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 24, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of ISB 1302 (CD3 Bispecific Ab) in HER2-positive Metastatic Breast Cancer

Inclusion Criteria

Exclusion Criteria

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

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