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

Ichnos Sciences

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Breast Cancer

Treatments: Biological: ISB 1302 325 ng/kg-D1;550 ng/kg -D8,D15,D22; Biological: ISB 1302 325 ng/kg-D1;425 ng/kg -D8,D15,D22; Biological: ISB 1302 at the MTD and/or RP2D dose; Biological: ISB 1302 escalating doses,1200 ng/kg D15,22; Biological: ISB 1302 325ng/kgD1;550 ng/kg D8;700 ng/kgD15,22; Biological: ISB 1302 250 ng/kg; Biological: ISB 1302 325ng/kg D1;550 ng/kg D8;900 ng/kg D15,22; Biological: ISB 1302 325 ng/kg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03983395

ISB 1302-103

IND Number 131316 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: Female

Ages: 18+ years old

Volunteers: No 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.
• Any condition that, in the opinion of the Investigator, would interfere with evaluation of the study drug or interpretation of subject safety or study results.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 8 patient groups

Part 1: Cohort 101 - ISB 1302 250 ng/kg

Experimental group

Description:

Cohort 101, subjects will be administered ISB 1302 by intravenous (IV) infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. Dose on D1, D8, D15, D22 is 250 ng/kg

Treatment:

Biological: ISB 1302 250 ng/kg

Part 1: Cohort 201 - ISB 1302 325 ng/kg

Experimental group

Description:

Cohort 201, subjects will be administered ISB 1302 by intravenous (IV) infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. Dose on D1, D8, D15, D22 is 325 ng/kg

Treatment:

Biological: ISB 1302 325 ng/kg

Part 1:Cohort 301- ISB 1302 325 ng/kg-D1;425 ng/kg -D8,D15,D22

Experimental group

Description:

Cohort 301, subjects will be administered ISB 1302 by intravenous (IV) infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at escalating dose levels. Dose of GBR 1302 is 325 ng/kg on D1 and 425 ng/kg on D8, D15, D22

Treatment:

Biological: ISB 1302 325 ng/kg-D1;425 ng/kg -D8,D15,D22

Part 1:Cohort 401- ISB 1302 325 ng/kg-D1;550 ng/kg -D8,D15,D22

Experimental group

Description:

Cohort 401, subjects will be administered ISB 1302 by intravenous (IV) infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at escalating dose levels. Dose of ISB 1302 is 325 ng/kg on D1 and 550 ng/kg on D8, D15, D22

Treatment:

Biological: ISB 1302 325 ng/kg-D1;550 ng/kg -D8,D15,D22

Part1Cohort501-ISB1302 325ng/kgD1;550 ng/kg D8;700 ng/kgD15,22

Experimental group

Description:

Cohort 501, subjects will be administered ISB 1302 by intravenous (IV) infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at escalating dose levels. Dose of ISB 1302 is 325 ng/kg on D1 and 550 ng/kg on D8, and 700 ng/kg on D15, D22

Treatment:

Biological: ISB 1302 325ng/kgD1;550 ng/kg D8;700 ng/kgD15,22

Part1Cohort601-ISB1302 325ng/kgD1;550 ng/kg D8;900 ng/kgD15,22

Experimental group

Description:

Cohort 601, subjects will be administered ISB 1302 by intravenous (IV) infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at escalating dose levels. Dose of ISB 1302 is 325 ng/kg on D1 and 550 ng/kg on D8, and 900 ng/kg on D15, D22

Treatment:

Biological: ISB 1302 325ng/kg D1;550 ng/kg D8;900 ng/kg D15,22

Part 1 Cohort 701- ISB 1302 escalating doses,1200 ng/kg D15,22

Experimental group

Description:

Cohort 701, subjects will be administered ISB 1302 by intravenous (IV) infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at escalating dose levels. Dose of ISB 1302 is 325 ng/kg on D1 and 700 ng/kg on D8, and 1200 ng/kg on D15, D22

Treatment:

Biological: ISB 1302 escalating doses,1200 ng/kg D15,22

Part 2 (Dose Expansion) -ISB 1302 at the MTD and/or RP2D dose

Experimental group

Description:

Subjects treated with ISB 1302 at the MTD and/or RP2D dose in separate groups in the Q1W and/or the Q2W dose regimen.

Treatment:

Biological: ISB 1302 at the MTD and/or RP2D dose