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Monoclonal Antibodies

U3-1402 for Metastatic Breast Cancer

Phase 2

Recruiting

Research Sponsored by SCRI Development Innovations, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Triple-negative breast cancer (TNBC) patients should have received at least 1 but no more than 5 prior lines of chemotherapy in the metastatic setting

Patients with documented HER2-positive expression as per American Society of Clinical Oncology - College of American Pathologists guidelines based on local testing

Must not have

Leptomeningeal metastases or evidence of spinal cord compression or brain metastases, defined as being clinically active and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms

Chloroquine /hydroxychloroquine ≤14 days prior to the first dose of study drug treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed every 6 weeks for the first 6 months then every 9 weeks thereafter until disease progression or death or up to 33 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer drug to see if it is safe and effective for patients with breast cancer that has spread.

Who is the study for?

This trial is for adults with advanced or metastatic breast cancer who have tried certain treatments without success. Eligible patients must not be pregnant, should agree to use two forms of contraception, and cannot have severe heart conditions or active infections like hepatitis or HIV. They also need to have at least one measurable tumor lesion and acceptable organ function.

What is being tested?

The study tests U3-1402 (patritumab deruxtecan), an antibody drug conjugate, for safety and effectiveness in treating locally advanced or metastatic breast cancer. Participants will receive this experimental medication to see if it helps control their cancer better than current treatments.

What are the potential side effects?

Potential side effects may include reactions related to the immune system such as inflammation of organs, infusion-related reactions which could occur during treatment administration, fatigue, digestive issues like nausea or diarrhea, blood disorders that can affect cell counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have triple-negative breast cancer and received 1-5 chemotherapy treatments for it in the metastatic stage.

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My cancer is HER2-positive according to specific guidelines.

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I have HR+ HER2- breast cancer and was treated with endocrine therapy and a CDK 4/6 inhibitor.

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My breast cancer has spread beyond the initial site.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have active brain or spinal cord complications needing steroids or seizure meds.

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I haven't taken chloroquine or hydroxychloroquine in the last 14 days.

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I have been treated with a HER3-targeting agent before.

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I have a known eye condition from previous treatments.

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I haven't had major surgery in the last 4 weeks.

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I am taking more than 10 mg of prednisone or similar medication daily.

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I do not have any major heart problems before starting the treatment.

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I haven't had extensive radiation therapy recently.

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I have not had any other invasive cancers in the last 3 years.

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I have or might have a lung condition like ILD, pulmonary fibrosis, or radiation pneumonitis.

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I have severe lung problems not related to my cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed every 6 weeks for the first 6 months then every 9 weeks thereafter until disease progression or death or up to 33 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed every 6 weeks for the first 6 months then every 9 weeks thereafter until disease progression or death or up to 33 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed every 6 weeks for the first 6 months then every 9 weeks thereafter until disease progression or death or up to 33 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall response rate (ORR) of single agent U3-1402 (patritumab deruxtecan) in participants with MBC

Rate of participants without disease progression at 6 month to determine six-months Progression Free survival (PFS-6) of single agent U3-1402 (patritumab deruxtecan) in participants with MBC

Secondary study objectives

Clinical Benefit Rate (CBR) in participants with MBC

Incidence of participants with adverse events to assess the safety and tolerability of U3-1402 (patritumab deruxtecan) in participants with MBC

Median Duration of Response (DOR) in participants with MBC

+3 more

Side effects data

From 2023 Phase 1 & 2 trial • 182 Patients • NCT02980341

81%

Nausea

61%

Anaemia

48%

Decreased appetite

45%

Diarrhoea

42%

Vomiting

42%

Platelet count decreased

35%

Constipation

35%

Aspartate aminotransferase increased

32%

White blood cell count decreased

32%

Alanine aminotransferase increased

32%

Fatigue

32%

Neutrophil count decreased

29%

Alopecia

26%

Neutropenia

26%

Thrombocytopenia

23%

Weight decreased

19%

Pyrexia

19%

Abdominal pain

16%

Hypoalbuminaemia

16%

Blood alkaline phosphatase increased

16%

Stomatitis

16%

Epistaxis

16%

Malaise

13%

Back pain

13%

Dry eye

13%

Dehydration

13%

Dizziness

10%

Blood bilirubin increased

10%

Nasopharyngitis

10%

Hypokalaemia

10%

Blood creatinine increased

10%

Headache

Dysuria

Urinary tract infection

Hypomagnesaemia

Haemorrhoids

Tumour haemorrhage

Dyspepsia

Ejection fraction decreased

Insomnia

Abdominal pain upper

Abdominal distension

Rash

Fall

Pleural effusion

Oedema peripheral

Troponin T increased

Taste disorder

Cholecystitis acute

Troponin increased

Ligament sprain

Gastrooesophageal reflux disease

Cancer pain

Upper respiratory tract inflammation

Pancytopenia

Hyponatraemia

Retinal haemorrhage

Cough

Hyperglycaemia

Neuropathy peripheral

Lymphocyte count decreased

Hypotension

Cystitis

Ascites

Hydronephrosis

Peripheral sensory neuropathy

Punctate keratitis

Hypoglycaemia

Electrocardiogram QT prolonged

Contusion

Flatulence

Dyspnoea

Influenza

Dry skin

Conjunctivitis

Febrile neutropenia

Gingival pain

Nasal congestion

Pain in extremity

Oedema

Pruritus

Disease progression

Pigmentation disorder

Gamma-glutamyltransferase increased

Dysphagia

Weight increased

Dysgeusia

Rash pustular

Cataract

Pneumonitis

Palpitations

Oliguria

Depression

100%

80%

60%

40%

20%

Study treatment Arm

Dose Expansion: HER3-High 6.4 mg/kg

Dose Escalation/Dose Finding: Cohort 6.4 mg/kg

Dose Finding: 3.2/4.8/6.4 mg/kg

Dose Expansion: TNBC 6.4 mg/kg

Dose Expansion: HER3-Low 6.4 mg/kg

Dose Escalation: Cohort 8.0 mg/kg

Dose Expansion: HER3 High 4.8 mg/kg

Dose Finding: 4.2/6.4 mg/kg

Dose Escalation: Cohort 1.6 mg/kg

Dose Escalation/Dose Finding: Cohort 4.8 mg/kg

Dose Escalation: Cohort 3.2 mg/kg

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Part ZExperimental Treatment1 Intervention

Participants will receive 5.6 mg/kg U3-1402 (Patritumab Deruxtecan) intravenously on day 1 every 3 weeks. Part Z will enroll an additional 21 participants with HER2+ MBC.

Group II: Part BExperimental Treatment1 Intervention

Participants will receive 5.6 mg/kg U3-1402 intravenously on day 1 every 3 weeks. Part B will enroll 20 participants with metastatic hormone-receptor positive (HR+) HER2-negative cancer and 20 participants with metastatic triple-negative breast cancer (mTNBC), regardless of HER3 expression.

Group III: Part AExperimental Treatment1 Intervention

Participants will receive 5.6 mg/kg U3-1402 (Patritumab Deruxtecan) intravenously on day 1 every 3 weeks. All participants will undergo pre-treatment biopsies. (An archival tissue sample taken within two months of treatment should be provided if it is not medically feasible to provide a pre-treatment biopsy). Up to 60 participants will be enrolled into this arm.

0 / 16Eligibility criteria met