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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
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 belowSelect...
I have triple-negative breast cancer and received 1-5 chemotherapy treatments for it in the metastatic stage.
Select...
My cancer is HER2-positive according to specific guidelines.
Select...
I have HR+ HER2- breast cancer and was treated with endocrine therapy and a CDK 4/6 inhibitor.
Select...
My breast cancer has spread beyond the initial site.
Select...
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:Select...
I do not have active brain or spinal cord complications needing steroids or seizure meds.
Select...
I haven't taken chloroquine or hydroxychloroquine in the last 14 days.
Select...
I have been treated with a HER3-targeting agent before.
Select...
I have a known eye condition from previous treatments.
Select...
I haven't had major surgery in the last 4 weeks.
Select...
I am taking more than 10 mg of prednisone or similar medication daily.
Select...
I do not have any major heart problems before starting the treatment.
Select...
I haven't had extensive radiation therapy recently.
Select...
I have not had any other invasive cancers in the last 3 years.
Select...
I have or might have a lung condition like ILD, pulmonary fibrosis, or radiation pneumonitis.
Select...
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
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 moreSide effects data
From 2023 Phase 1 & 2 trial • 182 Patients • NCT0298034167%
Nausea
55%
Decreased appetite
45%
Platelet count decreased
45%
Neutrophil count decreased
45%
Vomiting
45%
Diarrhoea
39%
Anaemia
36%
White blood cell count decreased
33%
Alanine aminotransferase increased
33%
Aspartate aminotransferase increased
30%
Fatigue
27%
Malaise
24%
Constipation
24%
Weight decreased
24%
Hypokalaemia
21%
Alopecia
18%
Hypoalbuminaemia
18%
Blood bilirubin increased
18%
Stomatitis
18%
Headache
15%
Nasopharyngitis
15%
Hypomagnesaemia
15%
Arthralgia
15%
Pyrexia
12%
Hyponatraemia
12%
Neutropenia
12%
Thrombocytopenia
12%
Back pain
12%
Epistaxis
12%
Dry skin
9%
Cystitis
9%
Dizziness
9%
Haemorrhoids
9%
Lymphocyte count decreased
9%
Mental status changes
9%
Pain
9%
Taste disorder
9%
Oedema peripheral
9%
Insomnia
9%
Abdominal distension
9%
Dry eye
9%
Nasal congestion
6%
Blood creatinine increased
6%
Peripheral sensory neuropathy
6%
Dehydration
6%
Keratitis
6%
Pharyngitis
6%
Cough
6%
Abdominal pain upper
6%
Depression
6%
Visual impairment
6%
Deep vein thrombosis
6%
Hyperglycaemia
6%
Hypercalcaemia
6%
Dyspepsia
6%
Hypotension
6%
Gastrooesophageal reflux disease
6%
Hyperaesthesia teeth
6%
Rib fracture
6%
Somnolence
6%
Vertigo
6%
Contusion
6%
Weight increased
6%
Dry mouth
6%
Salivary hypersecretion
6%
Vulvovaginal dryness
6%
Lymphoedema
6%
Paronychia
6%
Dysgeusia
6%
Anxiety
6%
Dysphagia
6%
Urinary tract infection
3%
Sinus tachycardia
3%
Pain in extremity
3%
Rash
3%
Disease progression
3%
Conjunctivitis
3%
Conjunctivitis allergic
3%
Muscular weakness
3%
Hepatic encephalopathy
3%
Superior vena cava syndrome
3%
Neuropathy peripheral
3%
Pneumonitis
3%
Rash maculo-papular
3%
Blood alkaline phosphatase increased
3%
Ejection fraction decreased
3%
Hypocalcaemia
3%
Herpes zoster
3%
Febrile neutropenia
3%
Dyspnoea
3%
Infusion related reaction
3%
Oropharyngeal pain
3%
Gingival pain
3%
Fall
3%
Confusional state
3%
Rhinorrhoea
3%
Infusion site extravasation
3%
Pneumonia
3%
Biliary obstruction
3%
Urticaria
3%
Pulmonary embolism
3%
Pleural effusion
3%
Abdominal pain
3%
Myalgia
3%
Asthenia
3%
Eczema
3%
Pericardial effusion
3%
Peripheral sweling
3%
Rhinitis allergic
3%
Ascites
3%
Pruritus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dose Expansion: HER3 High 4.8 mg/kg
Dose Escalation/Dose Finding: Cohort 4.8 mg/kg
Dose Finding: 3.2/4.8/6.4 mg/kg
Dose Escalation/Dose Finding: Cohort 6.4 mg/kg
Dose Expansion: HER3-High 6.4 mg/kg
Dose Expansion: TNBC 6.4 mg/kg
Dose Expansion: HER3-Low 6.4 mg/kg
Dose Escalation: Cohort 1.6 mg/kg
Dose Finding: 4.2/6.4 mg/kg
Dose Escalation: Cohort 8.0 mg/kg
Dose Escalation: Cohort 3.2 mg/kg
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.
Find a Location
Who is running the clinical trial?
Daiichi SankyoIndustry Sponsor
406 Previous Clinical Trials
449,083 Total Patients Enrolled
26 Trials studying Breast Cancer
17,629 Patients Enrolled for Breast Cancer
SCRI Development Innovations, LLCLead Sponsor
191 Previous Clinical Trials
13,433 Total Patients Enrolled
26 Trials studying Breast Cancer
2,464 Patients Enrolled for Breast Cancer
Daiichi Sankyo, Inc.Industry Sponsor
389 Previous Clinical Trials
422,551 Total Patients Enrolled
28 Trials studying Breast Cancer
19,604 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have any severe side effects from past treatments, except for hair loss.I do not have active brain or spinal cord complications needing steroids or seizure meds.I haven't taken chloroquine or hydroxychloroquine in the last 14 days.I haven't taken any cancer drugs or been in a cancer study in the last 3 weeks.You must have at least one measurable tumor according to specific guidelines, except if the cancer has only spread to the bones.I am using two forms of birth control, including a barrier method, and will continue for 7 months after the last dose.I have been treated with a HER3-targeting agent before.I agree not to father a child during the study and for 7 months after.I have a known eye condition from previous treatments.I haven't had major surgery in the last 4 weeks.I do not have severe illnesses like uncontrolled high blood pressure, diabetes, bleeding disorders, or active infections including hepatitis B, C, or HIV.I had brain metastases treatment over 4 weeks ago, no worsening, mild symptoms, and don't need steroids.My breast cancer is HER2-negative and I've received specific treatments.I am taking more than 10 mg of prednisone or similar medication daily.I do not have any major heart problems before starting the treatment.I have triple-negative breast cancer and received 1-5 chemotherapy treatments for it in the metastatic stage.My cancer is HER2-positive according to specific guidelines.I have HR+ HER2- breast cancer and was treated with endocrine therapy and a CDK 4/6 inhibitor.I haven't had extensive radiation therapy recently.My breast cancer has spread beyond the initial site.I have not had any other invasive cancers in the last 3 years.My organs are functioning well enough for treatment.I am 18 years old or older and have signed the consent form.I am willing to have biopsies before and during treatment, and my tumor can be biopsied.I have or might have a lung condition like ILD, pulmonary fibrosis, or radiation pneumonitis.I have severe lung problems not related to my cancer.I am fully active or restricted in physically strenuous activity but can do light work.
Research Study Groups:
This trial has the following groups:- Group 1: Part A
- Group 2: Part B
- Group 3: Part Z
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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