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Antibody-drug Conjugate
HER3-DXd for Cancer
Phase 2
Recruiting
Research Sponsored by Daiichi Sankyo, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Disease progression after having received treatment with a PBC regimen with or without anti-PD-1 therapy
OR Gastric or GEJ adenocarcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 27 months
Awards & highlights
Summary
This trial is testing a new treatment called HER3-DXd in patients with advanced or spreading solid tumors like melanoma, head and neck cancer, gastric cancer, ovarian cancer, and others.
Who is the study for?
This trial is for adults with advanced or metastatic solid tumors, including specific types of melanoma, head and neck cancers, gastric cancer, ovarian carcinoma, cervical cancer, endometrial cancer, bladder cancer, esophageal carcinoma, pancreatic carcinoma and prostate cancer. Participants must have experienced disease progression after prior treatments.
What is being tested?
The study tests HER3-DXd monotherapy in patients with various solid tumors. It focuses on those who've had previous treatments but their disease has progressed. The goal is to see how effective this new therapy is on its own.
What are the potential side effects?
While the exact side effects are not provided here, similar therapies often cause reactions at the injection site, fatigue, nausea and increased risk of infections. Side effects can vary based on individual patient factors.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has worsened despite treatment with a PBC regimen and possibly anti-PD-1 therapy.
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My cancer is in the stomach or where the stomach meets the esophagus.
Select...
My melanoma worsened despite BRAF/MEK inhibitor treatment.
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My melanoma is on the skin or in nail areas.
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My melanoma diagnosis was confirmed through tissue examination.
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My cancer progressed after treatment with anti-PD-1 or anti-PD-L1 therapy.
Select...
My cancer is a type of head or neck cancer.
Select...
My cancer is in my mouth, throat, or voice box and may or may not be caused by HPV.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 27 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 27 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Objective Response Rate Assessed by Investigator Following HER3-DXd Monotherapy (All Cohorts Except Prostate Cancer Cohort)
Secondary outcome measures
Clinical Benefit Rate As Assessed by Investigator Following HER3-DXd Monotherapy (All Cohorts Except Prostate Cancer Cohort)
Disease Control Rate As Assessed by Investigator Following HER3-DXd Monotherapy (All Cohorts Except Prostate Cancer Cohort)
Duration of Response As Assessed by Investigator Following HER3-DXd Monotherapy (All Cohorts Except Prostate Cancer Cohort)
+6 moreSide effects data
From 2023 Phase 1 & 2 trial • 182 Patients • NCT0298034167%
Nausea
67%
Decreased appetite
67%
Vomiting
33%
Influenza
33%
Upper respiratory tract infection
33%
Anaemia
33%
Hyperkalaemia
33%
Dry eye
33%
Rash
33%
Arthralgia
33%
Oedema
33%
Aspartate aminotransferase increased
33%
Alanine aminotransferase increased
33%
Weight decreased
33%
Blood pressure increased
33%
Atelectasis
33%
Melanocytic naevus
33%
Hypokalaemia
33%
Hypoalbuminaemia
33%
Insomnia
33%
Headache
33%
Peripheral sensory neuropathy
33%
Constipation
33%
Ascites
33%
Rash maculo-papular
33%
Fatigue
33%
Pyrexia
33%
Blood bilirubin increased
33%
Blood creatinine phosphokinase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dose Escalation: Cohort 1.6 mg/kg
Dose Escalation/Dose Finding: Cohort 4.8 mg/kg
Dose Escalation: Cohort 3.2 mg/kg
Dose Finding: 4.2/6.4 mg/kg
Dose Expansion: HER3-Low 6.4 mg/kg
Dose Escalation/Dose Finding: Cohort 6.4 mg/kg
Dose Escalation: Cohort 8.0 mg/kg
Dose Finding: 3.2/4.8/6.4 mg/kg
Dose Expansion: HER3 High 4.8 mg/kg
Dose Expansion: HER3-High 6.4 mg/kg
Dose Expansion: TNBC 6.4 mg/kg
Trial Design
1Treatment groups
Experimental Treatment
Group I: HER3-DXd MonotherapyExperimental Treatment1 Intervention
Participants with locally advanced or metastatic cancer (melanoma, head and neck, gastric cancer, ovarian carcinoma, cervical cancer, endometrial cancer, bladder cancer, esophageal carcinoma, pancreatic carcinoma, and prostate cancer) will receive an intravenous infusion of HER3-DXd monotherapy 5.6 mg/kg every 3 weeks (Q3W).
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Who is running the clinical trial?
Daiichi Sankyo, Inc.Lead Sponsor
389 Previous Clinical Trials
422,200 Total Patients Enrolled
5 Trials studying Ovarian Cancer
1,405 Patients Enrolled for Ovarian Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,950 Previous Clinical Trials
5,174,706 Total Patients Enrolled
42 Trials studying Ovarian Cancer
6,524 Patients Enrolled for Ovarian Cancer
Daiichi SankyoLead Sponsor
401 Previous Clinical Trials
446,660 Total Patients Enrolled
5 Trials studying Ovarian Cancer
1,405 Patients Enrolled for Ovarian Cancer
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