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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 below

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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.

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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.

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My cancer is a type of head or neck cancer.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 27 months for reporting.

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 more

Side effects data

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

67%

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%

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).

0 / 8Eligibility criteria met

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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

~225 spots leftby Jun 2025

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