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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

No Placebo-Only Group

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

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

Primary study objectives

Number of Participants With Objective Response Rate Assessed by Investigator Following HER3-DXd Monotherapy (All Cohorts Except Prostate Cancer Cohort)

Secondary study objectives

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

71%

Nausea

52%

Platelet count decreased

48%

Stomatitis

38%

Decreased appetite

38%

Fatigue

38%

Neutrophil count decreased

33%

White blood cell count decreased

33%

Alanine aminotransferase increased

33%

Vomiting

33%

Diarrhoea

29%

Epistaxis

29%

Aspartate aminotransferase increased

29%

Constipation

29%

Alopecia

24%

Nasopharyngitis

24%

Anaemia

19%

Pyrexia

19%

Hypokalaemia

19%

Neutropenia

19%

Thrombocytopenia

14%

Dizziness

14%

Urinary tract infection

14%

Malaise

14%

Back pain

14%

Rash

14%

Hypocalcaemia

14%

Dry skin

14%

Arthralgia

10%

Hypoalbuminaemia

10%

Delirium

10%

Peripheral sensory neuropathy

10%

Taste disorder

10%

Abdominal pain upper

10%

Abdominal distension

10%

Dyspepsia

10%

Abdominal discomfort

10%

Blood alkaline phosphatase increased

10%

Febrile neutropenia

10%

Rash maculo-papular

10%

Myalgia

10%

Abdominal pain

10%

Dyspnoea

10%

Ingrowing nail

10%

Gingival pain

Upper-airway cough syndrome

Oedema peripheral

Dysgeusia

Eczema

Pneumonitis

Arrhythmia

Haemorrhoids

Pruritus

Oedema

Electrocardiogram QT prolonged

Rash pustular

Hepatic function abnormal

Skin hyperpigmentation

Upper respiratory tract infection

Disease progression

Cognitive disorder

Epilepsy

Weight decreased

Leukopenia

Cataract

Pancytopenia

Conjunctivitis

Contusion

Cough

Hyponatraemia

Pneumonia

Palpitations

Extradural haematoma

Dehydration

Gastrooesophageal reflux disease

Hypomagnesaemia

Dysuria

Pneumothorax

Cystitis

Compression fracture

Delirum

Pneumonia aspiration

Headache

Muscular weakness

Dry mouth

Melanocytic naevus

100%

80%

60%

40%

20%

Study treatment Arm

Dose Expansion: HER3-Low 6.4 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/Dose Finding: Cohort 6.4 mg/kg

Dose Expansion: TNBC 6.4 mg/kg

Dose Finding: 3.2/4.8/6.4 mg/kg

Dose Expansion: HER3 High 4.8 mg/kg

Dose Escalation: Cohort 3.2 mg/kg

Dose Escalation: Cohort 8.0 mg/kg

Dose Expansion: HER3-High 6.4 mg/kg

Awards & Highlights

No Placebo-Only Group

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

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