What side effects are associated with this type of intervention?

Common side effects of treatments for solid tumors, particularly antibody-drug conjugates like DS-8201a, include infusion-related reactions (chills, fever, nausea), gastrointestinal issues (diarrhea, vomiting), hematologic toxicities (neutropenia, anemia), and potential cardiac dysfunction. These therapies may also cause specific toxicities related to the cytotoxic drug component, such as neuropathy or skin reactions.

What prior FDA approvals exist?

Antibody-drug conjugates (ADCs) have been approved by the FDA for the treatment of various solid tumors. Notable examples include trastuzumab emtansine (T-DM1) for HER2-positive breast cancer and enfortumab vedotin for urothelial carcinoma. These ADCs work by combining the targeting capability of monoclonal antibodies with the cancer-killing ability of cytotoxic drugs, thereby delivering the drug directly to cancer cells while minimizing damage to normal cells. DS-8201a, also known as trastuzumab deruxtecan, is another ADC currently being studied for its efficacy in treating advanced solid malignant tumors.

What other types of research exist?

Promising novel alternatives to DS-8201a for solid tumor patients in 2024 include: 1) Pembrolizumab (an immune checkpoint inhibitor) combined with chemotherapy, as seen in the KEYNOTE trials for various cancers. 2) Atezolizumab (another immune checkpoint inhibitor) combined with bevacizumab and chemotherapy, particularly for non-small cell lung cancer and renal cell carcinoma. 3) Regorafenib (a multitargeted kinase inhibitor) for advanced solid tumors, showing activity in phase II trials. 4) Enzalutamide, particularly for prostate cancer, as demonstrated in the TERRAIN and STRIVE trials. These therapies have shown efficacy in clinical trials and represent promising options for solid tumor patients.

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Anti-tumor Antibiotic

DS-8201a for Solid Cancers

Phase 1

Waitlist Available

Research Sponsored by Daiichi Sankyo Co., Ltd.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from 6 months postdose of last participant up to 3 years 5 months

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing a new drug called DS-8201a. It is aimed at patients with advanced solid tumors. The drug works by targeting cancer cells and delivering medicine directly to them.

Who is the study for?

This trial is for adults with advanced solid tumors, particularly those with certain types of breast or stomach cancer that have HER2 overexpression and haven't responded to standard treatments. Participants should be relatively active (ECOG PS 0 or 1) and have a healthy heart function (LVEF ≥ 50%). Those with significant heart issues, arrhythmias, or lung diseases cannot join.

What is being tested?

The study is testing different doses of DS-8201a, an investigational drug for treating various advanced solid malignant tumors. It's an open-label study where all participants know they're receiving the drug; it aims to assess the safety and how well people can tolerate different doses.

What are the potential side effects?

While specific side effects are not listed here, common ones associated with cancer drugs like DS-8201a may include nausea, fatigue, hair loss, increased risk of infection due to low blood cell counts, diarrhea, and potential heart problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from 6 months postdose of last participant up to 3 years 5 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from 6 months postdose of last participant up to 3 years 5 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from 6 months postdose of last participant up to 3 years 5 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

Objective Response Rate (ORR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases)

Secondary study objectives

Best Overall Response Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases)

Disease Control Rate (DCR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases)

Duration of Response (DoR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Expansion Phases)

+8 more

Side effects data

From 2023 Phase 1 trial • 292 Patients • NCT02564900

71%

Nausea

52%

Fatigue

48%

Vomiting

43%

Diarrhoea

33%

Anaemia

33%

Decreased appetite

33%

Constipation

29%

Alopecia

19%

Oedema peripheral

19%

White blood cell count decreased

19%

Stomatitis

19%

Electrocardiogram QT prolonged

14%

Dizziness

14%

Weight decreased

14%

Platelet count decreased

14%

Neutrophil count decreased

14%

Aspartate aminotransferase increased

14%

Dysgeusia

14%

Dyspnoea

14%

Flatulence

10%

Dry eye

10%

Chest discomfort

10%

Hypercalcaemia

10%

Anxiety

10%

Neuropathy peripheral

10%

Epistaxis

10%

Malaise

10%

Hypoalbuminaemia

10%

Palpitations

10%

Cough

10%

Dyspepsia

10%

Back pain

Hyponatraemia

Pneumonitis

Gingival bleeding

Streptococcal bacteraemia

Pulmonary embolism

Hypokalaemia

Cellulitis

Insomnia

Abdominal pain

Gastrooesophageal reflux disease

Myalgia

Blood lactate dehydrogenase increased

Sinusitis

Cancer pain

Muscular weakness

Oral herpes

Pain in extremity

Cataract

Fall

Nasal congestion

Dysphonia

Musculoskeletal pain

Pyrexia

Alanine aminotransferase increased

Blood creatinine increased

Febrile neutropenia

Upper respiratory tract infection

Infusion-related reaction

Influenza

Hyperkalaemia

Peripheral sensory neuropathy

Conjunctival haemorrhage

Folliculitis

Rhinorrhoea

Abdominal distension

Abdominal pain upper

Ascites

Dry mouth

Dry skin

Pruritus

Dermatitis acneiform

Arthralgia

Tachycardia

100%

80%

60%

40%

20%

Study treatment Arm

Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg

Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg

Dose Escalation: Cohort 5, 6.4 mg/kg

Dose Escalation: Cohort 6, 8.0 mg/kg

Dose Escalation: Cohort 1, 0.8 mg/kg

Dose Escalation: Cohort 2, 1.6 mg/kg

Dose Escalation: Cohort 3, 3.2 mg/kg

Dose Escalation: Cohort 4, 5.4 mg/kg

Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg

Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg

Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg

Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg

Dose Expansion: HER2-expressing Other Solid Tumors

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2 Dose expansionExperimental Treatment3 Interventions

Part 2 is a dose expansion to examine the safety and efficacy of DS-8201a and it is consist of multiple cohorts: in subjects with trastuzumab emtansine (T-DM1)-treated HER2 overexpressing breast cancer (Part 2a); trastuzumab-treated HER2 overexpressing gastric or gastroesophageal junction adenocarcinoma (Part 2b); HER2 low expressing breast cancer (Part 2c), HER2 expressing other solid malignant tumor (Part 2d); HER2 expressing breast cancer (Japan only; Part 2e)

Group II: Part 1 Dose escalationExperimental Treatment2 Interventions

Part 1 is a dose escalation to identify the Maximum Tolerated dose (MTD) or the recommended phase 2 dose of DS-8201a guided by the modified continuous reassessment method using a Bayesian logistic regression model following escalation with overdose control principal.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trastuzumab deruxtecan

FDA approved

Trastuzumab deruxtecan

FDA approved

Trastuzumab deruxtecan

FDA approved

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Antibody-Drug Conjugates (ADCs) like DS-8201a work by combining the targeting ability of monoclonal antibodies with the cancer-killing power of cytotoxic drugs. The antibody component specifically binds to antigens on the surface of cancer cells, delivering the cytotoxic drug directly to the tumor, which minimizes damage to healthy cells. This targeted approach is crucial for solid tumor patients as it enhances the efficacy of the treatment while reducing systemic toxicity. Other common treatments for solid tumors include chemotherapy, which kills rapidly dividing cells but can affect healthy tissues, and immunotherapy, which boosts the body's immune response against cancer cells. The precision of ADCs offers a promising advancement in reducing side effects and improving outcomes for patients with solid tumors.