What side effects are associated with this type of intervention?

Common treatments for bladder cancer, such as antibody-drug conjugates like enfortumab vedotin, often result in side effects including fatigue, peripheral neuropathy, rash, and gastrointestinal issues such as nausea and diarrhea. More severe adverse events can include hyperglycemia, neutropenia, and infusion-related reactions. Traditional chemotherapy agents, often used in combination or as alternatives, can cause myelosuppression, hair loss, and increased risk of infection. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

Enfortumab vedotin is an FDA-approved antibody-drug conjugate for the treatment of locally advanced or metastatic urothelial carcinoma, a type of bladder cancer. It targets Nectin-4 and has shown efficacy in patients previously treated with platinum-based chemotherapy and checkpoint inhibitors. This approval is similar to the investigational drug Datopotamab Deruxtecan, which targets Trop-2, another surface protein, and is being studied for its potential in treating advanced solid tumors, including bladder cancer.

What other types of research exist?

Promising novel alternatives to Datopotamab Deruxtecan for bladder cancer patients include: <ol> <li>EC140 and EC145: Folate-targeted Vinca alkaloid conjugates that have shown activity against folate receptor-positive tumors.</li> <li></li> </ol> DAB486IL-2: A fusion toxin targeting the IL-2 receptor, which has shown activity in hematological cancers and may be relevant for solid tumors expressing the IL-2 receptor. 3. Raltitrexed combinations: Particularly with irinotecan or oxaliplatin, which have shown efficacy in second-line treatment settings for other cancers and may be applicable to bladder cancer.

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Antibody-Drug Conjugate

Dato-DXd Combination Therapy for Advanced Cancers

Phase 2

Recruiting

Led By Global Clinical Lead, MD

Research Sponsored by AstraZeneca

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 baseline to death (approximately 1 year)

Awards & highlights

Study Summary

This trial will investigate the safety and effectiveness of a new cancer drug, given alone or with other cancer drugs.

Who is the study for?

This trial is for adults with advanced or metastatic solid tumors, such as biliary tract, colorectal, ovarian, bladder, endometrial, stomach or prostate cancer. Participants must have a life expectancy of at least 12 weeks and at least one measurable lesion not previously treated with radiation. They should have good organ function but can't join if they're pregnant, have severe allergies to certain drugs in the study, uncontrolled infections or significant heart diseases.Check my eligibility

What is being tested?

The TROPION-PanTumor03 trial is testing Datopotamab Deruxtecan (Dato-DXd) alone and combined with other anti-cancer agents like Bevacizumab and Durvalumab. The goal is to assess safety and how well these treatments work against various advanced cancers.See study design

What are the potential side effects?

Possible side effects include allergic reactions to Dato-DXd or other monoclonal antibodies used in the trial. There's also a risk of infection from IV antibiotics needed for uncontrolled infections that may arise during treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to death (approximately 1 year)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to death (approximately 1 year)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to death (approximately 1 year) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective response rate (ORR)

PSA50 response (Substudy 3 only)

The number of subjects with adverse events/serious adverse events

Secondary outcome measures

Anti Drug Antibody (ADA) for Dato-DXd (all substudies), Durvalumab (substudy 1), volrustomig and rilvegostomig (substudy 6)

Neoplasms

CA-125 response (Substudy 4)

+10 more

Trial Design

17Treatment groups

Experimental Treatment

Group I: Substudy-6BExperimental Treatment2 Interventions

Data-DXd in combination with rilvegostomig (AZD2936) will be evaluated

Group II: Substudy-5BExperimental Treatment5 Interventions

Dato-DXd + 5-FU + LV + bevacizumab OR Dato-DXd + capecitabine + bevacizumab will be evaluated

Group III: Substudy-5AExperimental Treatment1 Intervention

Dato-DXd will be evaluated as monotherapy

Group IV: Substudy-4BExperimental Treatment3 Interventions

Dato-DXd in combination with carboplatin followed by Dato-DXd + Saruparib (AZD5305) will be evaluated

Group V: Substudy-4AExperimental Treatment1 Intervention

Dato DXd will be evaluated as monotherapy

Group VI: Substudy-3CExperimental Treatment2 Interventions

Dato-DXd will be evaluated in combination with prednisone/prednisolone

Group VII: Substudy-3BExperimental Treatment2 Interventions

Dato-DXd in combination with Saruparib (AZD5305) will be evaluated

Group VIII: Substudy-3AExperimental Treatment1 Intervention

Dato-DXd will be evaluated as monotherapy

Group IX: Substudy-2CExperimental Treatment4 Interventions

Dato-DXd in combination with chemotherapy (capecitabine or 5-FU) + volrustomig (MEDI5752) will be evaluated

Group X: Substudy-2BExperimental Treatment2 Interventions

Dato-DXd in combination with 5-FU will be evaluated

Group XI: Substudy-2AExperimental Treatment2 Interventions

Dato-DXd in combination with capecitabine will be evaluated

Group XII: Substudy-1DExperimental Treatment3 Interventions

Dato-Dxd in combination with Durvalumab + Saruparib (AZD5305) will be evaluated

Group XIII: Substudy-1CExperimental Treatment2 Interventions

Dato-Dxd in combination with Saruparib (AZD5305) will be evaluated

Group XIV: Substudy-1BExperimental Treatment2 Interventions

Dato-Dxd in combination with Durvalumab will be evaluated

Group XV: Substudy-1AExperimental Treatment1 Intervention

Dato-DXd will be evaluated as monotherapy

Group XVI: Substudy- 7AExperimental Treatment1 Intervention

Dato-DXd will be evaluated as monotherapy

Group XVII: Substudy- 6AExperimental Treatment2 Interventions

Dato-DXd in combination with volrustomig (MEDI5752) will be evaluated

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab

2017

Completed Phase 2

~3840

Carboplatin

2014

Completed Phase 3

~6670

Bevacizumab

2013

Completed Phase 4

~5280

Capecitabine

2013

Completed Phase 3

~3420

5-Fluorouracil

2012

Completed Phase 3

~7800

Do I qualify?Apply below to find out

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

Bladder cancer treatments include surgery, chemotherapy, radiation therapy, immunotherapy, and targeted therapies. Surgery, such as cystectomy, physically removes the tumor. Chemotherapy uses drugs to kill rapidly dividing cancer cells, while radiation therapy uses high-energy rays to destroy cancer cells. Immunotherapy, including checkpoint inhibitors, boosts the body's immune system to recognize and attack cancer cells. Targeted therapies, like antibody-drug conjugates (ADCs), combine an antibody specific to a cancer cell marker (e.g., Trop-2) with a cytotoxic drug, delivering the drug directly to cancer cells and minimizing damage to normal cells. This targeted approach is crucial for bladder cancer patients as it can enhance treatment efficacy and reduce side effects, improving overall outcomes.

[The role of immunotherapy in the modern treatment of urothelial carcinoma].

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Who is running the clinical trial?

Daiichi Sankyo, Inc.Industry Sponsor

389 Previous Clinical Trials

420,025 Total Patients Enrolled

AstraZenecaLead Sponsor

4,291 Previous Clinical Trials

288,619,747 Total Patients Enrolled

Daiichi SankyoIndustry Sponsor

396 Previous Clinical Trials

418,548 Total Patients Enrolled

Media Library

Datopotamab deruxtecan (Dato-DXd) (Antibody-Drug Conjugate) Clinical Trial Eligibility Overview. Trial Name: NCT05489211 — Phase 2

Bladder Cancer Research Study Groups: Substudy-2B, Substudy-2C, Substudy-3A, Substudy-1C, Substudy-5A, Substudy-3B, Substudy-5B, Substudy-6B, Substudy-2A, Substudy-1A, Substudy-1D, Substudy- 6A, Substudy-3C, Substudy-1B, Substudy-4A, Substudy-4B, Substudy- 7A

Bladder Cancer Clinical Trial 2023: Datopotamab deruxtecan (Dato-DXd) Highlights & Side Effects. Trial Name: NCT05489211 — Phase 2

Datopotamab deruxtecan (Dato-DXd) (Antibody-Drug Conjugate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05489211 — Phase 2

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