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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)
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 moreTrial 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
~3870
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
Find a Location
Who is running the clinical trial?
Daiichi Sankyo, Inc.Industry Sponsor
389 Previous Clinical Trials
419,627 Total Patients Enrolled
AstraZenecaLead Sponsor
4,268 Previous Clinical Trials
288,611,808 Total Patients Enrolled
Daiichi SankyoIndustry Sponsor
392 Previous Clinical Trials
415,695 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My brain or spinal cord cancer has been treated.My cancer has spread to the lining of my brain and spinal cord.I do not have active or uncontrolled hepatitis B or C.I do not have an infection needing IV drugs.My HIV infection is not well controlled.I have an active TB infection.I can provide a sample of my tumor for testing.My bone marrow and organs are functioning well.I am 18 years old or older.My cancer has spread beyond its original location.I am able to understand and sign the consent form.I have not received a live vaccine in the last 30 days.I have a serious eye condition affecting my cornea.I have had cancer before, but it was either skin cancer treated by removal or another type treated with the intent to cure.I am a woman not capable of becoming pregnant or I'm using effective birth control.I still have side effects from cancer treatment, except for hair loss.I haven't had major surgery or a serious injury in the last 3 weeks and don't expect to need major surgery during the study.I have at least one tumor that can be measured and has not been treated with radiation, except if I have prostate cancer with bone metastasis.I have a serious heart condition.I recently took chloroquine or hydroxychloroquine without a break before starting this trial.I have severe breathing problems.I have signed a consent form for optional genetic research.I have not been treated with TROP2-targeting drugs or deruxtecan-based therapies.I haven't had cancer treatment recently or am not currently on any.I have had lung inflammation treated with steroids.I've been active and my health hasn't worsened in the last 2 weeks.I am a male willing to follow strict birth control rules or I am surgically sterile.
Research Study Groups:
This trial has the following groups:- Group 1: Substudy-2B
- Group 2: Substudy-2C
- Group 3: Substudy-3A
- Group 4: Substudy-1C
- Group 5: Substudy-5A
- Group 6: Substudy-3B
- Group 7: Substudy-5B
- Group 8: Substudy-6B
- Group 9: Substudy-2A
- Group 10: Substudy-1A
- Group 11: Substudy-1D
- Group 12: Substudy- 6A
- Group 13: Substudy-3C
- Group 14: Substudy-1B
- Group 15: Substudy-4A
- Group 16: Substudy-4B
- Group 17: Substudy- 7A
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities for patients to join this investigation?
"According to clinicaltrials.gov, this research project is actively accepting participants. It was initially posted on September 6th 2022 and the last update was made 10 days later."
Answered by AI
Could I be eligible to join this research endeavor?
"This trial is actively searching for 531 people suffering from colorectal carcinoma between 18 and 130 years of age. Notably, these candidates need to meet the following requirements: at least one lesion not previously irradiated that meets RECIST 1.1 criteria; bone metastatic disease measurable or not by RECIST 1.1 (Substudy 3); adequate bone marrow reserve and organ function within a week before randomization/treatment; male or female gender with minimum life expectancy of 12 weeks or more."
Answered by AI
What goals are researchers aiming to accomplish with this investigation?
"The clinical trial sponsor, Daiichi Sankyo, Inc., has outlined the primary objectives. These include measuring adverse events/serious adverse events and best percentage change in tumour size over a 1 year period from baseline. Secondary outcomes that will be evaluated are plasma concentration of total anti-TROP2 antibody and pharmacokinetics of Dato-DXd; specifically the time to attain maximum concentration (Tmax)."
Answered by AI
How many individuals can partake in this research endeavor?
"Affirmative. According to records on clinicaltrials.gov, the trial was uploaded in September 6th 2022 and has since been modified. The medical research is actively recruiting 531 patients from 17 separate sites."
Answered by AI
Does this trial accept participants who are younger than 75 years of age?
"Patients aged between 18 and 130 are eligible for this trial, with 63 studies catering to those younger than 18 years old and 1514 suitable trials available for the elderly."
Answered by AI
Has the FDA granted authorization for AZD5305?
"Though Phase 2 trials have generated evidence in regards to safety, the lack of data on efficacy leads our team at Power to rate AZD5305's security with a score of 2."
Answered by AI
What is the current scope of this clinical trial?
"Currently, 17 medical centres are recruiting individuals for this study. These sites span from Grand Rapids to Houston and Columbus to other cities across the USA. It is beneficial to pick a nearby location in order to reduce travel demands if you elect to participate."
Answered by AI
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