AZD5305 for Colorectal Carcinoma (CRC)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Research Site, Poznań, Poland
Colorectal Carcinoma (CRC)+5 More
AZD5305 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

TROPION-PanTumor03 will investigate the safety, tolerability, and anti-tumour activity of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination with Anticancer Agents in Patients with Advanced/Metastatic Solid Tumours.

Eligible Conditions

  • Colorectal Carcinoma (CRC)
  • Endometrial Cancer
  • Metastatic Castration-resistant Prostate Cancer
  • Ovarian Cancer
  • Malignant Neoplasm of Stomach

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Colorectal Carcinoma (CRC)

Study Objectives

2 Primary · 10 Secondary · Reporting Duration: From baseline to progressive disease or death (approximately 1 year)

Year 1
Pharmacokinetic Parameter: Area under the plasma concentration- time curve (AUC)
Pharmacokinetics of Dato-DXd, Maximum plasma concentration of the drug (Cmax)
Pharmacokinetics of Dato-DXd, The time taken to reach the maximum concentration (Tmax)
Year 1
Best percentage change in tumour size
Duration Of Response (DOR)
Objective response rate (ORR)
Progression free survival (PFS)
Year 1
The number of subjects with adverse events/serious adverse events
Year 1
Plasma concentration of MAAA-1181a
Plasma concentration of Total anti-TROP2 antibody
Year 1
Anti Drug Antibody (ADA)
Week 24
Disease Control Rate (DCR)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Colorectal Carcinoma (CRC)

Trial Design

13 Treatment Groups

Substudy-2A
1 of 13
Substudy-2B
1 of 13
Substudy-3B
1 of 13
Substudy-3A
1 of 13
Substudy-1D
1 of 13
Substudy-5A
1 of 13
Substudy-4B
1 of 13
Substudy-1A
1 of 13
Substudy-1C
1 of 13
Substudy-1B
1 of 13
Substudy-2C
1 of 13
Substudy-4A
1 of 13
Substudy-5B
1 of 13
Experimental Treatment

451 Total Participants · 13 Treatment Groups

Primary Treatment: AZD5305 · No Placebo Group · Phase 2

Substudy-2AExperimental Group · 2 Interventions: Capecitabine, Datopotamab deruxtecan (Dato-DXd) · Intervention Types: Drug, Drug
Substudy-2BExperimental Group · 2 Interventions: Datopotamab deruxtecan (Dato-DXd), 5-Fluorouracil · Intervention Types: Drug, Drug
Substudy-3BExperimental Group · 2 Interventions: Datopotamab deruxtecan (Dato-DXd), AZD5305 · Intervention Types: Drug, Drug
Substudy-3A
Drug
Experimental Group · 1 Intervention: Datopotamab deruxtecan (Dato-DXd) · Intervention Types: Drug
Substudy-1DExperimental Group · 3 Interventions: Datopotamab deruxtecan (Dato-DXd), AZD5305, Durvalumab · Intervention Types: Drug, Drug, Drug
Substudy-5A
Drug
Experimental Group · 1 Intervention: Datopotamab deruxtecan (Dato-DXd) · Intervention Types: Drug
Substudy-4BExperimental Group · 3 Interventions: Datopotamab deruxtecan (Dato-DXd), AZD5305, Carboplatin · Intervention Types: Drug, Drug, Drug
Substudy-1A
Drug
Experimental Group · 1 Intervention: Datopotamab deruxtecan (Dato-DXd) · Intervention Types: Drug
Substudy-1C
Drug
Experimental Group · 1 Intervention: Datopotamab deruxtecan (Dato-DXd) · Intervention Types: Drug
Substudy-1BExperimental Group · 2 Interventions: Datopotamab deruxtecan (Dato-DXd), Durvalumab · Intervention Types: Drug, Drug
Substudy-2CExperimental Group · 4 Interventions: Capecitabine, Nivolumab, Datopotamab deruxtecan (Dato-DXd), 5-Fluorouracil · Intervention Types: Drug, Drug, Drug, Drug
Substudy-4A
Drug
Experimental Group · 1 Intervention: Datopotamab deruxtecan (Dato-DXd) · Intervention Types: Drug
Substudy-5BExperimental Group · 5 Interventions: Capecitabine, Leucovorin LV, Bevacizumab, Datopotamab deruxtecan (Dato-DXd), 5-Fluorouracil · Intervention Types: Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capecitabine
2002
Completed Phase 3
~3010
Nivolumab
2014
Completed Phase 3
~5540
Bevacizumab
2014
Completed Phase 4
~4030
5-Fluorouracil
2012
Completed Phase 3
~7440
Carboplatin
2014
Completed Phase 3
~6570
Durvalumab
2017
Completed Phase 2
~3190

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline to progressive disease or death (approximately 1 year)
Closest Location: Research Site · Houston, TX
Photo of Houston  1Photo of Houston  2Photo of Houston  3
1900First Recorded Clinical Trial
22 TrialsResearching Colorectal Carcinoma (CRC)
2948 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are either male or female, ≥ 18 years.
You have a histologically or cytologically documented advanced or metastatic malignancy.
You have a minimum life expectancy of 12 weeks.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.