Study on Dato-Dxd Alone and with Other Cancer Treatments for Advanced Solid Tumors (TROPION-PanTumor03)

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT05489211

Provider View

This clinical trial is exploring the safety and effectiveness of a new drug, Datopotamab Deruxtecan (Dato-DXd), used alone or with other cancer treatments in patients with advanced solid tumors.

Patient Parameters

Program Overview

The TROPION-PanTumor03 study aims to test how safe and effective Dato-DXd is when used by itself or combined with other cancer treatments in patients with advanced or metastatic solid tumors. The study will look at different types of cancers, including endometrial, gastric, prostate, ovarian, colorectal, urothelial, and biliary tract cancers. Each type of cancer will be studied separately to see how well Dato-DXd works alone or with other approved or new cancer drugs.

Description

This Phase II study is open-label, meaning both doctors and participants know what treatment is being given. It is conducted at multiple centers and focuses on the effectiveness and safety of Dato-DXd, both as a standalone treatment and in combination with other cancer drugs. The study is divided into substudies, each focusing on a different type of advanced solid tumor, such as endometrial, gastric, prostate, ovarian, colorectal, urothelial, and biliary tract cancers. Dato-DXd will be tested alone in most substudies, except for gastric cancer, and in combination with other cancer drugs in most substudies, except for endometrial and biliary tract cancers.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older.
  • Have advanced or metastatic cancer.
  • Be in good general health with a performance status of 0 or 1.
  • Provide a tumor sample for analysis.
  • Have at least one measurable tumor, except for prostate cancer patients who may have non-measurable bone disease.
  • Have adequate bone marrow and organ function.
  • Have a life expectancy of at least 12 weeks.
  • Use contraception as required by local regulations.
  • Women must have a negative pregnancy test and use effective birth control.
  • Men must use effective birth control if sexually active with a woman of childbearing potential.
  • Be able to give informed consent.
  • Agree to optional genetic research consent.

Exclusion Criteria

  • Have any condition that makes participation unsafe or compliance difficult.
  • Have another primary cancer, except for certain skin cancers or other solid tumors treated with curative intent.
  • Have unresolved side effects from previous cancer treatments.
  • Have untreated spinal cord compression or brain metastases.
  • Have certain infections or uncontrolled diseases.
  • Have a history of heart or lung disease that is not well controlled.
  • Have received certain vaccines or cancer treatments recently.
  • Have had major surgery recently or need major surgery during the study.
  • Have been treated with similar drugs before.
  • Be pregnant, breastfeeding, or planning to become pregnant.
  • Have severe allergies to the study drug or its components.
  • Be involved in planning or conducting the study.
  • Be unlikely to follow study procedures.

Locations

FACILITYZIPCITYSTATE
Research Site90095Los AngelesCalifornia
Research Site92103San DiegoCalifornia
Research Site95403Santa RosaCalifornia
Research Site47303MuncieIndiana
Research Site66160Kansas CityKansas
Research Site02114BostonMassachusetts
Research Site02215BostonMassachusetts
Research Site49503Grand RapidsMichigan
Research Site08816East BrunswickNew Jersey
Research Site87109AlbuquerqueNew Mexico

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