Summary

Eligibility
for people ages 18-130 (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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.

Official Title

A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination With Anticancer Agents in Patients With Advanced/Metastatic Solid Tumours (TROPION-PanTumor03)

Details

This Phase II, open-label, uncontrolled, multicentre study evaluating the efficacy and safety of Dato-DXd as monotherapy (MONO) and in combination with anticancer agents (COMBO) in various advanced solid tumour types. This study has a modular design, as such a master protocol with independent substudies enables simultaneous evaluation of the safety profile, recommended Phase II dose (RP2D), and efficacy of Dato-DXd in multiple disease populations and treatment combinations. This study will evaluate various solid tumour types, including endometrial cancer (Substudy 1), gastric cancer (Substudy 2), metastatic castration-resistant prostate cancer (mCRPC) (Substudy 3), ovarian cancer (Substudy 4), and colorectal cancer (CRC) (Substudy 5) in the advanced or metastatic setting. Within each substudy, Dato-DXd will be evaluated as monotherapy (for all substudies except Substudy 2, (Gastric Cancer) and in combination with approved or novel anticancer agents that may be active in the tumour type being evaluated.(AZD5305, Durvalumab).

Keywords

Endometrial Cancer Gastric Cancer Metastatic Castration-resistant Prostate Cancer Ovarian Cancer Colorectal Cancer TROPION-PanTumor03 Datopotamab Deruxtecan (Dato-DXd) Solid Tumours Antibody-drug conjugate (ADC) Trophoblast cell surface protein 2 (TROP2) Endometrial Neoplasms Leucovorin Bevacizumab Nivolumab Durvalumab Carboplatin Fluorouracil Capecitabine AZD5305 5-Fluorouracil Leucovorin LV Substudy-1A Substudy-1B Substudy-1C Substudy-1D Substudy-2A Substudy-2B Substudy-2C Substudy-3A Substudy-3B Substudy-4A Substudy-4B Substudy-5A Substudy-5B

Eligibility

You can join if…

Open to people ages 18-130

  • Male and female, ≥ 18 years
  • Histologically or cytologically documented advanced or metastatic malignancy.
  • At least 1 lesion not previously irradiated that qualifies as a RECIST 1.1 target lesion at baseline Substudy 3 (mCRPC) allows enrolment of participants with non measurable (by RECIST 1.1) bone metastatic disease.
  • Adequate bone marrow reserve and organ function within 7 days before randomization/treatment
  • Minimum life expectancy of 12 weeks.

You CAN'T join if...

  • Persistent toxicities caused by previous anticancer therapy, excluding alopecia, not yet improved to Grade ≤ 1 or baseline
  • Spinal cord compression or brain metastases unless treated
  • Leptomeningeal carcinomatosis
  • Clinically significant corneal disease
  • Active hepatitis or uncontrolled hepatitis B or C virus infection
  • Uncontrolled infection requiring IV antibiotics, antivirals or antifungals eg, prodromal symptoms
  • Significant cardiac diseases
  • History of non-infectious Interstitial lung disease (ILD)/pneumonitis that required steroids
  • Prior exposure to chloroquine/hydroxychloroquine without an adequate treatment washout period
  • Prior exposure to anticancer therapies without an adequate treatment washout period prior to enrolment
  • Prior treatment with TROP2-directed Anti-drug antibody ADC Antibody-drug conjugate (ADCs), other ADCs with deruxtecan payload
  • Severe hypersensitivity to Dato-DXd monoclonal antibodies polysorbate 80 or other monoclonal antibodies.
  • Pregnant, breastfeeding, planning to become pregnant.

Locations

  • Research Site not yet accepting patients
    Los Angeles California 90095 United States
  • Research Site not yet accepting patients
    San Diego California 92103 United States
  • Research Site accepting new patients
    Santa Rosa California 92805 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
AstraZeneca
ID
NCT05489211
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 531 study participants
Last Updated