Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Part of paid clinical trials in Los Angeles, California.

Sponsor
AstraZeneca
Study ID
NCT05489211
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Datopotamab deruxtecan (Dato-DXd) — DRUG
    Intravenous (IV) Antibody drug conjugate
  • Capecitabine — DRUG
    Administered orally
  • 5-Fluorouracil — DRUG
    Administered as an IV
  • Volrustomig — DRUG
    Administered as an IV
  • Carboplatin — DRUG
    Administered as an IV
  • Bevacizumab — DRUG
    Administered as an IV
  • Rilvegostomig — DRUG
    Administered as an IV
  • Prednisone/ prednisolone — DRUG
    Administered orally
  • Cisplatin — DRUG
    Administered as an IV

Study Details

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.

Key Dates

Start date
Sep 6, 2022
Status verified
Mar 2026
Primary completion
Oct 1, 2027
Completion
Oct 1, 2027

Study Design

Enrollment
454 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Substudy-1A
    Dato-DXd will be evaluated as monotherapy
  • Experimental: Substudy-2A
    Dato-DXd in combination with capecitabine will be evaluated
  • Experimental: Substudy-2B
    Dato-DXd in combination with 5-FU will be evaluated
  • Experimental: Substudy-3A
    Dato-DXd will be evaluated as monotherapy
  • Experimental: Substudy-3C
    Dato-DXd will be evaluated in combination with prednisone/prednisolone
  • Experimental: Substudy-4A
    Dato-DXd will be evaluated as monotherapy
  • Experimental: Substudy-4C
    Dato-DXd in combination with carboplatin + bevacizumab followed by Dato-DXd + bevacizumab will be evaluated
  • Experimental: Substudy-5A
    Dato-DXd will be evaluated as monotherapy
  • Experimental: Substudy-6A
    Dato-DXd in combination with volrustomig (MEDI5752) will be evaluated
  • Experimental: Substudy-6B
    Data-DXd in combination with rilvegostomig (AZD2936) will be evaluated
  • Experimental: Substudy-6C
    Dato-DXd will be evaluated as monotherapy
  • Experimental: Substudy-6D
    Dato-DXd in combination with carboplatin or cisplatin will be evaluated
  • Experimental: Substudy-6E
    Dato-DXd in combination with rilvegostomig (AZD2936) will be evaluated
  • Experimental: Substudy-7A
    Dato-DXd will be evaluated as monotherapy

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: From baseline to progressive disease or death (approximately 1 year) ]

Central Contacts

Locations (18)

FacilityCityStateZIPSite coordinators
Research SiteLos AngelesCalifornia90095-
Research SiteSan DiegoCalifornia92103-
Research SiteSanta RosaCalifornia95403-
Research SiteMuncieIndiana47303-
Research SiteKansas CityKansas66160-
Research SiteBostonMassachusetts02114-
Research SiteBostonMassachusetts02215-
Research SiteGrand RapidsMichigan49503-
Research SiteEast BrunswickNew Jersey08816-
Research SiteAlbuquerqueNew Mexico87109-
Research SiteCommackNew York11725-
Research SiteCincinnatiOhio45219-
Research SiteColumbusOhio43219-
Research SitePortlandOregon97239-
Research SiteNashvilleTennessee37203-
Research SiteNashvilleTennessee37232-
Research SiteHoustonTexas77030-
Research SiteMadisonWisconsin53792-

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