A Study to Explore Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of Novel Therapeutics in Patients With Early Relapsed Metastatic Triple-negative Breast Cancer

Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Study ID
NCT06508216
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dato-DXd — DRUG
    Patients in module 1 \& 2 will receive Datopotamab Deruxtecan (Dato-DXd) 6mg/kg every 21 days
  • Durvalumab — DRUG
    Patients in module 2 only will receive Durvalumab 1120mg every 21 days

Study Details

Choice Of the Most Active Strategies for Short term recurring Triple Negative Breast Cancer: A phase Ib/II, open-label, modular, dose-finding and dose-expansion study to explore safety, tolerability, pharmacokinetics, and anti-tumor activity of novel therapeutics in patients with early relapsed metastatic triple-negative breast cancer

Key Dates

Start date
Jul 5, 2024
Status verified
Jul 2024
Primary completion
Dec 17, 2025
Completion
Dec 17, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Module 1 of part 2 : Datopotamab Deruxtecan (Dato-DXd) Monotherapy
    Patients will receive Datopotamab Deruxtecan 6mg/kg every 21 days until progression or until unacceptable toxicity
  • Experimental: Module 2 of part 2 : Datopotamab Deruxtecan (Dato-DXd) + Durvalumab
    Patients will receive Datopotamab Deruxtecan 6mg/kg and durvalumab 1120mg every 21 days until progression or until unacceptable toxicity

Primary Outcome Measure

Part 2_Efficacy of study therapies in each module_objective response rate (ORR) at 6 months. [ Time Frame: Within the 6 months of treatment initiation ]

Central Contacts

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