Study of [177Lu]Lu-DWJ155 and [68Ga]Ga-DWJ155 in Patients With Solid Tumors

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07660055
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • [68Ga]Ga-DWJ155 — DIAGNOSTIC_TEST
    Radioligand imaging agent
  • [177Lu]Lu-DWJ155 — DRUG
    Radioligand therapy

Study Details

The purpose of this phase I study is to evaluate the safety, tolerability, dosimetry, and preliminary anti-tumor activity of \[177Lu\]Lu-DWJ155 and the safety and imaging properties of \[68Ga\]Ga-DWJ155 in patients with histologically or cytologically confirmed advanced HER2+, HR+/HER2-negative, or triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), HER2-3+ or 2+ (ISH positive or negative) gastric/gastroesophageal junction (GEJ) cancer, and bladder cancer.

Key Dates

First listed
Jun 22, 2026
Start date
Jun 16, 2026
Status verified
Jun 2026
Primary completion
May 24, 2032
Completion
May 24, 2032

Study Design

Enrollment
156 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation
    Patients will receive \[68Ga\]Ga-DWJ155 and, if eligible, \[177Lu\]Lu-DWJ155. In this part, multiple dose levels of \[177Lu\]Lu-DWJ155 will be evaluated.
  • Experimental: Dose Expansion
    Patients will receive \[68Ga\]Ga-DWJ155 and, if eligible, \[177Lu\]Lu-DWJ155 at the recommended dose established during the dose escalation part.

Primary Outcome Measure

Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) of [177Lu]Lu-DWJ155 [ Time Frame: Up to approximately 53 months ]

Central Contacts

  • Novartis Pharmaceuticals
    1-888-669-6682
    [email protected]
  • Novartis Pharmaceuticals
    +41613241111

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