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

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.

Trial Details

NCT ID
NCT07660055
Phase
PHASE1
Sponsor
Novartis Pharmaceuticals
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • [68Ga]Ga-DWJ155
  • [177Lu]Lu-DWJ155
Locations (sample)
  • Omaha, Nebraska, United States|41.25626,-95.94043
  • Darlinghurst, New South Wales, Australia|-33.87939,151.21925
  • Montreal, Quebec, Canada|45.50884,-73.58781
  • Kashiwa, Chiba, Japan|35.86224,139.97732

Key Eligibility Criteria

  • Male or female patients age ≥ 18 years.
  • Patients with one of the following histologically or cytologically confirmed and documented malignancies who have progressed on or been intolerant …
  • Dose Escalation:
  • Advanced HER2+ breast cancer with disease progression after at least two prior lines of systemic therapy in the advanced setting

For full eligibility, visit ClinicalTrials.gov.

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