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

Part of paid clinical trials in Omaha, Nebraska.

Sponsor: Novartis Pharmaceuticals
Study ID: NCT07660055
Phase: PHASE1
Status: Recruiting

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Conditions

Bladder Cancer
Breast Cancer
Gastric/Gastroesophageal Junction (GEJ) Cancer
Non-small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
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: Aug 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.