Phase I Study of [177Lu]Lu-DFC413 in Patients With Solid Tumors

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07261631
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • 68Ga-NNS309 — DRUG
    Diagnostic investigational radiopharmaceutical
  • 177Lu-DFC413 — DRUG
    Therapeutic investigational radiopharmaceutical

Study Details

The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of \[177Lu\]Lu-DFC413 and safety and imaging properties of \[68Ga\]Ga-NNS309 in patients aged ≥ 18 years with solid tumors

Key Dates

First listed
Dec 3, 2025
Start date
Nov 24, 2025
Status verified
Jun 2026
Primary completion
May 9, 2029
Completion
May 9, 2029

Study Design

Enrollment
180 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Patients will receive 68Ga-NNS309 and only patients with tumor uptake will receive 177Lu-DFC413

Primary Outcome Measure

Incidence and severity of dose limiting toxicities of 177Lu-DFC413 [ Time Frame: Within first treatment cycle, up to maximum 6 weeks ]

Central Contacts

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