89Zr-olaratumab Dosimetry in Participants With PDGFR Alpha Positive Solid Tumours and Soft Tissue Sarcoma

Sponsor
Telix Pharmaceuticals (Innovations) Pty Ltd
Study ID
NCT06537596
Phase
PHASE1
Status
Recruiting
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Conditions

  • PDGFR Alpha Positive Solid Tumours
  • Soft Tissue Sarcoma

Eligibility Criteria

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

Interventions

  • 89Zr-DFOsq-olaratumab (89Zr-TLX300-CDx) — DRUG
    Single administration of 89Zr-TLX300-CDx

Study Details

Soft Tissue Sarcoma (STS) is a cancer of soft tissues that often expresses Platelet-Derived Growth Factor Receptor (PDGFR)α, a potential therapeutic target. PDGFRα is also found in other advanced solid tumours. Olaratumab, a PDGFRα-targeted antibody, may be used to deliver radioactive isotopes for imaging or therapy. This first-in-human study will evaluate zirconium-89-labelled olaratumab (⁸⁹Zr-TLX300-CDx) for imaging in patients with STS, selected PDGFRα-positive solid tumours and identification of patients that may benefit from future treatments.

Key Dates

First listed
Aug 5, 2024
Start date
Oct 31, 2024
Status verified
Aug 2026
Primary completion
Oct 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Part A
    One Injection of 89Zr-TLX300-CDx
  • Experimental: Part B
    One Injection of 89Zr-TLX300-CDx
  • Experimental: Part C
    One Injection of 89Zr-TLX300-CDx

Primary Outcome Measure

Evaluate clinical safety and tolerability of 89Zr-TLX300-CDx [ Time Frame: 30 days ]

Central Contacts

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