Safety and Tolerability of ²¹²Pb-DOTAM-GRPR1 in Adult Subjects With Recurrent or Metastatic GRPR-expressing Tumors

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Orano Med Theranostics, SAS
Study ID
NCT05283330
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • ²¹²Pb-DOTAM-GRPR1 — DRUG
    ²¹²Pb-DOTAM-GRPR1 is a radioimmunoconjugate comprised of ²¹²Pb, the metal chelator DOTAM (1,4,7,10-Tetrakis(carbamoylmethyl)-1,4,7,10- tetraazacyclododecane) and a GRPR-targeted antagonist.

Study Details

A Phase 1 Open-Label, First-in-human, Dose Escalation and Expansion Study to Determine the Safety, Tolerability, Dosimetry, Pharmacokinetics, and Preliminary Efficacy of 212Pb-DOTAM-GRPR1 in Adult Participants with Recurrent or Metastatic GRPR-expressing Tumors

Key Dates

Start date
Dec 22, 2022
Status verified
Jun 2026
Primary completion
Jan 31, 2027
Completion
May 31, 2032

Study Design

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

Arms

  • Experimental: ²¹²Pb-DOTAM-GRPR1
    In the dose escalation portion, a classic 3+3 design will be utilized for the SAD cohorts and a Boin design for the MAD cohorts. Doses will be increased by approximately 30% in subsequent cohorts. The maximum total dose that may be administered to a subject per cycle is 5.5 mCi +/- 10%.

Primary Outcome Measure

To determine the Recommended Phase 2 Dose (RP2D) of ²¹²Pb-DOTAM-GRPR1 [ Time Frame: 14 months ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Northwestern University Robert H Lurie Medical ResearchChicagoIllinois60611-
University of Iowa Health CareIowa CityIowa52242
David Bushness, MD (PRINCIPAL_INVESTIGATOR)
UK Markey Cancer CenterLexingtonKentucky40536
859-323-7628
Eddy Yang, MD (PRINCIPAL_INVESTIGATOR)
Advanced Molecular Imaging and TherapyGlen BurnieMaryland21061
443-333-1894
Michael Morris, MD (PRINCIPAL_INVESTIGATOR)
United Theranostics - ChesapeakeGlen BurnieMaryland21061
Babak Saboury, MD (PRINCIPAL_INVESTIGATOR)
Nebraska Cancer Specialists (Midwest Cancer Center - Legacy)OmahaNebraska68130
Samuel Mehr, MD (PRINCIPAL_INVESTIGATOR)
XCancer Omaha / Urology Cancer CenterOmahaNebraska68130
402-697-2229
Luke Nordquist, MD (PRINCIPAL_INVESTIGATOR)
University of Pittsburg Medical Center (UPCM)PittsburghPennsylvania15219
Neeta Pandit Taskar, MD (PRINCIPAL_INVESTIGATOR)

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Northwestern University Robert H Lurie Medical Research· Chicago, ILUniversity of Iowa Health Care· Iowa City, IAUK Markey Cancer Center· Lexington, KYAdvanced Molecular Imaging and Therapy· Glen Burnie, MDUnited Theranostics - Chesapeake· Glen Burnie, MDNebraska Cancer Specialists (Midwest Cancer Center - Legacy)· Omaha, NE

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