A Study to Assess Safety, Tolerability and Imaging Characteristics of [68Ga]Ga-DPI-4452 and to Assess Safety, Tolerability, and Efficacy of [177Lu]Lu-DPI-4452 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors

Recruiting Phase 1 Phase 2 Interventional Study
Clear Cell Renal Cell Cancer (ccRCC) Pancreatic Ductal Adenocarcinoma (PDAC) Colorectal Cancer (CRC) Urothelial Carcinoma (UC) Indeterminate Renal Mass (IDRM) Muscle Invasive Bladder Cancer (MIBC) Head and Neck Cancer (H&N) Triple Negative Breast Cancer (TNBC) Squamous Non-Small Cell Lung Cancer (NSCLC)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
270 (estimated)
Sponsor
Lumara Bio Oncologics GmbH · Industry
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About This Trial
The main purpose of Part A of the study is to evaluate safety, tolerability and tracer uptake after a single intravenous (IV) administration of \[68Ga\]Ga-DPI-4452 for each tumor type such as clear cell renal cell cancer (ccRCC), pancreatic ductal adenocarcinoma (PDAC), and colorectal cancer (CRC); Part B: is to determine the recommended phase 2 dose (RP2D) \[maximum tolerated dose (MTD) or lower …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: Part A, B, and C: * Written informed consent, dated and signed by the patient prior to any study-specific procedure. * Part B and C are not conducted in the United States of America. * Has histologically or cytologically confirmed, unresectable locally advanced or metastatic so…
Contacts

Lumara Bio Oncologics GmbH

(+49) 89 329898 66000

info-itm91_94-phase1_2@itm-radiopharma.com

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