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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

ConditionsClear 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)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLumara Bio Oncologics GmbH

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) \[maximum tolerated dose (MTD) or lower dose\] for \[177Lu\]Lu-DPI-4452 for each tumor type such as ccRCC, PDAC, CRC, and urothelial carcinoma (UC); Part C: is to evaluate the preliminary antitumor activity of \[177Lu\]Lu-DPI-4452 as monotherapy for each tumor type such as ccRCC, PDAC, CRC, and UC; Part D: is to assess the diagnostic concordance between \[68Ga\]Ga-DPI-4452 Positron Emission Tomography (PET) and the histopathology result of the Indeterminate Renal Mass (IDRM); Part E: is to assess \[68Ga\]Ga-DPI-4452 uptake in each tumour type such as UC, muscle invasive bladder cancer (MIBC), head and neck cancer (H\&N), triple negative breast cancer (TNBC), squamous non-small cell lung cancer (NSCLC), and any other tumor with locally confirmed carbonic anhydrase (CA) IX expression except ccRCC, CRC and PDAC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Clear cell renal cell cancer (ccRCC) - participants must have received at least one line containing Tyrosine kinase inhibitor (TKI) treatment and at least one line containing immune checkpoint inhibitor treatment in metastatic setting, meaning at least two lines of treatment in metastatic setting.

Pancreatic ductal adenocarcinoma (PDAC) - participants must have received at least one line of platinum- and/or gemcitabine-based regimen.

Disqualifiers

Any major surgery within 12 weeks before enrolment.

Inability to stay in the scanner bed with the arms resting out of the thoracic and abdominal fields (i.e., arms alongside the body or raised arm position) for the duration of the scan.

Has known hypersensitivity to the active substance, to any of the excipients of the DPI-4452, or to radiographic contrast agents.

Bladder outflow obstruction or unmanageable urinary incontinence.

Trial design

Design model

Sequential

Treatments tested in this trial

  • [68Ga]Ga-DPI-4452

    Drug

    \[68Ga\]Ga-DPI-4452, administered as IV injection.

  • [177Lu]Lu-DPI-4452

    Drug

    \[177Lu\]Lu-DPI-4452, administered as IV infusion.

Treatment groups

270 Participants
are divided into 5 treatment groups
Group A: Part A: [68Ga]Ga-DPI-4452Experimental treatment 1 intervention
Group B: Part B: [177Lu]Lu-DPI-4452Experimental treatment 2 interventions
Group C: Part C: [177Lu]Lu-DPI-4452Experimental treatment 2 interventions
Group D: Part D: [68Ga]Ga-DPI-4452Experimental treatment 1 intervention
Group E: Part E: [68Ga]Ga-DPI-4452Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part A: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Time frame
Up to Day 7
2

Part B: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)

Time frame
Cycle 1(each cycle = 28 or 42 days depending on every 4 weeks or 6 weeks dosing schedule)
3

Part C: Objective Response Rate (ORR)

Time frame
Up to 81 months
4

Part D: Concordance Between [68Ga]Ga-DPI-4452 Uptake by PET Imaging and Assessment of Histological Characteristics of IDRM

Time frame
Day 1

Secondary outcomes

1

Part A, B, and C: Concentration of [68Ga]Ga-DPI-4452 and [177Lu]Lu-DPI-4452 in Blood and Plasma

Pharmacokinetics (PK) will be evaluated in blood and plasma for radioactivity of \[68Ga\]Ga-DPI-4452 and \[177Lu\]Lu-DPI-4452.

Time frame
Part A: Pre-dose and at multiple time points up to 4 hours post-dose on Day 1; Parts B and C: Pre-dose and at multiple time points up to 72 hours post-dose of Cycles 1, 2 and 3 (84 days) (each cycle = 28 or 42 days depending on every 4 weeks or 6 weeks)
2

Parts A, B, and C: Concentration of [68Ga]Ga-DPI-4452 and [177Lu]Lu-DPI-4452 in Urine

PK will be evaluated in urine for radioactivity of \[68Ga\]Ga-DPI-4452 and \[177Lu\]Lu-DPI-4452.

Time frame
Part A: Pre-dose and at multiple time points up to 4 hours post-dose on Day 1; Parts B and C: Pre-dose and at multiple time points up to 48 hours post-dose of Cycle 1 (each cycle = 28 or 42 days depending on every 4 weeks or 6 weeks dosing schedule)
3

Part A: Radioligand [68Ga]Ga-DPI-4452 PET Scan Time-Window for Optimal Imaging

Time frame
Day 1
4

Part B: Objective Response Rate (ORR)

Time frame
Up to 81 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lumara Bio Oncologics GmbH

Lead sponsor

Source ClinicalTrials.gov
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