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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-523322-40-00 | EU Trial (CTIS) Number |
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This study will evaluate the dosimetry, safety, efficacy, pharmacokinetics (PK), pharmacodynamics and immunogenicity of CEA-PRIT 2.0 in participants with metastatic microsatellite-stable (MSS) mCRC who are intolerant to or have progressed after having received available standard-of-care (SOC) therapies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 (Dosimetry) | Experimental | Participants will receive SeParated v-domains LInkage Technology Antibodies (SPLIT Abs) administered intravenously (IV). During Cycle 1, following an initial dosing interval, participants will receive 203Pb-DOTAM for imaging-based dosimetry assessment, followed by administration of 212Pb-DOTAM. In other cycles, participants will receive SPLIT Abs in combination with 212Pb-DOTAM only. Treatment will be administered every 4 weeks (Q4W) for up to 6 cycles. Each cycle is 28 days. |
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| Part 2 (212Pb-DOTAM Administered Activity Escalation) | Experimental | Participants will receive SPLIT Abs at the dose and dosing interval selected in Part 1 in combination with 212Pb-DOTAM. The administered activity of 212Pb-DOTAM will be increased stepwise in each cohort to identify the maximum tolerated administered 212 activity (MTA) or a recommended Phase 2 administered activity (RP2A). |
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| Part 3 (Expansion) | Experimental | Participants will receive SPLIT Abs in combination with 212Pb-DOTAM at the RP2A identified based on results from Parts 1 and 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPLIT Abs | Drug | Participants will receive SPLIT Abs as part of the pretargeting regimen per the schedule described in the protocol. |
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| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Serum Concentration of SPLIT Abs | Up to approximately 48 weeks | |
| Part 1: Time Course of Blood, Plasma, and Urine Radioactivity for 203Pb-DOTAM | Up to approximately 48 weeks | |
| Part 1 to 2: Absorbed Radiation Dose of 212Pb-DOTAM extrapolated from 203Pb-DOTAM | Up to approximately 48 weeks | |
| Part 1 to 3: Percentage of Participants With Adverse Events (AE) | Up to approximately 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 to 2: Uptake of 203Pb-DOTAM in Tumor and Normal Tissue | Up to approximately 48 weeks | |
| Part 1 to 2: Time Course of Blood, Plasma, and Urine Radioactivity for 203Pb-DOTAM | Up to approximately 48 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: BP45930 https://forpatients.roche.com/ No attachments to email below. | Contact | 888-662-6728 (U.S. and Canada) | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nebraska Cancer Specialists | Omaha | Nebraska | 68130 | United States |
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| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| 203Pb-DOTAM | Drug | Participants will receive 203Pb-DOTAM as an imaging surrogate per the schedule described in the protocol. |
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| 212Pb-DOTAM | Drug | Participants will receive 212Pb-DOTAM as a therapeutic radioligand per the schedule described in the protocol. |
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| Part 1 to 3: Serum Concentration of CEA-PRIT 2.0 | Up to approximately 48 weeks |
| Part 1 to 3: Time Course of Blood and Plasma Radioactivity for 212Pb-DOTAM | Up to approximately 48 weeks |
| Part 1 to 3: Percentage of Participants With Anti-Drug Antibodies (ADAs) Against SPLIT Abs | Baseline, Up to approximately 48 weeks |
| Part 1 to 3: Objective Response Rate (ORR) | Up to approximately 48 weeks |
| Part 1 to 3: Disease Control Rate (DCR) | Up to approximately 48 weeks |
| Part 1 to 3: Duration of Response (DOR) | Up to approximately 48 weeks |
| Part 1 to 3: Progression-Free Survival (PFS) | Up to approximately 48 weeks |
| Part 1 to 3: Overall Survival (OS) | Up to approximately 48 weeks |
| Part 1 to 3: Correlation Between Carcinoembryogenic Antigen (CEA) Tumor Expression and Clinical Activity | Up to approximately 48 weeks |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |