Metastatic Colorectal Cancer
Conditions
Brief summary
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.
Interventions
DRUGSPLIT Abs
Participants will receive SPLIT Abs as part of the pretargeting regimen per the schedule described in the protocol.
DRUG203Pb-DOTAM
Participants will receive 203Pb-DOTAM as an imaging surrogate per the schedule described in the protocol.
DRUG212Pb-DOTAM
Participants will receive 212Pb-DOTAM as a therapeutic radioligand per the schedule described in the protocol.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed adenocarcinoma originating from the colon or rectum * Metastatic disease (Stage IV American Joint Committee on Cancer, Version 7) * Confirmed MSS and/or proficient mismatch repair (MMR) status * Experienced disease progression during or within 3 months following the last administration of systemic anti-cancer therapies for metastatic disease * Presence of measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. * Life expectancy estimated by the Investigator to be \>=12 weeks * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1 * Adequate cardiovascular, hematological and renal function and laboratory parameters
Exclusion criteria
* Pregnant or breastfeeding or intending to become pregnant * Participants with active central nervous system (CNS) metastases * History of malignancy other than the one under investigation * Any unresolved toxicities from prior therapy, i.e., radiotherapy, chemotherapy, targeted therapy or surgical procedure * Major surgery or significant traumatic injury \<4 weeks prior to the first CEA-PRIT 2.0 administration (excluding biopsies) or anticipation of the need for major surgery during study treatment * Participants have a known confirmed positive test for HIV * Positive hepatitis B surface antigen (HBsAg) test, and/or positive total hepatitis B core Ab (HBcAb) test at screening. * Positive hepatitis C (HCV) Ab test result at screening * Any anticancer treatment or any investigational agent within 4 weeks (or 5 times the half-life, whichever is shorter) prior to C1D1 * Prior treatment with a CEA-targeted agent or systemic radio therapy
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
| 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 |
Countries
United States
Contacts
CONTACTReference Study ID Number: BP45930 https://forpatients.roche.com/ No attachments to email below.
CONTACTFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed