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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1 (Dosimetry) 		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.
  • Drug: SPLIT Abs
    Participants will receive SPLIT Abs as part of the pretargeting regimen per the schedule described in the protocol.
    Other names:
    • RO7782304
    • RO7782306
  • Drug: 203Pb-DOTAM
    Participants will receive 203Pb-DOTAM as an imaging surrogate per the schedule described in the protocol.
    Other names:
    • RO7205834-009
  • Drug: 212Pb-DOTAM
    Participants will receive 212Pb-DOTAM as a therapeutic radioligand per the schedule described in the protocol.
    Other names:
    • RO7205834-010
Experimental
Part 2 (212Pb-DOTAM Administered Activity Escalation) 		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).
  • Drug: SPLIT Abs
    Participants will receive SPLIT Abs as part of the pretargeting regimen per the schedule described in the protocol.
    Other names:
    • RO7782304
    • RO7782306
  • Drug: 203Pb-DOTAM
    Participants will receive 203Pb-DOTAM as an imaging surrogate per the schedule described in the protocol.
    Other names:
    • RO7205834-009
  • Drug: 212Pb-DOTAM
    Participants will receive 212Pb-DOTAM as a therapeutic radioligand per the schedule described in the protocol.
    Other names:
    • RO7205834-010
Experimental
Part 3 (Expansion) 		Participants will receive SPLIT Abs in combination with 212Pb-DOTAM at the RP2A identified based on results from Parts 1 and 2.
  • Drug: SPLIT Abs
    Participants will receive SPLIT Abs as part of the pretargeting regimen per the schedule described in the protocol.
    Other names:
    • RO7782304
    • RO7782306
  • Drug: 212Pb-DOTAM
    Participants will receive 212Pb-DOTAM as a therapeutic radioligand per the schedule described in the protocol.
    Other names:
    • RO7205834-010

Recruiting Locations

Nebraska Cancer Specialists
Omaha, Nebraska 68130

More Details

Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

Reference Study ID Number: BP45930 https://forpatients.roche.com/
888-662-6728 (U.S. and Canada)
global-roche-genentech-trials@gene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.