RightFit
RecruitingPhase 1

A Study to Investigate CEA-PRIT 2.0 in Participants With Metastatic Colorectal Cancer (mCRC)

A Phase I, Open-Label, Escalation and Expansion Study to Evaluate Dosimetry, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of CEA-Pre-Targeted 212Pb Therapy in Participants With Metastatic Colorectal Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests CEA-PRIT 2.0 for colon or rectal cancer that has spread and has a gene-repair feature called MSS. It looks at radiation dose, safety, how well the treatment works, and how the body responds. It is for people whose cancer got worse after standard treatments or who could not tolerate them.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • A tissue test shows adenocarcinoma, a cancer that starts in gland cells, in the colon or rectum.
  • The cancer has spread to other parts of the body (stage IV).
  • Tests show MSS and/or working mismatch repair, features related to how cancer cells repair DNA.
  • The cancer got worse during treatment for cancer that had spread, or within 3 months after the last dose.
  • The cancer can be measured using the study’s rules.
  • The study doctor expects you to live at least 12 weeks.
  • You can do all usual activities or have trouble only with hard physical activity.
  • Your heart, blood, and kidneys work well enough, and your lab results meet study rules.

Who can't join

  • You are pregnant, breastfeeding, or planning to become pregnant.
  • You have active cancer spread to the brain or spinal cord, or a history of another cancer.
  • You still have side effects from earlier cancer treatment or surgery.
  • You had major surgery or a serious injury less than 4 weeks before the first study dose, or expect to need major surgery during treatment. Biopsies do not count.
  • You have a confirmed positive HIV test.
  • Screening tests are positive for hepatitis B surface antigen, hepatitis B core antibodies, or hepatitis C antibodies.
  • You received cancer treatment or an experimental drug too recently before the first study dose: within 4 weeks, or 5 times the drug’s half-life, whichever is shorter. Half-life is the time for half the drug to leave the body.
  • You previously received treatment aimed at CEA, a cancer-related protein, or radiation treatment that travels through the body.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (5)

IL

MO

NE

TX

WI