RightFit
RecruitingPhase 3

A Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine/Tipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)

A Randomized, Open Label, 3-arm Phase 3 Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine/Tipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)

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 is for people with colon or rectal cancer that has spread and was already treated with irinotecan, oxaliplatin, a fluoropyrimidine, and bevacizumab. It tests whether precemtabart tocentecan, alone or with bevacizumab, helps people live longer than trifluridine/tipiracil plus bevacizumab.

This study aims to address the unmet medical need of participants with metastatic colorectal cancer (mCRC) who have previously been treated with irinotecan, oxaliplatin, a fluoropyrimidine, and bevacizumab, by demonstrating an overall survival prolongation with precemtabart tocentecan (Precem-TcT) as single agent or Precem-TcT in combination with bevacizumab compared to trifluridine/tipiracil (FTD-TPI) plus bevacizumab.

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

Eligibility

Who can join

  • Have colon or rectal cancer that has spread, confirmed by a tissue test.
  • Standard cancer treatments did not work, stopped working, or caused side effects you could not tolerate.
  • Have had no more than 2 treatment plans for cancer that has spread, and the cancer got worse after treatment.
  • Be fully active or able to walk and do light work, even if you cannot do hard physical activity.
  • Be able to swallow tablets and follow study rules, including all planned health checks.
  • Other study rules may apply.

Who can't join

  • Side effects from past treatments have not improved to below grade 1 on a medical rating scale.
  • Have had another cancer within 3 years before being assigned to a study group.
  • Have cancer known to have spread to the brain.
  • Within the past 6 months, have had an abnormal opening in the belly, a hole in the stomach or bowel, or a pocket of infection inside the belly.
  • Have more than mild slowing or stopping of bowel movement, or a blocked bowel.
  • Have long-term bowel inflammation, such as ulcerative colitis or Crohn’s disease.
  • Have a long-term digestive problem that the study doctor thinks could greatly affect how your body takes in the study drugs.
  • Other study rules may apply.

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

Official eligibility criteria

Inclusion Criteria: * Participants with documented histopathological diagnosis of metastatic colorectal cancer, who were intolerant to, or whose disease was refractory to, or progressed after standard systemic therapies and no more than 2 previous systemic treatment regimens in the metastatic setting. * Participants must have received and progressed on no more than 2 previous systemic treatment regimens in the metastatic setting * Eastern Cooperative Oncology Group (ECOG) performance status less than equal to 1 * Participants must be able to swallow oral tablets, and to comply with the study requirements for all scheduled evaluations * Other protocol defined inclusion criteria may apply Exclusion Criteria: * If Adverse Events related to previous therapies have not recovered to less than Grade 1 by National Cancer Institute - Common Terminology Criteria for Adverse Events version 6.0 * Participant has a history of additional malignancy within 3 years before randomization * Participants with known brain metastases * Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months prior to randomization * Participants with ileus of more than Grade 1, or chronic inflammatory bowel disease (example ulcerative colitis, Crohn's disease) and/or bowel obstruction, or participants with chronic gastrointestinal disorders that, in the Investigator's opinion, might significantly interfere with proper absorption of the study treatments * Other protocol defined exclusion criteria may apply

Study sites (19)

CO

FL

IL

MI

MN

MO

NY

TN

TX

VA