Recruiting PHASE2 Metastatic Colorectal Cancer

New treatment option for Metastatic Colorectal Cancer

Official title Evaluation of RBS2418 in Patients With Advanced, Metastatic, and Progressive Colorectal Cancer

ClinicalTrials.gov ID: NCT06824064

What this study is testing

What is RBS2418?

RBS2418 is an investigational medicine, being studied as a potential treatment for metastatic colorectal cancer.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
RBS2418 is a specific immune modulator that works through the inhibition of ectonucleotide pyrophosphatase/phosphodiesterase 1 (ENPP1) and is designed to lead to anti-tumor immunity by protecting endogenous 2'-3'-cyclic guanosine monophosphate-adenosine monophosphate (cGAMP) from hydrolysis and leading to the activation of antigen-presenting cells followed by T cell activation. The hypothesis is that RBS2418 versus placebo will be generally safe, well-tolerated, immunogenic, and will lead to anti-tumor responses in adult subjects for the treatment of advanced, metastatic, and progressive colorectal cancer (CRC).
  • Phase 2: a mid-size study of how well it works
  • You might receive a placebo (an inactive treatment) instead of the study drug.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • At least 18 years of age on the day of signing informed consent.
  • Male and female people with advanced, metastatic, progressive CRC who have received, been ineligible for, intolerant to, or declined all approved...
  • Have histologically or cytologically confirmed CRC diagnosis based on pathology report.
  • Willing to submit a pre-treatment tissue sample (archival, or fresh tissue if archival is not available).

You likely can't join if

  • Any approved anti-cancer therapy including chemotherapy, targeted small molecule therapy, systemic immunotherapy, or radiation therapy within 2 weeks...
  • Palliative radiotherapy for bone metastases or soft tissue lesions should be completed \>7 days prior to the first dose of study treatment.
  • Hormone-replacement therapy or oral contraceptives.
  • people with Grade 2 neuropathy or Grade 2 alopecia.
  • people with evidence of rapid progression on prior therapy resulting in rapid clinical deterioration.
  • Malignancies other than indications open for enrollment within 3 years prior to Day 1, except for those with negligible risk of metastasis or death...

The study team makes the final eligibility decision.

Where it's taking place

  • Newark, Delaware, United States
  • Kingwood, Texas, United States
  • San Juan, Puerto Rico
  • Ho Chi Minh City, Ho Chi Minh City, Vietnam
  • Hà Nội, Vietnam

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Newark, Delaware, United States; Kingwood, Texas, United States; San Juan, Puerto Rico; Ho Chi Minh City, Ho Chi Minh City, Vietnam; Hà Nội, Vietnam. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.