700 Participants Needed

Bevacizumab + INCA33890 for Colorectal Cancer

Recruiting at 196 trial locations
IC
IC
Overseen ByIncyte Corporation Call Center (ex-US)
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Incyte Corporation
Must be taking: Chemotherapy, Bevacizumab
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of treatments to determine if it outperforms the standard approach for individuals with previously untreated metastatic colorectal cancer. The trial adds a new drug, INCA33890 (an experimental treatment), to the usual chemotherapy and bevacizumab (a targeted therapy) to assess improvement in results. Participants will receive either this new combination or a placebo with the standard treatment. Suitable candidates have stage IV colorectal cancer that cannot be surgically removed and have not yet undergone chemotherapy for their metastatic disease. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.

Do I have to stop taking my current medications for this trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that INCA33890 has been studied for its effects and safety. In one study, 105 patients received only INCA33890, and about 15% experienced a partial response, meaning their cancer shrank somewhat. However, the study did not provide specific details about safety or side effects.

Bevacizumab is a well-known treatment often used for various cancers. The FDA has approved it for treating some cancers, indicating it is generally safe when used correctly. Bevacizumab can have side effects, but these are usually known and managed in clinical settings.

The current trial tests a combination of INCA33890, bevacizumab, and a standard chemotherapy treatment called FOLFOX. Since this trial is in a later stage, earlier studies likely found the combination safe enough to test on more people. However, specific safety details for the combination are not provided in the sources.12345

Why are researchers excited about this trial's treatments?

Unlike the standard treatment for colorectal cancer, which typically includes chemotherapy regimens like FOLFOX, the investigational drug INCA33890 works differently by being combined with bevacizumab, an antibody that targets blood vessel growth in tumors. Researchers are excited about INCA33890 because it may enhance the effectiveness of bevacizumab and FOLFOX by adding a novel mechanism that targets specific pathways in cancer cells, potentially leading to improved outcomes. This unique combination could offer a more powerful approach against tumors, addressing the tough-to-treat aspects of colorectal cancer.

What evidence suggests that this trial's treatments could be effective for colorectal cancer?

Research shows that bevacizumab, when combined with standard chemotherapy like FOLFOX, can slow colorectal cancer growth by cutting off the blood supply tumors need. In this trial, one group of participants will receive INCA33890 alongside bevacizumab and FOLFOX. Studies have found that INCA33890, a new drug, targets specific proteins that aid tumor growth. In earlier research, 15.2% of patients who took INCA33890 alone experienced tumor shrinkage. Although specific data on using INCA33890 with bevacizumab for colorectal cancer is not yet available, its mechanism suggests potential benefits. This combination aims to enhance the effects of chemotherapy and bevacizumab, potentially offering a new treatment option.12367

Who Is on the Research Team?

IM

Incyte Medical Monitor

Principal Investigator

Incyte Corporation

Are You a Good Fit for This Trial?

This trial is for adults with stage IV colorectal cancer that can't be surgically removed. They should have measurable disease, be relatively active and well (ECOG 0 or 1), and not have had previous treatments for advanced cancer. If they've had adjuvant therapy, there must be no recurrence within a year.

Inclusion Criteria

My organ functions are within normal ranges according to recent tests.
My colorectal cancer is at stage IV and cannot be surgically removed.
I haven't had systemic treatment for my advanced cancer, and if I had adjuvant or neoadjuvant therapy, I've been recurrence-free for 12 months.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard-of-care chemotherapy and bevacizumab with or without INCA33890

Up to 3 years
Regular visits as per protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 4 years

What Are the Treatments Tested in This Trial?

Interventions

  • Bevacizumab
  • FOLFOX
  • INCA33890

Trial Overview

The study tests if adding INCA33890 to standard chemotherapy (FOLFOX) and Bevacizumab improves outcomes in first-line treatment of metastatic microsatellite stable colorectal cancer. Participants will either receive the new combination or the standard treatment plus a placebo.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: INCA33890Experimental Treatment3 Interventions
Group II: PlaceboPlacebo Group3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Incyte Corporation

Lead Sponsor

Trials
408
Recruited
66,800+
Steven Stein profile image

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot profile image

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School

Citations

Baseline biomarker analysis and clinical outcomes of the ...

Results: As of July 25, 2025, efficacy data with INCA33890 monotherapy were available from 105 pts; 16 pts (15.2%) had a partial response (PR), ...

Baseline Biomarker Analysis and Clinical Outcomes of the ...

Results:As of July 25, 2025, efficacy data with INCA33890 monotherapy were available from 105 pts; 16 pts (15.2%) had a partial response (PR), ...

Incyte Announces Phase 1 Results for its TGFβR2×PD-1 ...

“Increased TGFβR2 expression is associated with poor prognosis in multiple solid tumor types, including colorectal cancer, which is third most.

Baseline biomarker analysis and clinical outcomes of the ...

Results: As of July 25, 2025, efficacy data with INCA33890 ... No data are available concerning patients (pts) with metastatic colorectal cancer ...

NCT07284849 | A Study to Evaluate the Efficacy and ...

The purpose of this study is to evaluate the efficacy and safety of standard-of-care chemotherapy and bevacizumab with or without INCA33890 in the ...

A Study to Evaluate the Safety of INCA33890 ...

"Within this cohort, 16 patients treated with INCA33890 responded (14 confirmed), with 15.2% achieving an objective response rate (ORR) and a median ...

Study to evaluate the efficacy and safety of the new drug ...

Summary description of the study. In this study, we evaluate the efficacy of the tested substance, INCA33890, and we check whether it is effective, ...