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New hope for Hard-to-Treat colorectal cancer: targeted combo trial launches

NCT ID NCT06838338

Disease control Sponsor: Jian Li Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tests a new drug called JAB-21822, which targets a specific genetic mutation (KRAS G12C), combined with standard chemotherapy and bevacizumab. The study includes 30 Chinese patients with advanced colorectal cancer that has not responded to first-line treatment. The goal is to see if this combination can shrink tumors and improve survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
JAB-21822 (a KRAS G12C inhibitor) combined with standard second-line chemotherapy (FOLFIRI or FOLFOX) and bevacizumab
What this could lead to
If successful, this could offer a new treatment option for Chinese patients with KRAS G12C colorectal cancer who have run out of standard options.
What could go wrong
This is a very early Phase 1 trial with only 30 participants, so safety and effectiveness are not yet proven. The combination may cause significant side effects or fail to shrink tumors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically (or cytologically) confirmed, unresectable metastatic colorectal cancer. * KRAS G12C mutation. * At least one measurable disease per RECIST v1.1; assessed within 28 days before first dose. * Subject have withdrawn from the first-line chemotherapy due to disease progression or unacceptable toxicity; if first-line chemotherapy and maintenance therapy were received, disease progression must within three months; first-line chemotherapy regimens do not limit the use of antiangiogenic agents. * Adequate bone marrow, liver and renal function. * ECOG performance status 0-1. * Informed consent has been signed. Exclusion Criteria: * Patients have received KRAS G12C inhibitors. * Patients have received a first-line treatment, which include fluoropyrimidine, oxaliplatin and irinotecan. * Patients who are pregnant or breastfeeding. * Life expectancy of less than 3 months. * Patients who had major surgery or significant trauma within 4 weeks prior to the first blood sample collection during the screening period, or expected to require major surgery during the study period. * Patients with active ulcers and gastrointestinal bleeding. * Prior history of interstitial lung disease or non-infectious pneumonia; history of active tuberculosis. * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage. * Patients with clinically diagnosed autoimmune disease; HIV, HCV positive; HBV-DNA beyond the normal range of the laboratory; Acute CMV infection. * Patients with active central nervous system metastases requiring treatment. * Patients with other malignancies within five years. * Assessed by the investigator, patients who are unable or unwilling to comply with the requirements of the study protocol.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal cancer

Contacts and locations

Locations

  • Beijing Cancer Hospital

    Beijing, China

  • Fudan University Shanghai Cancer Center

    Shanghai, China

  • Peking University Cancer Hospital (Inner Mongolia Campus)/Afffliated Cancer Hospital of Inner Mongolia Medical University

    Hohhot, China

  • Peking University First Hospital

    Beijing, China

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