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New combo therapy targets colorectal cancer in Mid-Stage trial

NCT ID NCT07071714

Disease control Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 12, 2026 · Updated 2 times

Summary

This study tests a new drug called SHR-8068 combined with other cancer treatments for people with colorectal cancer. The goal is to see if the combination is safe and helps shrink tumors or slow cancer growth. About 200 adults aged 18 to 75 will take part, and they must provide tumor samples for genetic testing.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

103 people

The number who actually took part.

Started

Jul 2025

Expected to finish

Oct 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 75 years

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: 1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form. 2. Male or female ≥ 18 years old and ≤75 years old. 3. ECOG performance status of 0-1. 4. Part A with a life expectancy of ≥2 years. Part B with a life expectancy of ≥12 weeks. 5. Need to provided tumor tissue samples for genetic testing. Exclusion Criteria: 1. Part B: Accompanied by untreated or active central nervous system (CNS) metastases. Subjects with a history or current history of meningeal metastasis. 2. Part B: Systemic antitumor therapy was received 4 weeks before the start of the study. 3. Part B: Palliative radiotherapy was completed within 14 days before the first dose. 4. Toxicity and/or complications from previous interventions did not return to NCI-CTCAE level ≤1 or exclusion criteria. 5. Subjects with known or suspected interstitial pneumonia. 6. Moderate or severe ascites with clinical symptoms; Uncontrolled or moderate or higher pleural effusion or pericardial effusion. 7. Have poorly controlled or severe cardiovascular disease. 8. Subjects with active hepatitis B or active hepatitis C. 9. A history of immunodeficiency, including a positive HIV test, other acquired or congenital immunodeficiency disorders, or a history of organ transplantation. 10. The presence of uncontrolled mental illness and other conditions known to affect the completion of the study process, such as alcohol, drug or substance abuse, and criminal detention. 11. Any other factors that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate as judged by investigators.

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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

  • The Sixth Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510655, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.