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New drug aims to outsmart resistant colorectal cancer

NCT ID NCT05426005

Disease control Sponsor: Sun Yat-sen University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial tests a new drug called Cadonilimab in 28 people with advanced colorectal cancer that has not responded to standard immunotherapy. The drug is a bispecific antibody that targets two immune checkpoints (PD-1 and CTLA-4) to potentially reactivate the immune system against tumors. The main goal is to see how many patients have their tumors shrink or stop growing for at least 12 months.

What this could mean

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

Active substance
Cadonilimab (a bispecific antibody targeting PD-1 and CTLA-4)
What this could lead to
If successful, this could offer a new treatment option for people with advanced colorectal cancer whose tumors have stopped responding to current immunotherapies.
What could go wrong
This is an early-phase trial with only 28 participants, so results may not apply broadly. The drug may not work or could cause significant side effects.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 28 people

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

Started

Feb 2023

Expected to finish

Dec 2028

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: 1. Willing and able to provide written informed consent. 2. Histological or cytological documentation of adenocarcinoma of the colon or rectum. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 4. Tumor tissues were identified as mismatch repair-deficient (dMMR) by immunohistochemistry (IHC) method or microsatellite instability-high (MSI-H) by polymerase chain reaction (PCR). 5. Subjects with stage IV colorectal cancer must have measurable or non measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1. 6. Previous treatment with an anti-PD-1 or PD-L1 monoclonal antibody for advanced or metastatic colorectal cancer has failed. Treatment failure was defined as: disease progression or unacceptable toxicity during treatment or within 6 months after the last treatment. 7. Adequate bone marrow, liver and renal function as assessed by the laboratory required by protocol. Exclusion Criteria: 1. Previously received anti-cytotoxic T lymphocyte-associated antigen 4 (cytotoxic T-lymphocyte-associated Protein 4, CTLA-4) antibody. 2. Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment. 3. Heart failure grade III/IV (NYHA-classification). 4. Unresolved toxicity higher than CTCAE v.5.0 Grade 1 attributed to any prior therapy/procedure. 5. Subjects with known allergy to the study drugs or to any of its excipients. 6. Current or recent (within 4 weeks prior to starting study treatment) treatment of another investigational drug or participation in another investigational study. 7. Breast- feeding or pregnant women. 8. Lack of effective contraception.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm Lynch syndrome mismatch repair cancer syndrome 1 type 1 diabetes mellitus 12

As listed by the trial registrant

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

Colorectal cancer stage IV Microsatellite instability-high (msi-H) Mismatch repair-deficient (DMMR)

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.