Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can a new biologic drug shrink advanced melanoma tumors?

NCT ID NCT06081920

Disease control Sponsor: Innovent Biologics (Suzhou) Co. Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

This phase II trial is testing an experimental drug called IBI363 in people with advanced melanoma that has worsened after at least one prior treatment. The study aims to see whether IBI363 is safe and can shrink tumors or slow their growth. About 180 participants will receive IBI363 alone, and researchers will track side effects, tumor response, and how long any benefits last.

What this could mean

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

Active substance
an experimental biologic drug called IBI363
What this could lead to
If IBI363 proves safe and shrinks tumors, it could offer a new treatment option for advanced melanoma that has stopped responding to standard therapies.
What could go wrong
This is an early phase II trial with only 180 participants, so results may not apply broadly. IBI363 may cause side effects or fail to control the cancer.

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

About 180 people

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

Started

Oct 2023

Expected to finish

Oct 2028

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 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. Histologically and/or cytologically confirmed, unresectable, locally advanced or metastatic melanoma (according to the American Joint Committee on Cancer (AJCC) 8th edition staging III-IV). Progression or recurrence after at least first-line systemic standard treatment. 2. At least one measurable lesion (target lesion) per RECIST v1.1. 3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. 4. Life expectancy of 3 months or more. 5. Female subjects of childbearing age or male subjects whose partners are female subjects of childbearing age agree to strictly adopt effective contraceptive measures throughout the entire treatment period and 6 months after the treatment period. Exclusion Criteria: 1. Pregnant or lactating subjects, or subjects who plan to conceive before, during, or within 6 months after the last dose of the study drug. 2. Active or symptomatic central nervous system metastasis. 3. At baseline (within 7 days before the first administration of the study drug), there were any hematological abnormalities as follows: hemoglobin\<90 g/L; Absolute neutrophil count (ANC)\<1.5 × 109/L; Platelet count\<100 × 109/L. 4. At baseline (within 7 days prior to first administration), there were any serum biochemical abnormalities as follows: Total bilirubin\>1.5 × ULN; AST or ALT\>3 × ULN; If it is tumor liver metastasis, AST or ALT\>5.0 × ULN; Serum creatinine\>1.5 × ULN or CCr\<45 mL/min, using the Cockcroft Fault formula to calculate CCr (using actual body weight); Albumin\<30 g/L. 5. At baseline (within 7 days before first administration), there were any coagulation parameter abnormalities as follows: INR\>1.5 × ULN (\>3 if receiving anticoagulant therapy with stabilizer dosage) × ULN); PTT (or activated partial thromboplastin time (aPTT))\>1.5 × ULN (\>3 if receiving anticoagulant therapy with stabilizer dosage) × ULN). 6. History of active thrombosis, deep vein thrombosis, or pulmonary embolism within 4 weeks prior to the first administration of the investigational drug, unless sufficient treatment has been given and the investigator believes that the condition is stable. 7. Uncontrolled bleeding or known tendency to bleed.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Advanced melanoma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

melanoma metastatic melanoma

As listed by the trial registrant

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

Melanoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

  • Fujian Cancer Hospital

    RECRUITING

    Fuzhou, Fujian, 350000, China

  • Hunan Cancer Hospital

    RECRUITING

    Changsha, Hunan, 410031, China

  • Jilin Cancer Hospital

    RECRUITING

    Changchun, Jilin, 130012, China

  • Nanjing Drum Tower Hospital

    RECRUITING

    Nanjing, Jiangsu, 210000, China

  • Peking University Cancer Hospital & Institute, Beijing, China,

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

  • Qilu Hospital of Shandong university

    RECRUITING

    Jinan, Shandong, 250012, China

  • Shanxi Bethune Hospital

    RECRUITING

    Taiyuan, Shanxi, 030032, China

  • The Third people's hospital of Zhengzhou

    RECRUITING

    Zhengzhou, Henan, 450044, China

  • The first affiliated hospital of Nanchang university

    RECRUITING

    Nanchang, Jiangxi, 330052, China

  • The first hospital of Jilin University

    RECRUITING

    Changchun, Jilin, 130021, China

  • Yunan Cancer Hospital

    RECRUITING

    Kunming, Yunan, 650118, China

More trials for these conditions

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