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Can a Dual-Action drug outsmart advanced cancers?

NCT ID NCT05460767

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time

Summary

This early-stage trial is testing an experimental drug called IBI363 in people with advanced solid tumors or lymphoma that have progressed despite standard treatment. IBI363 is designed to boost the immune system in two ways: by stimulating immune cells with an IL-2-like signal and by blocking the PD-1 checkpoint that cancers use to hide. The study aims to find the safest dose and see whether the drug shows signs of shrinking tumors, with some participants also receiving bevacizumab.

What this could mean

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

Active substance
IBI363, a biologic that combines an IL-2 cytokine with an anti-PD-1 antibody, sometimes given with bevacizumab
What this could lead to
If successful, this could lead to a new treatment option for people with advanced cancers that have stopped responding to standard therapies.
What could go wrong
This is an early-phase trial, so the drug may not be effective or may cause significant side effects. The results will need confirmation in larger studies.

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

504 people

The number who actually took part.

Started

Aug 2022

Expected to finish

Jun 2027

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. Male or female subjects, ≥ 18 years 2. Histologically or cytologically confirmed, unresectable locally advanced or metastatic solid tumors or lymphomas 3. Subjects who progressed or are intolerant to existing standard therapy or subjects without standard therapy Note: Subjects may have received and failed prior therapy with a PD-1/PD-L1 inhibitor and be considered eligible for this trial. 4. Subjects with at least one measurable lesion according to RECIST v1.1 for solid tumor or Lugano 2014 for lymphoma 5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1. 6. Expected survival time ≥ 3 months. Exclusion Criteria: 1. Subjects with history of or known active seizure disorder, brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease. 2. Subjects with active thrombosis, or a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within 4 weeks prior to first administration of study drug unless adequately treated and considered by the Investigator to be stable. 3. Active uncontrolled bleeding or a known bleeding diathesis. 4. Subjects with massive pleural effusion or massive ascites.

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Conditions

The condition(s) this trial relates to.

lymphoma neoplasm

As listed by the trial registrant

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

Solid tumors or lymphoma

Contacts and locations

Locations

  • First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003, China

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