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New drug IBI129 tested in humans for first time against Hard-to-Treat cancers

NCT ID NCT05991349

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested an experimental drug called IBI129 in 36 adults with advanced solid tumors that could not be removed by surgery or had spread. The main goals were to find a safe dose and check for side effects. Researchers also looked for any signs that the drug might control tumor growth. Because this is a first-in-human study, the results are very preliminary and do not yet show whether IBI129 is an effective treatment.

What this could mean

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

Active substance
IBI129 (an experimental drug given by infusion every 3 weeks)
What this could lead to
If it works, this could point toward a new treatment option for people with advanced solid tumors that have not responded to other therapies.
What could go wrong
This is a very early, first-in-human study with only 36 participants. The drug may not shrink tumors or may cause side effects. Success in this small trial does not guarantee it will work for larger groups.

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

36 people

The number who actually took part.

Started

Mar 2024

Finished

May 2025

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. Subjects with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol; 2. At least 1 evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.; 3. Male or female subjects ≥ 18 years old; 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1; 5. Anticipated life expectancy of ≥ 12 weeks; 6. Adequate bone marrow and organ function Exclusion Criteria: 1. Participate in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of the interventional study; 2. Received previous anti-tumor therapy within 4 weeks or 5 half-lives of the anti-tumor regimens before the first administration of study drug, whichever is shorter. 3. Progressed refractory to an antibody drug conjugate that consists of an exatecan derivative that is a topoisomerase I inhibitor. 4. Plan to receive other antitumor therapy during the study excluding palliative radiotherapy for the purpose of symptom (like pain) relief that must also do not have impact on tumor assessment throughout the study; 5. Known symptomatic central nervous system (CNS) metastases.

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

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

Solid tumor

Contacts and locations

Locations

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050, Australia

  • Hubei Cancer Hospital

    Wuhan, Hubei, China

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117, China

  • St George private Hospital

    Kogarah, New South Wales, 2217, Australia

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021, China

  • Tianjin Medical university cancer institute & Hospital

    Tianjin, Tianjin Municipality, 300000, China

  • Wollongong Hospital

    Wollongong, New South Wales, 2500, Australia

More trials for these conditions

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