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First-in-Human trial tests IBI3001 against advanced solid tumors

NCT ID NCT06349408

Disease control Sponsor: Fortvita Biologics (USA)Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 25, 2026 · Last updated Sep 25, 2026

Summary

Researchers are running a Phase 1 trial of IBI3001, an intravenous drug, in adults with unresectable, locally advanced or metastatic solid tumors. The study aims to find the highest dose people can tolerate and the dose to use in later trials. Participants receive IBI3001 by infusion, and doctors track side effects, vital signs, and blood levels of the drug. The trial also looks for early signs that the drug affects tumors.

What this could mean

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

Active substance
IBI3001, an experimental intravenous drug
What this could lead to
If IBI3001 proves safe and shows early signs of activity, it could become a new option for people with advanced solid tumors that have not responded to other treatments.
What could go wrong
This is a first-in-human Phase 1 trial, so the main goal is safety, not cure. The drug may cause serious side effects, and it may not shrink tumors at all. Results from a small early study often do not hold up in larger trials.

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

About 250 people

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

Started

Jan 2025

Expected to finish

Dec 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.

Key Inclusion Criteria: 1. Male or female participants ≥ 18 years old; 2. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1; 3. Has an anticipated life expectancy of ≥ 12 weeks; 4. Adequate bone marrow and organ function: 5. At least 1 evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. for dose escalation , and 1 measurable lesion for dose expansion. 6. Has a documented (histologically- or cytologically-proven), unresectable, locally advanced or metastatic solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available; participants who refuse standard therapy, or are able to suspend standard therapy without major risks. Key Exclusion Criteria: 1. Progressed or refractory to an ADC that consists of an Exatecan derivative that is a topoisomerase I inhibitor or intolerable with an ADC that consists of Exatecan; 2. Plan to receive other antitumor therapy during the study excluding palliative radiotherapy for the purpose of symptom (like pain) relief that must also not have an impact on tumor assessment throughout the study; 3. Pyloric obstruction and/or persistent recurrent vomiting (≥ 3 times in 24 hours); 4. Gastrointestinal perforation and/or fistula within 6 months prior to first administration of the study drug, and not recovered after surgical treatment; 5. Known symptomatic central nervous system (CNS) metastases. 6. History of pneumonia requiring corticosteroids therapy, or history of clinically significant lung diseases; Uncontrolled diseases; 7. History of endotracheal or gastrointestinal stent implantation; 8. Ascites, pleural effusion, or pericardial effusion with symptoms and requiring intervention; 9. Esophageal or gastric varices requiring immediate intervention; 10. Not eligible to participate in this study at the discretion of the investigator; 11. Do not have adequate treatment washout period before study drug administration. -

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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.

Locally advanced solid tumor

How to take part

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

  1. The places running it

    26 sites in 3 countries. 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

  • Anyang Cancer Hospital

    RECRUITING

    Anyang, Henan, 455100, China

  • Cancer Hospital, Chinese Academy of Medical Sciences

    RECRUITING

    Beijing, Beijing Municipality, 100021, China

  • Cancer Research SA

    RECRUITING

    Adelaide, South Australia, 5000, Australia

  • Chinese People's Liberation Army General Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100853, China

  • First Affiliated Hospital, Fujian Medical University

    RECRUITING

    Fuzhou, Fujian, 350005, China

  • Fujian Cancer Hospital

    RECRUITING

    Fuzhou, Fujian, 350014, China

  • Harbin Medical University Cancer Hospital

    RECRUITING

    Harbin, Heilongjiang, 150081, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, 450008, China

  • Jiangsu Province Hospital (The First Affiliated Hospital of Nanjing Medical University)

    RECRUITING

    Nanjing, Jiangsu, 210029, China

  • Jiangxi Cancer Hospital

    RECRUITING

    Nanchang, Jiangxi, 330029, China

  • NEXT Oncology

    RECRUITING

    Dallas, Texas, 75039, United States

  • Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University

    RECRUITING

    Nanjing, Jiangsu, 210008, China

  • START Center for Cancer Research

    RECRUITING

    Los Angeles, California, 90025, United States

  • START Center for Cancer Research

    RECRUITING

    East Brunswick, New Jersey, 08816, United States

  • Shanghai East Hospital, Tongji University School of Medicine

    RECRUITING

    Shanghai, Shanghai Municipality, 200120, China

  • Sichuan Cancer Hospital & Institute

    RECRUITING

    Chengdu, Sichuan, 610041, China

  • The Affiliated Tumor Hospital of Guangxi Medical University

    RECRUITING

    Nanning, Guangxi, 530021, China

  • The First Affiliated Hospital of Anhui Medical University

    RECRUITING

    Hefei, Anhui, 230022, China

  • The First Affiliated Hospital of Henan University of Science and Technology

    RECRUITING

    Luoyang, Henan, 471003, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, Henan, 450052, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310003, China

  • Virginia Cancer Specialists

    ACTIVE_NOT_RECRUITING

    Fairfax, Virginia, 22031, United States

  • West China Hospital, Sichuan University

    RECRUITING

    Chengdu, Sichuan, 610041, China

  • Wollongong Hospital

    RECRUITING

    Wollongong, New South Wales, 2500, Australia

  • Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, 430022, China

  • Xiangya Hospital, Central South University

    RECRUITING

    Changsha, Hunan, 410008, China

  • Zhejiang Cancer Hospital

    RECRUITING

    Hangzhou, Zhejiang, 310022, China

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