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New hope for Hard-to-Treat cancers: experimental drug enters human trials

NCT ID NCT04900818

Disease control Sponsor: I-Mab Biopharma US Limited 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tests an experimental drug called TJ033721 (givastomig) in people with advanced or metastatic solid tumors that have stopped responding to standard treatments. The main goals are to check the drug's safety, find the right dose, and see how the body processes it. About 330 participants will receive the drug alone or in combination with other therapies.

Why investors are watching

I-Mab Biopharma is running a phase 1 trial of TJ033721, a drug called givastomig, in 330 people with advanced or metastatic solid tumors. The trial tests the drug's safety, how well the body tolerates it, and whether it controls the disease. For a very small company, this early readout matters because it is the first test of whether the drug works in people, and the result will shape the company's future value.

If it works: If the trial shows the drug is safe and controls tumors, I-Mab could move the drug into later-stage testing. That progress could attract partners or funding to keep the drug development going.

If it fails: Phase 1 trials often fail because the drug proves unsafe or does not work. A failure or delay would leave I-Mab without a clear path for this drug, which could hurt the company's prospects.

AI-written from the trial record. Speculative, and not investment advice.

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 330 people

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

Started

Jun 2021

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.

Inclusion Criteria: Part 1 - Monotherapy Subjects with advanced or metastatic solid tumor in subjects whose disease has progressed despite standard therapy, or who has no further standard therapy, or who is unsuitable for available standard treatment options. Part 2 - Combination Therapy Subjects with treatment naïve locally advanced, unresectable or metastatic gastric, GEJ, esophageal adenocarcinoma; Part 3: Combination Therapy Subjects with unresectable, locally advanced or metastatic histologically confirmed pancreatic adenocarcinoma; Part 4: Combination Therapy Subjects with unresectable, locally advanced or metastatic histologically confirmed biliary tract cancer. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 with adequate organ function * Have known PD-L1 status with prior testing by immunohistochemistry and a corresponding combined positive score (CPS) For dose expansion and Part 2, Part 3, Part 4 Combination subjects: • Must have CLDN18.2-positive tumor expression Exclusion Criteria * Prior exposure to CLDN18.2 -targeted therapy * Prior exposure to 4-1BB agonists * Second malignancy within the last 3 years with the exception of cutaneous squamous cell carcinoma or cutaneous basal cell carcinoma or cervical carcinoma in situ * Known active or chronic Hepatitis B or Hepatitis C, other hepatitides * Unstable/active ulcer or digestive tract bleeding within 6 weeks * Active autoimmune disease requiring systemic treatment within the past 2 years * Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or pneumonitis requiring treatment * Known active CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment; * New York Heart Association (NYHA) Class 3 or 4 congestive heart failure, severe/unstable angina, myocardial infarction (MI), symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack (TIA), arterial embolism, percutaneous transluminal coronary angioplasty (PTCA), or coronary artery bypass grafting (CABG) in the previous 6 months * Diagnosis of immunodeficiency such as known active HIV * Any active infection requiring parenteral treatment For Part 2, 3, 4 Combination subjects: • Prior treatment with anti-PD-1 or PD-L1 agent

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Conditions

The condition(s) this trial relates to.

Adenocarcinoma Of Esophagus biliary tract cancer Biliary Tract Neoplasms cancer esophageal adenocarcinoma gastric cancer gastric neoplasm gastroesophageal junction adenocarcinoma metastatic malignant neoplasm Neoplasm Metastasis pancreatic ductal adenocarcinoma

As listed by the trial registrant

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

Advanced cancer Biliary tract cancer (BTC) Esophageal adenocarcinoma Gastric cancer Gastroesophageal junction carcinoma Metastatic cancer Pdac - pancreatic ductal adenocarcinoma Solid tumor

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    7 sites in 2 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

  • Carolina BioOncology Institute

    COMPLETED

    Huntersville, North Carolina, 28078, United States

  • HARBIN Medical University Cancer Hospital

    COMPLETED

    Harbin, Heilongjiang, 150086, China

  • Henan Cancer Hospital

    COMPLETED

    Zhengzhou, Henan, 45003, China

  • Horizon Oncology Research, LLC.

    COMPLETED

    Layfayette, Indiana, 47905, United States

  • Hubei Cancer Hospital

    COMPLETED

    Wuhan, Hubei, 430079, China

  • Mary Crowley Cancer Research

    COMPLETED

    Dallas, Texas, 75230, United States

  • Mass General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • NYU Langone

    RECRUITING

    New York, New York, 10016, United States

  • Rutgers Cancer Institute of New Jersey

    COMPLETED

    New Brunswick, New Jersey, 08901, United States

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    COMPLETED

    Hangzhou, Zhejiang, 3110020, China

  • Sixth Affiliated Hospital, Sun Yat-sen University

    ACTIVE_NOT_RECRUITING

    Guangzhou, Guangdong, 510655, China

  • Stern Center for Cancer Clinical Trials and Research

    RECRUITING

    Orange, California, 92868, United States

  • The First Hospital of China Medical University

    COMPLETED

    Shenyang, Liaoning, 110499, China

  • The Second Hospital of Anhui Medical University

    WITHDRAWN

    Hefei, Anhui, 230601, China

  • Tianjin Medical University Cancer Institute and Hospital

    COMPLETED

    Tianjin, Tianjin Municipality, 300060, China

  • UCHealth Cancer Care - Anschutz Medical Campus

    RECRUITING

    Aurora, Colorado, 80045, United States

  • UW Carbone Cancer Center

    RECRUITING

    Madison, Wisconsin, 53705, United States

  • Vanderbilt-Ingram Cancer Center

    COMPLETED

    Nashville, Tennessee, 37232, United States

  • Zhongshan Hospital, Fudan University

    COMPLETED

    Shanghai, Shanghai Municipality, 200032, China

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