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New drug duo aims to halt advanced cancers

NCT ID NCT05944224

Disease control Sponsor: Shanghai Pharmaceuticals Holding 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 2 times

Summary

This study tests an experimental drug called SPH4336, given alone or with another drug (cadonilimab), in people with advanced solid tumors that cannot be removed by surgery. The goal is to see if the treatment can slow or stop cancer growth. About 63 participants will take part in this early-phase trial.

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

About 63 people

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

Started

Oct 2023

Expected to finish

Dec 2026

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 to 75 years

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 voluntarily participate in this study and sign informed consent. 2. Expected survival ≥3 months. 3. Patients with advanced solid tumors (including advanced Well differentiated/dedifferentiated liposarcoma) who cannot be treated by radical surgery/other local treatment. 4. According to RECIST v1.1, participants in the dose expansion phase must have at least one measurable lesion. 5. The laboratory test results meet the organ function requirements before starting the study treatment. 6. Prior to the start of the study treatment, the peripheral nerve toxicity of previous anti-tumor drug treatment had returned to ≤ grade 2, and other reversible toxic reactions had returned to ≤ grade 1, but hair loss/pigmentation and other effects were assessed by the investigator as beneficial to the subjects receiving the study treatment. The toxicity of the risk is not subject to this limitation. 7. Subjects agree to use effective contraception from the time they sign the informed consent to the last time they use the study drug. Exclusion Criteria: 1. Taking anti-tumor traditional Chinese medicines at the time of signing the ICF. 2. Had undergone surgery prior to treatment and hasn't yet recovered from adverse effects of surgery. 3. Had a history of other malignancies before starting the study. 4. History of myocardial infarction, unstable angina pectoris, severe arrhythmia, and symptomatic congestive heart failure before the start of study treatment; NYHA Class ≥II; QTcF≥ 470 ms; LVEF≤ 50%. 5. Diseases affecting drug administration or gastrointestinal absorption before the start of the study and assessed by the investigators could not be included in the study. 6. Previous history of organ transplantation. 7. Before starting the study, HBsAg positive patients with HBV DNA \> 500IU/ mL or 2500 copies /mL or the lower limit of the study center detection, or HCV antibody positive patients with HCV RNA positive, or known HIV-infected patients, or known active tuberculosis. 8. Accompanied by any other serious, progressive, or uncontrolled disease. 9. Subjects with a known history of immune-related adverse events that the investigator determined could not be included. 10. History of severe allergic disease, history of severe drug allergy, or known allergy to any component of the investigational product. 11. Women who are pregnant or breastfeeding. 12. Any other reason for which patients are ineligible for the study as assessed by the investigator.

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Conditions

The condition(s) this trial relates to.

dedifferentiated liposarcoma neoplasm well-differentiated liposarcoma

As listed by the trial registrant

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

Advanced solid tumors

How to take part

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

  1. The places running it

    16 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

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, China

  • Fujian Cancer Hospital

    RECRUITING

    Fuzhou, Fujian, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, He'nan, China

  • Liaoning Cancer Hospital & Institute

    RECRUITING

    Shenzhen, Liaoning, China

  • Peking Union Medical College Hospital

    RECRUITING

    Beijing, China

  • Peking University People's Hospital

    RECRUITING

    Beijing, China

  • Shanghai Sixth People's Hospital

    RECRUITING

    Shanghai, China

  • The Central Hospital of Yongzhou

    RECRUITING

    Yongzhou, Hunan, China

  • The First Affiliated Hospital，Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, China

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, China

  • Tianjin Medical University Cancer Institute & Hospital

    RECRUITING

    Tianjin, China

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

    RECRUITING

    Wuhan, Hubei, China

  • West China Hospital，Sichuan University

    RECRUITING

    Chengdu, Sichuan, China

  • Xiangya Hospital Central South University

    RECRUITING

    Changsha, Hunan, China

  • Xijing Hospital

    RECRUITING

    Xi’an, Shanxi, China

  • Zhejiang cancer Hospital

    RECRUITING

    Hangzhou, Zhejiang, China

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