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Can a new drug shrink Hard-to-Treat tumors?

NCT ID NCT05718219

Disease control Sponsor: Jiangsu Simcere Pharmaceutical 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 SIM0348, given alone or with another drug (sintilimab), in adults with advanced solid tumors that have not responded to standard treatments. The main goals are to check the safety and tolerability of the drug, how it moves through the body, and whether it shows any signs of shrinking tumors. Participants receive the drug through an IV infusion in repeated cycles until the disease progresses or they no longer benefit.

What this could mean

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

Active substance
SIM0348, an experimental drug given by IV infusion, tested alone and in combination with sintilimab
What this could lead to
If successful, this could lead to a new treatment option for people with advanced solid tumors who have exhausted standard therapies.
What could go wrong
This is an early-phase trial with a small number of participants, so safety and effectiveness are not yet established. The drug may not work or may cause significant side effects.

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

49 people

The number who actually took part.

Started

Mar 2023

Finished

Apr 2026

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: * Adults 18 years of age or older * Must have failed at least one established standard anti-cancer therapies * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Life expectancy at least 12 weeks * Adequate hematologic and end organ function * Histologic documentation of locally advanced, recurrent, or metastatic incurable malignancy that has progressed after at least one available standard therapy; or for which standard therapy has proven ineffective, intolerable, or considered inappropriate; or for which a clinical trial of an investigational agent is a recognized standard of care * Confirmed availability of representative tumor specimens * Measurable disease according to RECIST Version 1.1 Exclusion Criteria: * Malignancies other than disease under study within 2 years prior to Day 1 of Cycle 1 * Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases * History of interstitial lung disease, evidence of active pneumonitis (history of radiation pneumonitis in the radiation field \[fibrosis\] is permitted), and active pneumonia that are considered inappropriate by the investigator * History of severe hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins * History of autoimmune disease * Positive human immunodeficiency virus (HIV) test * Severe infection within 2 weeks prior to the first dose of study treatment * Significant cardiovascular disease * History of allogeneic tissue/solid organ transplant or graft-versus-host disease * Known clinically significant liver disease

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As listed by the trial registrant

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

Advanced solid tumors

Contacts and locations

Locations

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, China

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