Can a new injection tame advanced solid tumors?

NCT ID NCT07775703

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This early-stage trial is testing an experimental drug called HS-20117-2 in people with advanced solid tumors. The main goals are to understand how the drug behaves in the body, check its safety, and see how well people tolerate it. Participants receive the drug as a subcutaneous injection, and researchers will monitor side effects and drug levels over time.

What this could mean

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

Active substance
HS-20117-2 injection (an experimental drug given as a subcutaneous injection)
What this could lead to
If successful, this could lead to a new treatment option for advanced solid tumors, potentially slowing disease progression or shrinking tumors.
What could go wrong
This is an early-phase trial with a small number of participants, so the drug may not be effective or may cause unexpected side effects. Success in this trial does not guarantee approval or widespread use.

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 60 people

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

Started

Nov 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 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. Aged 18 to 75 years, male or female. 2. According to RECIST v1.1, the investigator assesses that the participant has at least one target lesion. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 1, with no deterioration within 2 weeks prior to the first dose. 4. Minimum life expectancy greater than 12 weeks. 5. Female patients of childbearing potential, from signing the informed consent until 6 months after the last dose, are willing to adopt appropriate contraceptive measures and should not be breastfeeding; male patients, from signing the informed consent until 6 months after the last dose, are willing to use barrier contraception (i.e., condoms). 6. Female patients must have a negative blood pregnancy test result within 7 days prior to the first dose, or demonstrate no risk of pregnancy. 7. Voluntarily participate in this clinical trial, understand the study procedures, and be capable of providing written informed consent. Exclusion Criteria: 1. Presence of prior anti-tumor therapy-related toxicities with a severity ≥ Grade 2 (according to CTCAE v5.0), excluding alopecia and neurotoxicity. 2. Meeting any of the following cardiac criteria: 1. Mean QT interval corrected by Fridericia's formula (QTcF) \> 470 msec on resting ECG. 2. Resting ECG abnormalities indicating clinically significant rhythm, conduction, or morphological abnormalities as judged by the investigator (e.g., complete left bundle branch block, third-degree atrioventricular block, second-degree atrioventricular block, PR interval \> 250 msec). 3. Presence of any factor that increases the risk of QT prolongation or arrhythmic events judged by the investigator as clinically significant (e.g., heart failure, refractory hypokalemia, congenital long QT syndrome, family history of long QT syndrome, unexplained sudden death in a first-degree relative under 40 years of age, or any concomitant medication known to prolong the QT interval). 4. Left ventricular ejection fraction (LVEF) \< 50%. 3. Presence of severe, uncontrolled, or active cardiovascular or cerebrovascular diseases. 4. Severe or poorly controlled hyperglycemia. 5. Severe or poorly controlled hypertension. 6. Clinically significant bleeding symptoms or obvious bleeding tendency within 1 month prior to the first dose of study treatment. 7. History of severe arterial or venous thrombotic events within 3 months prior to the first dose of study treatment. 8. Ongoing or active infection within 4 weeks prior to the first dose of study treatment. 9. Current or anticipated requirement for long-term (≥ 30 days) systemic corticosteroid therapy (\>10 mg/day prednisone or equivalent) within 30 days prior to enrollment, except for patients requiring chronic inhaled corticosteroids for asthma or topical corticosteroid use. History of immunodeficiency, other acquired or congenital immunodeficiency diseases, or history of organ transplant or allogeneic bone marrow transplantation (excluding corneal transplant). 10. Presence of active infectious diseases. 11. History of hepatic encephalopathy, hepatorenal syndrome, or cirrhosis ≥ Child-Pugh class B. 12. Presence of interstitial lung disease (ILD). Evidence of active pneumonia on chest imaging during screening. Patients requiring long-term continuous oxygen therapy. 13. Severe neurological or psychiatric disorders that may interfere with study evaluation. 14. Female patients who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study or within 6 months after the last dose of the investigational product. 15. History of severe allergies, or known hypersensitivity to any component of HS-20117 or drugs in the same class as HS-20117. 16. Patients judged by the investigator as likely to have poor compliance with the study procedures and requirements. 17. Any condition that, in the investigator's judgment, jeopardizes patient safety or interferes with the study evaluation.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    1 site. 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

  • The First Affiliated Hospital of Guangzhou Medical University

    RECRUITING

    Guangzhou, Guangdong, 510140, China

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