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New 'Double Punch' drug takes on advanced tumors

NCT ID NCT07016490

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial is testing a new drug called SSGJ-709 in 15 people with advanced cancers that have spread. The drug is designed to block two immune system brakes (PD-1 and LAG-3) at once, potentially helping the body fight tumors. The main goals are to check safety and how the drug moves through the body, with a preliminary look at whether it shrinks tumors.

What this could mean

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

Active substance
SSGJ-709 (a bispecific antibody that targets two immune checkpoints, PD-1 and LAG-3)
What this could lead to
If this early trial shows safety and hints of tumor shrinkage, it could lead to a new treatment option for advanced cancers that have not responded to other therapies.
What could go wrong
This is a very early (Phase 1) and small (15 participants) study focused on safety, not effectiveness. The drug may cause side effects or fail to shrink tumors. Results may not apply to all cancer types.

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 15 people

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

Started

Jun 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.

Inclusion Criteria: * Minimum life expectancy of 3 months; * Eastern Cooperative Oncology Group (ECOG) Performance status (PS) score of 0-1; * Locally advanced or metastatic malignant tumors confirmed by histopathology or cytology; preferred tumor types for enrollment include head and neck squamous cell carcinoma, non-small cell lung cancer, esophageal squamous cell carcinoma or adenocarcinoma, gastric or gastroesophageal junction adenocarcinoma, colorectal adenocarcinoma, hepatocellular carcinoma, urothelial carcinoma, and clear cell renal cell carcinoma. Subjects with other tumor types may be enrolled after discussion with the sponsor; * Subject who have failed, or has been intolerant to standard therapy, or has been considered lack standard of care for a given tumor type, and who is not able to complete surgical resection and receive curative concurrent/sequential chemoradiotherapy; * Having at least one measurable tumor lesion as the target lesion assessed per RECIST v1.1; * The subject has adequate hematological and organ functions; Exclusion Criteria: * Presence of brainstem, meningeal metastases, spinal cord metastases or compression; * Presence of active central nervous system (CNS) metastases; * Subjects with pleural effusion, pericardial effusion, or ascites that are clinically symptomatic or require repeated drainage; * Subjects with other malignant tumors within 3 years prior to screening; * Subjects with autoimmune diseases that require systemic treatment within 2 years before screening; * Subjects are positive for human immunodeficiency virus (HIV); * Prior or current presence of non-infectious pneumonia/interstitial lung disease requiring systemic therapy with glucocorticoids; * Serious infection within 4 weeks prior to the first dose or the presence of any active infection requiring systemic anti-infective therapy. * Having received the following treatments prior to the first dose of study treatment: 1. Having received anti-tumor therapies such as biological agents, chemotherapy and other investigational drugs not approved for marketing within 3 weeks prior to the first dose of study treatment (Patient may be enrolled if the first dose of study treatment is more than 5 half-lives of the drug from the last anti-tumor therapy); 2. Having received small molecule targeted antineoplastic agents (e.g., tyrosine kinase inhibitor), or palliative local therapy for non-target lesions, or non-specific immunomodulatory therapy (e.g., interleukin, interferon, thymosin, tumor necrosis factor) within 2 weeks prior to the first dose; 3. Having received herbal medicine with an anti-tumor indication within 1 week prior to the first dose; 4. Prior immunotherapy other than anti-PD-(L)1 therapy (Patients with prior immunotherapy against other targets may be enrolled after discussion and agreement with the sponsor).

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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

  • Southern Oncology Clinical Research Unit (SOCRU)

    RECRUITING

    Adelaide, Australia

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