New 'Double Punch' drug takes on advanced tumors
NCT ID NCT07016490
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 Hide 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).
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Advanced malignant tumors are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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)
RECRUITINGAdelaide, Australia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New pill targets cancer growth at the genetic level
- New drug duo shows promise for tough cancers
- New cancer drug LBL-033 tested in 26 patients – safety first
- New cancer drug SG2918 enters first human tests
- Two-Antibody combo takes on advanced cancers
- New drug cocktail shows promise against tough cancers