New drug ZGGS15 tested in patients with advanced cancers
NCT ID NCT05864573
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tested a new biologic drug called ZGGS15 in 22 adults with advanced solid tumors who had no standard treatment options left. The main goals were to check safety, find the right dose, and look for early signs that the drug might control tumor growth. Participants received the drug by IV infusion once every three weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ZGGS15 (a biologic drug given by IV infusion)
- What this could lead to
- If successful, this could lead to a new treatment option for people with advanced solid tumors who have run out of standard therapies.
- What could go wrong
- This is a very early Phase 1 trial with only 22 participants, so it is primarily testing safety and dosing. The drug may not shrink tumors or may cause 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
-
22 people
The number who actually took part.
- Started
-
Jul 2023
- Finished
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Jun 2025
- 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 70 years
- Sex
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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: * Fully understand the study and voluntarily sign the informed consent form; * Male or female, 18-70 years of age; * Histologically or cytologically confirmed diagnosis of advanced solid tumors, in whom the available standard treatments failed; * Must have at least 1 measurable lesion per RECIST v1.1; * Eastern Cooperative Oncology Group performance status of 0 or 1; * Life expectancy ≥ 3 months; * All adverse events from prior treatment have either returned to baseline or CTCAE v5.0≤Grade 1; * Both male and female participants (unless postmenopausal, surgical sterilization) and partners must agree to use a reliable form of contraception during the study treatment period and for at least 6 months after the last dose of the study drug. Exclusion Criteria: * Medical history, computed tomography (CT) or magnetic resonance imaging (MRI) results indicate the existence of the central nervous system (CNS) metastases; * Uncontrollable third cavity effusion requiring repeated drainage, which was judged by the investigator to be unsuitable for study; * The main organ function meets any of the following criteria within 7 days prior to treatment: * Hematological function: absolute neutrophil count (ANC) \< 1.5 × 10\^9/L, platelet (PLT) \< 75 × 10\^9/L, or hemoglobin (Hb) \< 100 g/L; * Hepatic function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 3 × upper limit of normal (ULN), ALT and AST ≥ 5×ULN for patients with liver metastases; total bilirubin (TBIL) ≥ 1.5×ULN; albumin \< 30 g/L; * Blood cholesterol \> 300 mg/dL or \> 7.75 mmol/L; * Creatinine clearance (Cockcroft-Gault formula) \< 50 mL/min; * International normalized ratio (INR) \> 1.5 or activated partial thromboplastin time (APTT) \> 1.5×ULN; * Any other malignancy within 5 years; * Abnormal thyroid function with clinical symptoms or diabetes, which cannot be controlled by available treatments; * History of autoimmune disease, including but not limited to systemic lupus erythematosus, nephritis, psoriasis, rheumatoid arthritis, inflammatory bowel disease, autoimmune hepatitis; * Previous immune checkpoint inhibitors induced ≥ Grade 2 immune-related adverse reactions in vital organs, including but not limited to myocarditis and central nervous system toxicity; rapidly tumor progressed after previous PD-1 inhibitor treatment; * Interstitial lung disease, non-infectious pneumonitis, and radiation-induced pneumonia with symptoms and/or requiring steroids for treatment; * Received prior allogeneic stem cell transplantation or solid organ transplantation; * Active infection within 1 week before the first administration currently requires systemic anti-infective therapy; * Known allergy to other mAbs or any antibody excipient, severe allergic reaction to humanized antibodies or fusion proteins, and history of anaphylactoid reaction or other hypersensitivity reactions; * Known history of diagnosed neurological or mental disorders, for example, epilepsy, dementia, etc.; * Patients were deemed unsuitable for participating in the study by the investigator for any reason.
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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.
Contacts and locations
Locations
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Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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