Can a new injection shrink advanced solid tumors?
NCT ID NCT07789327
First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time
Summary
This phase 1/2 trial tests an investigational drug called HY07121, given as a subcutaneous injection, in adults with advanced solid tumors that have not responded to standard treatments or for which no standard treatment exists. The study has two parts: the first finds a safe dose, and the second checks whether the drug can shrink tumors. Researchers will monitor side effects and measure how the drug moves through the body.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HY07121 for injection (subcutaneous)
- What this could lead to
- If it works, this could offer a new treatment option for people with advanced solid tumors who have run out of standard therapies.
- What could go wrong
- This is an early-phase trial, so the drug may not be safe or effective in a larger group. Side effects are possible, and the results are not yet known.
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 254 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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: * Written informed consent; * ≥18 years old and ≤80 years old, gender: male or female; * Dose escalation part: cytologically or histopathologically confirmed locally advanced or advanced solid tumor that has failed standard therapy, or for which no standard therapy exists, or for which standard therapy is not tolerated or has been refused (for tumor types for which PD-1/PD-L1-related inhibitors are approved in China, failure of prior PD-1/PD-L1-related inhibitor therapy is required). Solid tumors in the dose expansion part include non-small cell lung cancer (driver gene-negative), gastric cancer, esophageal cancer, Microsatellite Instability-High / Mismatch Repair-Deficient Solid Tumors (MSI-H/dMMR) solid tumors, cervical cancer, non-muscle-invasive bladder cancer, head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma), renal cell carcinoma, and other tumor types; * Dose escalation part: at least one evaluable tumor lesion is required. Dose expansion part: at least one measurable tumor lesion is required (per RECIST v1.1); * Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1; * Life expectancy ≥3 months; * Participant must have adequate main organ function; * Fertile female patients must have a negative serological pregnancy test within 7 days before the first dosing and be willing to use effective birth control/contraception to prevent pregnancy during the study period up to 6 months after the last dosing of the study. Male patients must agree to have no sperm donation plans and to use effective contraceptive methods during the study period until 6 months after the last dose of the study. * Postmenopausal women must have amenorrhea for at least 12 months before they are considered infertile. Exclusion Criteria: * Within the defined washout periods for prior anti-cancer treatments; * Participant is currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of first dose of HY07121. * Any other malignancy within 2 years prior to the first dose of the study treatment except for localized cancers that are considered to have been cured and in the opinion of the Investigator present a low risk for recurrence. * Participant has not recovered (i.e., to Grade 1 or to baseline) from previous anticancer therapy-induced Adverse Events (AEs). * Participants with a history of recently (within previous 2 years of the first dose of the study treatment) active diverticulitis or symptomatic peptic ulcer disease; * Major surgery within 4 weeks of receiving the first dose of study treatment; * Participant has Symptomatic Central Nervous System (CNS) metastases, or CNS metastases requiring CNS-directed local therapy (such as radiotherapy or surgery) or corticosteroids therapy within 4 weeks of first dose of study treatment; * Participants with untreated or under treatment for tuberculosis, including but not limited to tuberculosis; Patients who have received standardized anti-tuberculosis treatment and have been confirmed cured by the researchers can be included; * Participants with clinically significant cardiovascular diseases, in the past 6 months prior to the first dose of the study treatment; symptomatic coronary heart disease requiring drug treatment; arrhythmia requiring drug treatment; or uncontrolled hypertension; * Known Human Immunodeficiency Virus (HIV) infection or known Acquired Immunodeficiency Syndrome (AIDS); * Active or chronic hepatitis B or hepatitis C infection; treponema pallidum antibody positive, and confirmed positive test; * Active known or suspected autoimmune disease. * History of non-infectious pneumonitis that has required a course of oral or intravenous steroids to assist with recovery, or interstitial lung disease or severe obstructive pulmonary disease; * History of severe allergy; * History of allogeneic organ transplantation or graft-versus-host disease; * Have received live/attenuated vaccines and messenger ribonucleic acid(mRNA) vaccines within 4 weeks prior to screening or plan to receive live/attenuated vaccines and mRNA vaccines during the study period; * Any active infection requires systemic treatment via intravenous infusion within 4 weeks prior to the first dose of study treatment; * Known psychiatric disorder or drug abuse that would interfere the trial requirements; * Participant with uncontrolled pleural effusion, pericardial effusion or peritoneal effusion or need drainage; * In addition to the tumors present at the time of entry into the study, other active malignancies were present within 3 years prior to the first dose (not excluding locally cured tumors, such as skin basal cell carcinoma, superficial bladder cancer or carcinoma in situ of the breast, etc.); * Participants considered unsuitable for participation in this study by the investigators.
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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.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
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Other studies related to the condition(s) this trial covers.
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