New drug duo aims to shrink hard-to-treat tumors
NCT ID NCT07073534
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a combination of two experimental drugs, SHR-1501 and adbelizumab, in people with advanced or metastatic solid tumors that have not responded to standard treatments. The goal is to find a safe dose and see if the combination can shrink tumors. About 203 adults aged 18 to 75 will take part across multiple centers.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 203 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jul 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 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: 1. Voluntarily participate in this clinical study, understand the research procedures and be able to sign the informed consent form in person. 2. Age: 18 to 75 years old (including both ends), gender not limited. 3. Subjects with locally advanced or metastatic solid tumors that have been histologically or cytologically confirmed to be inoperable for radical surgery or radical chemoradiotherapy, whose disease progresses after standard treatment, or who have no standard treatment plan, or are not suitable for standard treatment. 4. According to the efficacy evaluation criteria for Solid tumors (RECIST 1.1), there is at least one measurable lesion; 5. The ECOG physical condition score is 0 or 1. 6. The expected survival time is more than 3 months; Exclusion Criteria: 1. Symptomatic or active central nervous system (CNS) tumor metastasis; 2. Other malignant tumors within five years before the first use of study drugs; 3. Uncontrolled tumor-related pain judged by the investigator; 4. Severe cardiovascular and cerebrovascular diseases; 5. Significant clinical bleeding symptoms within 3 months before the first study drug, and obvious fresh hemoptysis within 1 month before the first study drug; 6. Uncontrollable pleural effusion and/or ascites judged by the study or pleural effusion and/or ascites requiring intervention within 7 days before the first treatment 7. History of idiopathic pulmonary fibrosis, organizing pneumonia (such as bronchiolitis obliterans), drug-related pneumonia requiring steroid therapy;,or active pneumonia at screening; or other moderate to severe pulmonary diseases that significantly affect pulmonary function; 8. Severe infection within 4 weeks before the start of study treatment 9. History of immunodeficiency 10. Used corticosteroids (\>10 mg/day prednisone or equivalent) or other systemic immunosuppressants within 14 days before the first study drug. 11. Patients with active pulmonary tuberculosis infection within 1 year before enrollment as determined by medical history or imaging examination, or patients with a history of active pulmonary tuberculosis infection more than 1 year ago but without formal treatment 12. Patients whose adverse events caused by previous treatment have not recovered to ≤CTCAE grade 1 13. Patients whose previous treatment washout does not meet the following requirements: Patients who have received chemotherapy, biological therapy, targeted therapy, immunotherapy, or other unlisted clinical research drugs and other anti-tumor treatments within 4 weeks before the first use of the study drug 14. Patients who have experienced CTCAE grade 4 or grade 3 immune-related adverse events lasting for 4 weeks or longer after previous use of immune checkpoint inhibitors, or immune-related adverse events that led to treatment discontinuation, are not eligible for enrollment in this study. 15. Patients who have received \>30 Gy chest radiotherapy within 24 weeks before the first use of the study drug, patients who have received \>30 Gy non-chest radiotherapy within 4 weeks before the first use of the drug (subjects who have completed brain metastasis radiotherapy 14 days before the first use of the drug can be enrolled), and patients who have received ≤30 Gy within 14 days before the first use of the drug Gy of palliative radiation; 16. Subjects who have undergone surgery on important organs (excluding puncture biopsy) within 4 weeks before the first use of the study drug, have had significant trauma, or need to undergo elective surgery during the trial; 17. Active, known or suspected autoimmune diseases and history of autoimmune diseases. 18. Using attenuated live vaccines within 28 days before the first use of the study drug, or anticipating the need to use attenuated live vaccines during the study treatment; 19. Pregnant or lactating women or female subjects who plan to become pregnant during the study and within 6 months after the last use of the study drug; 20. Those who are known to be allergic to any component or excipient of the study drug; or have a history of severe allergic reactions to other monoclonal antibodies/fusion protein drugs; 21. The investigators judge that the subjects have other factors that may affect the study results or force the termination of this study, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring combined treatment, serious abnormal laboratory test values, family or social factors, and other situations that may affect the safety of the subjects or the collection of trial data.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Patients with advanced or metastatic 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
-
Sun Yat-sen University Cancer Center
RECRUITINGGuangzhou, Guangdong, 510000, China