A Phase 1/2 interventional study of SHR-7787 injection in Advanced Solid Tumors, sponsored by Shanghai Hengrui Pharmaceutical Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Shanghai Hengrui Pharmaceutical Co., Ltd. (part of Jiangsu HengRui Medicine Co., Ltd.) · Phase 1/2, Interventional, and Treatment
The study is being conducted to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of SHR-7787 injection monotherapy for patients with advanced solid tumors. To explore the reasonable dosage of SHR-7787 injection monotherapy for patients with advanced solid tumors.
Shanghai Hengrui Pharmaceutical Co., Ltd. is the lead sponsor of 61 studies on the registry; 31 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: SHR-7787 injection
Firstly Dose Escalation and Dose Expansion of SHR-7787 injection monotherapy should be conducted.
Maximum tolerated dose
The Maximum tolerated dose of SHR-7787 injection monotherapy
Time frame: first dose of study medication up to 21 days
Recommended phase II dose
The Recommended phase II dose of SHR-7787 injection monotherapy
Time frame: first dose of study medication up to 21 days
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: from signature completion of ICF to 60 days after the last dose or to the beginning of the new anti-cancer therapy, whichever came first, assessed up to 24 weeks
Incidence of Dose Limited Toxicity (DLT)
Incidence of Dose Limited Toxicity (DLT) described in the protocol
Time frame: from first dose to 4 weeks
Tmax
PK parameters of single dose of SHR-7787 injection monotherapy
Time frame: predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose
Cmax
PK parameters of single dose of SHR-7787 injection monotherapy
Time frame: predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose
AUC0-t
PK parameters of single dose of SHR-7787 injection monotherapy
Time frame: predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose
t1/2
PK parameters of single dose of SHR-7787 injection monotherapy
Time frame: predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose
ADA
Anti-drug antibody, Immunogenicity of SHR-7787 in monotherapy
Time frame: 0.5 hour before first dose through study completion, an average of 1 year
ORR
Objective Response Rate, Efficacy endpoints of SHR-7787 injection monotherapy in treatment of patients with advanced solid tumors
Time frame: from the date of the first dose to the date of disease progression evaluated based on RECIST v1.1 criteria, death, lost to follow-up, voluntary withdrawal, or initiation of other anti-tumor treatment, whichever occurs first, assessed up to 6 months
Plan to share: Undecided
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