Advanced Solid TumorsPhase 1/2NCT06605222
A Trial of SHR-7787 Injection in Patients With Advanced Solid Tumors
A Phase 1/2 study testing SHR-7787 injection in people with Advanced Solid Tumors, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- SHR-7787 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteChina
- Study dates
- 4 Oct 2024to Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;
- Patients with unresectable recurrent or metastatic solid tumors;
- There is at least one lesion could be measured;
- An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
- Adequate organ functions as defined;
- Life expectancy ≥3 months.
Who cannot join
- Patients with known active central nervous system (CNS) metastases;
- Subjects who had other malignancy in five years before the first dose;
- Patients with tumor-related pain that cannot be controlled as determined;
- Patients with serious cardiovascular and cerebrovascular diseases;
- Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion;
- Patients with Severe infections;
Show all 12Show fewer
- History of immunodeficiency;
- History of autoimmune diseases;
- Unresolved CTCAE Grade >1 toxicity attributed to any prior anti-tumor therapy
- Active infection;
- Pregnant or nursing women;
- Known history of serious allergic reactions to the investigational product or its main ingredients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Shengxiang Ren
About this study
Official title: A Phase I/II, Open Label, Multicenter Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-7787 in Patients With Advanced Solid Tumors
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.
- Conditions
- Advanced Solid Tumors
- Being tested
- SHR-7787 injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-7787 injectionDrug
Firstly Dose Escalation and Dose Expansion of SHR-7787 injection monotherapy should be conducted.
| Study group | Role | What they receive |
|---|---|---|
| Single Group: SHR-7787 injection | Experimental | Not described Receives: Drug: SHR-7787 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
The Maximum tolerated dose of SHR-7787 injection monotherapy
Measured: first dose of study medication up to 21 days
Recommended phase II dose
The Recommended phase II dose of SHR-7787 injection monotherapy
Measured: 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
Measured: 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
Measured: from first dose to 4 weeks
Secondary outcomes (6)
Tmax
PK parameters of single dose of SHR-7787 injection monotherapy
Measured: predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose
Cmax
PK parameters of single dose of SHR-7787 injection monotherapy
Measured: predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose
AUC0-t
PK parameters of single dose of SHR-7787 injection monotherapy
Measured: predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose
t1/2
PK parameters of single dose of SHR-7787 injection monotherapy
Measured: predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose
ADA
Anti-drug antibody, Immunogenicity of SHR-7787 in monotherapy
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start4 Oct 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Shanghai Hengrui Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- SHR-7787 injection monotherapy
- Masking
- None (open label)
- Enrolment
- 201 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06605222
- Sponsor's protocol ID
- SHR-7787-101
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Open Label, Multicenter Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-7787 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06605222
- Acronym / sponsor ID
- SHR-7787-101
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 201 participants (estimated)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Oct 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- SHR-7787 injection monotherapy
| Arm | Type | Receives |
|---|---|---|
| Single Group: SHR-7787 injection | Experimental | Drug: SHR-7787 injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;
- Patients with unresectable recurrent or metastatic solid tumors;
- There is at least one lesion could be measured;
- An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
- Adequate organ functions as defined;
Key exclusion criteria (12 listed)
- Patients with known active central nervous system (CNS) metastases;
- Subjects who had other malignancy in five years before the first dose;
- Patients with tumor-related pain that cannot be controlled as determined;
- Patients with serious cardiovascular and cerebrovascular diseases;
- Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-7787 injectionFirstly Dose Escalation and Dose Expansion of SHR-7787 injection monotherapy should be conducted. | Drug | Single Group: SHR-7787 injection |
Primary outcome
Maximum tolerated dose
Time frame: first dose of study medication up to 21 days
The Maximum tolerated dose of SHR-7787 injection monotherapy
Recommended phase II dose
Time frame: first dose of study medication up to 21 days
The Recommended phase II dose of SHR-7787 injection monotherapy
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)
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 and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Incidence of Dose Limited Toxicity (DLT)
Time frame: from first dose to 4 weeks
Incidence of Dose Limited Toxicity (DLT) described in the protocol
6 secondary outcomes
Tmax
Time frame: predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose
Cmax
Time frame: predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose
AUC0-t
Time frame: predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose
t1/2
Time frame: predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose
ADA
Time frame: 0.5 hour before first dose through study completion, an average of 1 year
ORR
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SHR-7787 injection in people with Advanced Solid Tumors, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ke Ma (+0518-81220121, ke.ma@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (time frame: first dose of study medication up to 21 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.