Advanced Solid TumorsPhase 1/2NCT06643754
A Clinical Study of SHR-3276 for Injection in Patients With Advanced Malignant Tumors
A Phase 1/2 study testing SHR-3276 in people with Advanced Solid Tumors, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
This study is an open-label, multicenter Phase I/II clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-3276 for injection in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- SHR-3276
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2024to 30 Dec 2028
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to sign a written informed consent；
- Age 18-70 years old (including both ends), both male and female；
- Pathologically confirmed advanced malignant tumors that have failed sufficient standard treatment or have no effective standard treatment plan；
- Existence of measurable lesions；
- ECOG score: 0-1；
- Expected survival time ≥ 12 weeks；
- The functional level of the major organs must meet the requirements；
- Fertile female patients must have a serum pregnancy test within 7 days before the first medication and the result is negative; And must be non-lactating.
Who cannot join
- Central nervous system metastasis or meningeal metastasis with clinical symptoms;
- Spinal cord compression that has not been treated radically by surgery and/or radiotherapy；
- Patients with uncontrolled tumor-related pain as judged by the investigator
- A third space effusion with uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion, as determined by the investigator；
- Systemic antitumor therapy was administered within 28 days prior to treatment in the first study；
- Surgical procedures requiring tracheal intubation and general anesthesia were performed within 28 days prior to the initial study, or elective surgery was expected during the trial period；
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- Serious drug-related adverse reactions during previous immune checkpoint inhibitor therapy；
- Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤ 1；
- Live attenuated vaccines were used within 28 days prior to administration in the first study or were expected to be required during the study treatment；
- Systemic immunosuppressive therapy was administered within 14 days prior to the first study
- Arterial/venous thrombosis events occurred within 3 months prior to initial administration
- Patients with clinical significant lung disease;
- Patients with history of autoimmune diseases;
- The first study studied any other malignancy within 5 years prior to medication
- A known history of severe allergic reactions to the investigational drug and its principal formulation ingredients；
- Have a history of immune deficiency or organ transplantation；
- Other serious accompanying illnesses, which, in the investigator's assessment, could seriously adversely affect the safety of the treatment.
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
The Second Affiliated Hospital of PLA Army Medical University
Chongqing, Chongqing Municipality, 400037
Bo Zhu
About this study
Official title: A Phase I/II Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-3276 Injection in Patients With Advanced Malignant Tumors
This study is an open-label, multicenter Phase I/II clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-3276 for injection in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- SHR-3276
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-3276Drug
Dose Escalation: SHR-3276 will be administered intravenously. 4 dose levels are preset.
Dose Expansion: 2 to 3 dose cohorts will be selected for dose expansion stage.
Indication Expansion: Indications will be selected to evaluate preliminary efficacy.
| Study group | Role | What they receive |
|---|---|---|
| SHR-3276 for Injection will be administrated per dose level in which the patients are assigned. | Experimental | Not described Receives: Drug: SHR-3276 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events
Measured: up to 3 years
MTD
Measured: up to 6 months
RP2D
Measured: up to 1 year
Secondary outcomes (9)
Time to maximum concentration (Tmax)
Measured: up to 3 years
Maximum concentration (Cmax)
Measured: up to 3 years
Receptor Occupancy（OR） of SHR-3276
Measured: up to 3 years
Anti-drug antibody (ADA) of SHR-3276
Measured: up to 3 years
Objective response rate (ORR)
Measured: From date of administration until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years
Duration of response (DoR)
Measured: From date of administration until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years
Disease control rate (DCR)
Measured: From date of administration until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years
Progression free survival（PFS）
Measured: From date of administration until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years
Overall survival (OS)
Measured: From date of administration until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start10 Dec 2024
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2028 (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 Suzhou Suncadia Biopharmaceuticals 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
- Single arm study of SHR-3276
- Masking
- None (open label)
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06643754
- Sponsor's protocol ID
- SHR-3276-101
- Status last verified
- Oct 2024
- First submitted
- 14 Oct 2024
- Last updated
- 8 Jan 2025
- 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 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-3276 Injection in Patients With Advanced Malignant Tumors
- ClinicalTrials.gov ID
- NCT06643754
- Acronym / sponsor ID
- SHR-3276-101
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 16 Oct 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.
This study is an open-label, multicenter Phase I/II clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-3276 for injection in 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
- Single arm study of SHR-3276
| Arm | Type | Receives |
|---|---|---|
| SHR-3276 for Injection will be administrated per dose level in which the patients are assigned. | Experimental | Drug: SHR-3276 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Able and willing to sign a written informed consent；
- Age 18-70 years old (including both ends), both male and female；
- Pathologically confirmed advanced malignant tumors that have failed sufficient standard treatment or have no effective standard treatment plan；
- Existence of measurable lesions；
- ECOG score: 0-1；
Key exclusion criteria (17 listed)
- Central nervous system metastasis or meningeal metastasis with clinical symptoms;
- Spinal cord compression that has not been treated radically by surgery and/or radiotherapy；
- Patients with uncontrolled tumor-related pain as judged by the investigator
- A third space effusion with uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion, as determined by the investigator；
- Systemic antitumor therapy was administered within 28 days prior to treatment in the first study；
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-3276Dose Escalation: SHR-3276 will be administered intravenously. 4 dose levels are preset. Dose Expansion: 2 to 3 dose cohorts will be selected for dose expansion stage. Indication Expansion: Indications will be selected to evaluate preliminary efficacy. | Drug | SHR-3276 for Injection will be administrated per dose level in which the patients are assigned. |
Primary outcome
Incidence and severity of adverse events
Time frame: up to 3 years
MTD
Time frame: up to 6 months
RP2D
Time frame: up to 1 year
9 secondary outcomes
Time to maximum concentration (Tmax)
Time frame: up to 3 years
Maximum concentration (Cmax)
Time frame: up to 3 years
Receptor Occupancy（OR） of SHR-3276
Time frame: up to 3 years
Anti-drug antibody (ADA) of SHR-3276
Time frame: up to 3 years
Objective response rate (ORR)
Time frame: From date of administration until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years
Duration of response (DoR)
Time frame: From date of administration until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years
Disease control rate (DCR)
Time frame: From date of administration until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years
Progression free survival（PFS）
Time frame: From date of administration until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years
Overall survival (OS)
Time frame: From date of administration until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years
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 8 Jan 2025.
- 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-3276 in people with Advanced Solid Tumors, run by Suzhou Suncadia Biopharmaceuticals 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 8 inclusion and 17 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 8 Jan 2025. 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 Zhenqun Lu (+0518-81220121, zhenqun.lu@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (time frame: up to 3 years). The study lists 3 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 8 Jan 2025.