Malignant Solid TumorsPhase 1/2NCT06737731
A Phase I/II Clinical Study of SHR-1681 for Injection in Patients With Advanced Solid Tumors
A Phase 1/2 study testing SHR-1681 in people with Malignant 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-1681 for injection in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Malignant Solid Tumors
- What is being tested?
- SHR-1681
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 21 Jan 2025to Jul 2027
- 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
- Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;
- Subjects with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment, or standard treatment is not applicable currently;
- Have at least one measurable tumor lesion per RECIST v1.1;
- ECOG performance score of 0-1;
- Life expectancy ≥ 3 months;
- Adequate bone marrow and organ function.
Who cannot join
- Subjects with active central nervous system metastases or meningeal metastases;
- History of serious cardiovascular and cerebrovascular diseases;
- Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis;
- Severe infection within 4 weeks prior to the first dose;
- Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug;
- Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.
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 Dongfang Hospital
Shanghai, Shanghai Municipality, 200433
Caicun Zhou, +86-021-38804518, Caicunzhoudr@163.com
Caicun Zhou
About this study
Official title: A Phase I/II, Multicenter, Open-Label Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-1681 for Injection in Patients With Malignant Solid Tumors
This study is an open-label, multicenter Phase I/II clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-1681 for injection in patients with advanced solid tumors.
- Conditions
- Malignant Solid Tumors
- Being tested
- SHR-1681
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1681Drug
SHR-1681 for Injection will be administrated per dose level in which the patients are assigned.
| Study group | Role | What they receive |
|---|---|---|
| SHR-1681 | Experimental | Not described Receives: Drug: SHR-1681 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
Measured: 12 months.
Maximum administered dose (MAD)
Measured: 12 months.
Recommended Phase 2 dose (RP2D)
Measured: 12 months.
Incidence and severity of adverse events (AEs)
Measured: Approximately 3 years.
Incidence and severity of serious adverse events (SAEs)
Measured: Approximately 3 years.
Secondary outcomes (10)
Time to maximum concentration (Tmax) of SHR-1681
Measured: Approximately 3 years.
Maximum concentration (Cmax) of SHR-1681
Measured: Approximately 3 years.
Area under the concentration-time curve from time 0 to the last measurable concentration time point (AUC0-t) of SHR-1681
Measured: Approximately 3 years.
Area under the concentration-time curve from time 0 to infinity (AUC0-∞) of SHR-1681
Measured: Approximately 3 years.
Anti-SHR-1681 antibody (ADA) of SHR-1681
Measured: Approximately 3 years.
Overall response rate (ORR)
Measured: Approximately 3 years.
Duration of response (DoR)
Measured: Approximately 3 years.
Disease control rate (DCR)
Measured: Approximately 3 years.
Progression-free survival (PFS)
Measured: Approximately 3 years.
Overall survival (OS)
Measured: Approximately up to 5 years after the last subject enrolled.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start21 Jan 2025
- Primary completionNov 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant 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
- Masking
- None (open label)
- Enrolment
- 300 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
- NCT06737731
- Sponsor's protocol ID
- SHR-1681-101
- Status last verified
- Jan 2026
- First submitted
- 12 Dec 2024
- Last updated
- 9 Jan 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 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Multicenter, Open-Label Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-1681 for Injection in Patients With Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT06737731
- Acronym / sponsor ID
- SHR-1681-101
- Conditions
- Malignant Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 17 Dec 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-1681 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
| Arm | Type | Receives |
|---|---|---|
| SHR-1681 | Experimental | Drug: SHR-1681 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;
- Subjects with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment, or standard treatment is not applicable currently;
- Have at least one measurable tumor lesion per RECIST v1.1;
- ECOG performance score of 0-1;
- Life expectancy ≥ 3 months;
Key exclusion criteria (6 listed)
- Subjects with active central nervous system metastases or meningeal metastases;
- History of serious cardiovascular and cerebrovascular diseases;
- Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis;
- Severe infection within 4 weeks prior to the first dose;
- Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug;
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-1681SHR-1681 for Injection will be administrated per dose level in which the patients are assigned. | Drug | SHR-1681 |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: 12 months.
Maximum administered dose (MAD)
Time frame: 12 months.
Recommended Phase 2 dose (RP2D)
Time frame: 12 months.
Incidence and severity of adverse events (AEs)
Time frame: Approximately 3 years.
Incidence and severity of serious adverse events (SAEs)
Time frame: Approximately 3 years.
10 secondary outcomes
Time to maximum concentration (Tmax) of SHR-1681
Time frame: Approximately 3 years.
Maximum concentration (Cmax) of SHR-1681
Time frame: Approximately 3 years.
Area under the concentration-time curve from time 0 to the last measurable concentration time point (AUC0-t) of SHR-1681
Time frame: Approximately 3 years.
Area under the concentration-time curve from time 0 to infinity (AUC0-∞) of SHR-1681
Time frame: Approximately 3 years.
Anti-SHR-1681 antibody (ADA) of SHR-1681
Time frame: Approximately 3 years.
Overall response rate (ORR)
Time frame: Approximately 3 years.
Duration of response (DoR)
Time frame: Approximately 3 years.
Disease control rate (DCR)
Time frame: Approximately 3 years.
Progression-free survival (PFS)
Time frame: Approximately 3 years.
Overall survival (OS)
Time frame: Approximately up to 5 years after the last subject enrolled.
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 9 Jan 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-1681 in people with Malignant 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 6 inclusion and 6 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 9 Jan 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 Fei Qiu (+86-0518-82342973, fei.qiu@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 (MTD) (time frame: 12 months.). The study lists 5 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 9 Jan 2026.