RecruitingNCT06737731Updated Jan 9, 2026

A Phase I/II Clinical Study of SHR-1681 for Injection in Patients With Advanced Solid Tumors

A Phase 1/2 interventional study of SHR-1681 in Malignant Solid Tumors, sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-09.

Sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Phase 1/2, Interventional, and Treatment

From the registry’s dates

Started Jan 2025; still recruiting 1 year 8 months later.

Phase: Phase 1/2
Study type: Interventional
Enrollment: 300
Allocation: Not applicable
Ages: 18 Years to 75 Years
Sex: All

Study 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.

Conditions studied

Malignant Solid Tumors

In context

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd. is the lead sponsor of 100 studies on the registry; 69 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 300 participants (estimated)

Study arms

Experimental
SHR-1681
Drug: SHR-1681

Interventions

DrugSHR-1681
SHR-1681 for Injection will be administrated per dose level in which the patients are assigned.

What researchers measure

Primary outcomes

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.

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.

Study locations

1 of 1 sites recruiting

Shanghai Dongfang Hospital
Shanghai, Shanghai Municipality 200433, China
- Caicun Zhou · Contact · Caicunzhoudr@163.com · +86-021-38804518
- Caicun Zhou · Principal investigator
Recruiting

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06737731
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Responsible party: Sponsor
First posted: Dec 17, 2024
Start date: Jan 21, 2025
Primary completion: Nov 2026 (estimated)
Completion: Jul 2027 (estimated)
Last update: Jan 9, 2026

Study contacts

Fei Qiu

Contact

fei.qiu@hengrui.com

+86-0518-82342973

Ting Lu, M.M

Contact

ting.lu@hengrui.com

+86-18825721498

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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