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

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.

Study Overview

• Status: Recruiting
• Conditions: Malignant Solid Tumors
• Intervention / Treatment: Drug: SHR-1681

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Ting Lu, M.M; Phone Number: +86-18825721498; Email: ting.lu@hengrui.com
• Study Contact Backup: Name: Fei Qiu; Phone Number: +86-0518-82342973; Email: fei.qiu@hengrui.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200433
      • Recruiting
      • Shanghai Dongfang Hospital
      • Principal Investigator: Caicun Zhou
      • Contact: Caicun Zhou; Phone Number: +86-021-38804518; Email: Caicunzhoudr@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;
2. 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;
3. Have at least one measurable tumor lesion per RECIST v1.1;
4. ECOG performance score of 0-1;
5. Life expectancy ≥ 3 months;
6. Adequate bone marrow and organ function.

Exclusion Criteria:

1. Subjects with active central nervous system metastases or meningeal metastases;
2. History of serious cardiovascular and cerebrovascular diseases;
3. Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis;
4. Severe infection within 4 weeks prior to the first dose;
5. Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug;
6. Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-1681	Drug: SHR-1681; SHR-1681 for Injection will be administrated per dose level in which the patients are assigned.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum tolerated dose (MTD)	12 months.
Maximum administered dose (MAD)	12 months.
Recommended Phase 2 dose (RP2D)	12 months.
Incidence and severity of adverse events (AEs)	Approximately 3 years.
Incidence and severity of serious adverse events (SAEs)	Approximately 3 years.

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to maximum concentration (Tmax) of SHR-1681	Approximately 3 years.
Maximum concentration (Cmax) of SHR-1681	Approximately 3 years.
Area under the concentration-time curve from time 0 to the last measurable concentration time point (AUC0-t) of SHR-1681	Approximately 3 years.
Area under the concentration-time curve from time 0 to infinity (AUC0-∞) of SHR-1681	Approximately 3 years.
Anti-SHR-1681 antibody (ADA) of SHR-1681	Approximately 3 years.
Overall response rate (ORR)	Approximately 3 years.
Duration of response (DoR)	Approximately 3 years.
Disease control rate (DCR)	Approximately 3 years.
Progression-free survival (PFS)	Approximately 3 years.
Overall survival (OS)	Approximately up to 5 years after the last subject enrolled.

Collaborators and Investigators

• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: December 12, 2024
• First Submitted That Met QC Criteria: December 12, 2024
• First Posted (Actual): December 17, 2024

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: SHR-1681-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No