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

Phase 1

Recruiting

• Conditions: Malignant Solid Tumors
• Interventions: Drug: SHR-1681

• Registration Number: NCT06737731
• Lead Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2024-12-12
• Study First Posted: 2024-12-17
• Study Start: 2025-01-21
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-22
• Primary Completion: 2026-11
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SHR-1681	SHR-1681	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Shanghai Dongfang Hospital; 🇨🇳 Shanghai, Shanghai, China