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

NCT06737731 | Recruiting Phase 1

• 1 other identifier: SHR-1681-101
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Solid Tumors

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (10)

• 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.

Study Arms (1)

SHR-1681

EXPERIMENTAL

Drug: SHR-1681

Interventions

SHR-1681 DRUG

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

SHR-1681

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Shanghai Dongfang Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Central Study Contacts

Fei Qiu

CONTACT

+86-0518-82342973; fei.qiu@hengrui.com

Ting Lu, M.M

CONTACT

+86-18825721498; ting.lu@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 17, 2024
• Study Start: January 21, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: January 9, 2026

Record last verified: 2026-01

Locations

CN (1)