A Clinical Study of SHR-3276 for Injection in Patients With Advanced Malignant Tumors

A Phase I/II Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-3276 Injection in Patients With Advanced Malignant Tumors

This study is an open-label, multicenter Phase I/II clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-3276 for injection in patients with advanced solid tumors.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: SHR-3276

• Study Type: Interventional
• Enrollment (Estimated): 115
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Zhenqun Lu; Phone Number: +0518-81220121; Email: zhenqun.lu@hengrui.com

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400037
      • Recruiting
      • The Second Affiliated Hospital of PLA Army Medical University
      • Contact: Bo Zhu

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Able and willing to sign a written informed consent；
2. Age 18-70 years old (including both ends), both male and female；
3. Pathologically confirmed advanced malignant tumors that have failed sufficient standard treatment or have no effective standard treatment plan；
4. Existence of measurable lesions；
5. ECOG score: 0-1；
6. Expected survival time ≥ 12 weeks；
7. The functional level of the major organs must meet the requirements；
8. Fertile female patients must have a serum pregnancy test within 7 days before the first medication and the result is negative; And must be non-lactating.

Exclusion Criteria:

1. Central nervous system metastasis or meningeal metastasis with clinical symptoms;
2. Spinal cord compression that has not been treated radically by surgery and/or radiotherapy；
3. Patients with uncontrolled tumor-related pain as judged by the investigator
4. A third space effusion with uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion, as determined by the investigator；
5. Systemic antitumor therapy was administered within 28 days prior to treatment in the first study；
6. Surgical procedures requiring tracheal intubation and general anesthesia were performed within 28 days prior to the initial study, or elective surgery was expected during the trial period；
7. Serious drug-related adverse reactions during previous immune checkpoint inhibitor therapy；
8. Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤ 1；
9. Live attenuated vaccines were used within 28 days prior to administration in the first study or were expected to be required during the study treatment；
10. Systemic immunosuppressive therapy was administered within 14 days prior to the first study
11. Arterial/venous thrombosis events occurred within 3 months prior to initial administration
12. Patients with clinical significant lung disease;
13. Patients with history of autoimmune diseases;
14. The first study studied any other malignancy within 5 years prior to medication
15. A known history of severe allergic reactions to the investigational drug and its principal formulation ingredients；
16. Have a history of immune deficiency or organ transplantation；
17. Other serious accompanying illnesses, which, in the investigator's assessment, could seriously adversely affect the safety of the treatment.

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-3276 for Injection will be administrated per dose level in which the patients are assigned.	Drug: SHR-3276; Dose Escalation: SHR-3276 will be administered intravenously. 4 dose levels are preset. Dose Expansion: 2 to 3 dose cohorts will be selected for dose expansion stage. Indication Expansion: Indications will be selected to evaluate preliminary efficacy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence and severity of adverse events	up to 3 years
MTD	up to 6 months
RP2D	up to 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to maximum concentration (Tmax)	up to 3 years
Maximum concentration (Cmax)	up to 3 years
Receptor Occupancy（OR） of SHR-3276	up to 3 years
Anti-drug antibody (ADA) of SHR-3276	up to 3 years
Objective response rate (ORR)	From date of administration until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years
Duration of response (DoR)	From date of administration until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years
Disease control rate (DCR)	From date of administration until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years
Progression free survival（PFS）	From date of administration until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years
Overall survival (OS)	From date of administration until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years

Collaborators and Investigators

• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2024
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2028

Study Registration Dates

• First Submitted: October 14, 2024
• First Submitted That Met QC Criteria: October 14, 2024
• First Posted (Actual): October 16, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 6, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: SHR-3276-101

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