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

NCT06643754 | Recruiting Phase 1

• 1 other identifier: SHR-3276-101
• Study Type: interventional
• Target: 115
• 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-3276 for injection in patients with advanced solid tumors.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

• Incidence and severity of adverse events

  up to 3 years

• MTD

  up to 6 months

• RP2D

  up to 1 year

Secondary Outcomes (9)

• 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

Study Arms (1)

SHR-3276 for Injection will be administrated per dose level in which the patients are assigned.

EXPERIMENTAL

Drug: SHR-3276

Interventions

SHR-3276 DRUG

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.

SHR-3276 for Injection will be administrated per dose level in which the patients are assigned.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to sign a written informed consent；
• Age 18-70 years old (including both ends), both male and female；
• Pathologically confirmed advanced malignant tumors that have failed sufficient standard treatment or have no effective standard treatment plan；
• Existence of measurable lesions；
• ECOG score: 0-1；
• Expected survival time ≥ 12 weeks；
• The functional level of the major organs must meet the requirements；
• 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.

You may not qualify if:

• Central nervous system metastasis or meningeal metastasis with clinical symptoms;
• Spinal cord compression that has not been treated radically by surgery and/or radiotherapy；
• Patients with uncontrolled tumor-related pain as judged by the investigator
• A third space effusion with uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion, as determined by the investigator；
• Systemic antitumor therapy was administered within 28 days prior to treatment in the first study；
• 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；
• Serious drug-related adverse reactions during previous immune checkpoint inhibitor therapy；
• Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤ 1；
• 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；
• Systemic immunosuppressive therapy was administered within 14 days prior to the first study
• Arterial/venous thrombosis events occurred within 3 months prior to initial administration
• Patients with clinical significant lung disease;
• Patients with history of autoimmune diseases;
• The first study studied any other malignancy within 5 years prior to medication
• A known history of severe allergic reactions to the investigational drug and its principal formulation ingredients；

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

The Second Affiliated Hospital of PLA Army Medical University

Chongqing, Chongqing Municipality, 400037, China

RECRUITING

Central Study Contacts

Zhenqun Lu

CONTACT

+0518-81220121; zhenqun.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

Model Details: Single arm study of SHR-3276

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 16, 2024
• Study Start: December 10, 2024
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2028
• Last Updated: January 8, 2025

Record last verified: 2024-10

Locations

CN (1)