An Open Phase I Clinical Trial of SHR-1826 for Injection in Patients With Advanced Solid Tumors

NCT06094556 | Recruiting Phase 1

• 1 other identifier: SHR-1826-I-101
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open, multi-center, dose-escalation/dose-expansion/efficacy expansion phase I clinical study to evaluate the tolerability, safety, PK, and immunogenicity of SHR-1826 in patients with advanced malignant solid tumors, and to preliminatively observe its antitumor efficacy. The whole study was divided into three stages: dose increment, dose extension and therapeutic effect extension.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

• Dose-limiting toxicity

  evaluate the safety in the doses escalation

  21 Days

• Maximum tolerated dose or Maximum-administered dose

  evaluate the safety in the doses escalation

  Approximately 1 year

• Recommended Phase 2 dose (RP2D)

  evaluate the safety and curative effect in the doses escalation

  Approximately 2 years

Secondary Outcomes (14)

• Maximum concentration (Cmax) of SHR-1826

  Approximately 2 years

• Time to maximum concentration (Tmax) of SHR-1826

  Approximately 2 years

• Areas under the concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) of SHR-1826

  Approximately 2 years

• Areas under the concentration-time curve from time zero extrapolated to infinity (AUCinf) of SHR-1826

  Approximately 2 years

• Half-life (t1/2) of SHR-1826

  Approximately 2 years

Study Arms (1)

SHR-1826

EXPERIMENTAL

Dose escalation; Dose expansion; Therapeutic effect expansion.

Drug: SHR-1826

Interventions

SHR-1826 DRUG

dose is calculated based on the subjects' baseline weight.

SHR-1826

Eligibility Criteria

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

You may qualify if:

• Able and willing to provide a written informed consent.
• years old ，Male or female.
• ECOG score is 0 or 1.
• Subjects with advanced or metastatic solid tumors that have been documented by histopathology and are not responding to or tolerated by standard treatment, or have no effective standard treatment options.
• Have at least one measurable lesion according to RECIST v1.1 criteria.
• Expected survival ≥3 months .
• With good vital organ function.
• Contraception.

You may not qualify if:

• With untreated or active Central nervous system (CNS) tumor metastasis. Subjects with a history or current history of meningeal metastasis.
• Previous or co-existing malignant tumors.
• Spinal cord compression that was not treated radically by surgery and/or radiotherapy was excluded.
• Patients with uncontrolled tumor-related pain.
• Received systemic antitumor therapy 4 weeks before starting study treatment; Previously receiving small molecule targeted therapy, the interval of not less than 5 half-lives of the drug can be enrolled.
• Previously received antibody-coupled drug therapy.
• Have undergone major surgery other than diagnosis or biopsy within 28 days prior to initial dosing; Minor traumatic surgery within 7 days prior to first dosing.
• First study subjects receiving \>30Gy non-radical chest radiation within 28 days prior to administration, \>30Gy chest radiation within 24 weeks prior to first administration, and ≤30Gy palliative radiation within 14 days prior to first administration;If previously received radioisotope therapy, the interval of not less than 5 half-lives of the isotope drug can be included.
• Is participating in another clinical study or the time of first administration is less than 4 weeks from the end of the previous clinical study (last administration), or the 5 half-life of the investigational drug, whichever is the older.
• The AE caused by previous anti-tumor therapy did not recover to CTCAE v5.0 grade evaluation ≤1.
• Other severe lung diseases that may interfere with the detection or management of drug-related pulmonary toxicity within the first three months of administration that significantly affect respiratory function; Any autoimmune, connective tissue, or inflammatory disease with lung involvement; Prior left or right total lung resection.
• Pleural effusion, ascites, or pericardial effusion requiring intervention occurred within 2 weeks prior to the first dose.
• Have an active autoimmune disease, or other acquired (HIV infection), congenital immunodeficiency disease, or a history of organ transplantation.
• Have poorly controlled or severe cardiovascular disease.
• Known hereditary or acquired bleeding and thrombotic tendencies, and clinically significant bleeding symptoms and arterial/venous thrombosis events in the 3 months prior to the first dose.

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

RECRUITING

Central Study Contacts

Yijun Jia

CONTACT

+0518-81220121; yijun.jia@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: October 16, 2023
• First Posted: October 23, 2023
• Study Start: December 25, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: April 13, 2025

Record last verified: 2025-04

Locations

CN (1)