Phase I Study of SHR-2022 Injection in the Treatment of Patients With Advanced Malignant Tumors

NCT06131216 | Not Yet Recruiting Phase 1

• 1 other identifier: SHR-2022-I-101
• Study Type: interventional
• Target: 116
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the safety and tolerability of SHR-2022 in patients with advanced malignancies and to determine MTD or MAD versus RP2D

Conditions

Advanced Malignant Cancer

Outcome Measures

Primary Outcomes (4)

• Incidence of adverse events

  up to 3 years

• Severity of adverse events

  up to 3 years

• MTD

  up to 3 years

• RP2D

  up to 3 years

Secondary Outcomes (5)

• Time to maximum concentration (Tmax)

  up to 3 year

• Maximum concentration (Cmax)

  up to 3 year

• Receptor Occupancy（OR） of SHR-2022

  up to 3 year

• Anti-drug antibody (ADA) of SHR-2022

  up to 3 year

• Objective response rate (ORR)

  up to 3 year

Study Arms (1)

SHR-2022 Injection

EXPERIMENTAL

Drug: SHR-2022 Injection

Interventions

SHR-2022 Injection DRUG

SHR-2022 Injection is administered by intravenous (IV) infusion

SHR-2022 Injection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary participation in this study, signed informed consent, compliance is good, can cooperate with follow-up
• Age 18-80 years old (including both ends), both male and female
• Subjects with advanced or metastatic malignant tumors confirmed by pathological tissue or cytology, and who have failed previous standard treatments, are intolerant to standard treatments, or have no standard treatments
• Have measurable lesions
• ECOG PS score: 0-1
• Have a life expectancy of at least 3 months
• 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, diagnostic or superficial surgery was performed within 7 days prior to the initial study, or elective surgery was expected during the trial period
• Received within 28 days prior to the first investigational dose Non-radical chest radiation therapy of 30Gy received within 24 weeks prior to initial dosing. Patients receiving 30Gy of chest radiation therapy, and those receiving palliative radiation ≤30Gy within 14 days prior to the first dose
• The AE caused by previous anti-tumor therapy did not recover to CTCAE v5.0 grade evaluation ≤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
• Accompanied by interstitial pneumonia or interstitial lung disease
• Patients with a history of autoimmune disease
• The first study studied patients with clinically significant bleeding symptoms or bleeding tendency within 3 months before medication
• The first study was conducted in subjects with severe cardiovascular and cerebrovascular disease within 6 months prior to medication
• Arterial/venous thrombosis events occurred within 3 months prior to initial administration

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Central Study Contacts

Yanbo Liu

CONTACT

0518-82342973; yanbo.liu@hengrui.com

Zhenqun Lu

CONTACT

0518-82342973; 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

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 14, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 14, 2023

Record last verified: 2023-11