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

Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-2022 Injection Alone or in Combination With Other Anti-tumor Treatments in Patients With Advanced Malignant Tumors

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

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Malignant Cancer
• Intervention / Treatment: Drug: SHR-2022 Injection

• Study Type: Interventional
• Enrollment (Estimated): 116
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yanbo Liu; Phone Number: 0518-82342973; Email: yanbo.liu@hengrui.com
• Study Contact Backup: Name: Zhenqun Lu; Phone Number: 0518-82342973; Email: zhenqun.lu@hengrui.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Voluntary participation in this study, signed informed consent, compliance is good, can cooperate with follow-up
2. Age 18-80 years old (including both ends), both male and female
3. 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
4. Have measurable lesions
5. ECOG PS score: 0-1
6. Have a life expectancy of at least 3 months
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, diagnostic or superficial surgery was performed within 7 days prior to the initial study, or elective surgery was expected during the trial period
7. 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
8. The AE caused by previous anti-tumor therapy did not recover to CTCAE v5.0 grade evaluation ≤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. Accompanied by interstitial pneumonia or interstitial lung disease
12. Patients with a history of autoimmune disease
13. The first study studied patients with clinically significant bleeding symptoms or bleeding tendency within 3 months before medication
14. The first study was conducted in subjects with severe cardiovascular and cerebrovascular disease within 6 months prior to medication
15. Arterial/venous thrombosis events occurred within 3 months prior to initial administration
16. The first study studied any other malignancy within 5 years prior to medication
17. A known history of severe allergic reactions to the investigational drug and its principal formulation ingredients
18. Have a history of immune deficiency or organ transplantation, and have active hepatitis B or C
19. Severe infection within 4 weeks prior to the first dose
20. Patients with active pulmonary tuberculosis within 1 year prior to enrollment were found by history or CT examination
21. The presence of other serious physical or mental illness, known alcohol or drug dependence, abnormal laboratory tests, and other factors that may increase the risk of participating in the study or interfere with the study results; And any other conditions that the investigator deems inappropriate for participation in this study

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events	up to 3 years
MTD	up to 3 years
RP2D	up to 3 years
Severity of adverse events	up to 3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 8, 2023
• First Submitted That Met QC Criteria: November 8, 2023
• First Posted (Estimated): November 14, 2023

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 8, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: SHR-2022-I-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