Clinical trial NCT06643754: A Clinical Study of SHR-3276 for Injection in Patients With Advanced Malignant Tumors
Official title: A Phase I/II Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-3276 Injection in Patients With Advanced Malignant Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumors
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-10-16
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm study of SHR-3276
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence and severity of adverse events
timeFrame: up to 3 years
measure: MTD
timeFrame: up to 6 months
measure: RP2D
timeFrame: up to 1 year
Secondary outcomes:
measure: Time to maximum concentration (Tmax)
timeFrame: up to 3 years
measure: Maximum concentration (Cmax)
timeFrame: up to 3 years
measure: Receptor Occupancy（OR） of SHR-3276
timeFrame: up to 3 years
measure: Anti-drug antibody (ADA) of SHR-3276
timeFrame: up to 3 years
measure: Objective response rate (ORR)
timeFrame: 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
measure: Duration of response (DoR)
timeFrame: 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
measure: Disease control rate (DCR)
timeFrame: 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
measure: Progression free survival（PFS）
timeFrame: 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
measure: Overall survival (OS)
timeFrame: 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
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The Second Affiliated Hospital of PLA Army Medical University
state: Chongqing
Study officials:
References: