Clinical trial NCT06092268: A Phase IB/II Clinical Study of SHR-A2009 for Injection in Combination With Other Antitumor Therapies in Patients With Advanced Solid Tumors
Official title: A Phase IB/II, Open-Label, Multicentre Clinical Study to Evaluate the Safety, Tolerability and Efficacy of SHR-A2009 for Injection in Combination With Other Therapies in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumors
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-10-23
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is an open-label, multicenter Phase IB/II clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-A2009 for injection in combination with other antitumor therapies in patients with advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

1. Age 18 to 75 years old (inclusive), Female or male
2. Subjects with unresectable locally advanced or metastatic non-small cell lung cancer confirmed by histology or cytology
3. Previously treated by EGFR-TKI or other standard treatment or have not been treated for metastatic setting;
4. At least one measurable tumor lesion according to RECIST v1.1 (enrollment of subjects with only non-target lesions is permitted in Stage IB phase)
5. ECOG performance score of 0-1;
6. Expected survival time ≥ 12 weeks;
7. Adequate bone marrow and organ function
8. Subjects are required to give informed consent for this study prior to the trial and voluntarily sign a written informed consent form.

Exclusion Criteria:

1. Subjects with active central nervous system (CNS) metastases.
2. Spinal cord compression not cured by surgery and/or radiotherapy cannot be enrolled.
3. Subjects with uncontrolled tumor-related pain
4. Clinically uncontrollable third space fluid
5. Received antitumor therapy such as chemotherapy within 4 weeks prior to the first dose of study drug;
6. Received \>30 Gy of non-thoracic radical radiation therapy within 4 weeks prior to the first administration of study drug;
7. Major organ surgery or significant trauma within 4 weeks prior to first use of study drug;
8. Concomitant other malignancies ≤ 5 years prior to first dose of study drug;
9. Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis; or other moderate-to-severe lung disease that severely affects lung function
10. Serious cardiovascular disease
11. Presence of refractory nausea, vomiting, chronic gastrointestinal disease, etc.; subjects with active, known or suspected autoimmune diseases
12. Presence of severe infection within 4 weeks prior to first dose of study drug
13. Subjects with clinically significant bleeding symptoms within 3 months prior to the first dose of study drug
14. Arterial/venous thrombotic events within 3 months prior to the first study dose
15. History of immunodeficiency, including a positive HIV test
16. Presence of active hepatitis B or C;
17. History of severe allergic reactions to other monoclonal antibodies or allergic reactions to any component of the SHR-A2009 product.
18. Known history of alcohol or drug dependence or addiction;
19. Persons with mental disorders or poor compliance;

Primary outcomes:
measure: Incidence of dose-limiting toxicity (DLT) (phase IB)
timeFrame: 21 days after the first dose was administered to each subject.
measure: Objective Response Rate (ORR) (phase II).
timeFrame: 2 years
Secondary outcomes:
measure: PK parameter: toxin-binding antibody of SHR-A2009
timeFrame: through study completion, an average of 2 years
measure: PK parameter: total antibody of SHR-A2009
timeFrame: through study completion, an average of 2 years
measure: PK parameter: free toxin of SHR-A2009
timeFrame: through study completion, an average of 2 years
measure: Plasma concentration of Adebrelimab
timeFrame: through study completion, an average of 2 years
measure: Immunogenicity of SHR-A2009 and Adebrelimab (Anti-SHR-A2009 antibody, anti- Adebrelimab antibody ) (Phase IB)
timeFrame: through study completion, an average of 2 years
measure: Duration of response(DoR )
timeFrame: One year after the last subject was enrolled in the group
measure: Progression Free Survival(PFS)
timeFrame: 2 years after the last subject was enrolled in the group
measure: Objective response rate
timeFrame: 2 years after the last subject was enrolled in the group
measure: overall survival (OS) (phase IB)
timeFrame: 3 years after the last subject was enrolled in the group
measure: Incidence of AEs（Phase II (efficacy expansion phase)）
timeFrame: from Day1 to 90 days after last dose
measure: Incidence of SAEs（Phase II (efficacy expansion phase)）
timeFrame: from Day1 to 90 days after last dose
Other outcomes:
Locations:
Study officials:
References: