A Phase IB/II Clinical Study of SHR-A2009 for Injection in Combination With Other Antitumor Therapies in Patients With Advanced Solid Tumors
- 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.
- Short title
- 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
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Unknown
- Phase
- Phase 1/Phase 2
- Study type
- Interventional
- Completion date
- 2025-12-01
- First posted
- 2023-10-23
- Registry last updated
- 2023-10-23
- Primary completion date
- 2025-12-01
- Start date
- 2023-10-01
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Registry sponsor category
- Industry
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06092268
- ClinicalTrials.gov ID
- NCT06092268
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
Incidence of dose-limiting toxicity (DLT) (phase IB)
Timeframe: 21 days after the first dose was administered to each subject.
Objective Response Rate (ORR) (phase II).
Timeframe: 2 years
PK parameter: toxin-binding antibody of SHR-A2009
Timeframe: through study completion, an average of 2 years
PK parameter: total antibody of SHR-A2009
Timeframe: through study completion, an average of 2 years
PK parameter: free toxin of SHR-A2009
Timeframe: through study completion, an average of 2 years
Plasma concentration of Adebrelimab
Timeframe: through study completion, an average of 2 years
Immunogenicity of SHR-A2009 and Adebrelimab (Anti-SHR-A2009 antibody, anti- Adebrelimab antibody ) (Phase IB)
Timeframe: through study completion, an average of 2 years
Duration of response(DoR )
Timeframe: One year after the last subject was enrolled in the group
Progression Free Survival(PFS)
Timeframe: 2 years after the last subject was enrolled in the group
Objective response rate
Timeframe: 2 years after the last subject was enrolled in the group
overall survival (OS) (phase IB)
Timeframe: 3 years after the last subject was enrolled in the group
Incidence of AEs（Phase II (efficacy expansion phase)）
Timeframe: from Day1 to 90 days after last dose
Incidence of SAEs（Phase II (efficacy expansion phase)）
Timeframe: from Day1 to 90 days after last dose
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Healthy volunteers
- No
- Age 18 to 75 years old (inclusive), Female or male
- Subjects with unresectable locally advanced or metastatic non-small cell lung cancer confirmed by histology or cytology
- Previously treated by EGFR-TKI or other standard treatment or have not been treated for metastatic setting;
- 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)
- ECOG performance score of 0-1;
- Expected survival time ≥ 12 weeks;
- Adequate bone marrow and organ function
- Subjects are required to give informed consent for this study prior to the trial and voluntarily sign a written informed consent form.
- Subjects with active central nervous system (CNS) metastases.
- Spinal cord compression not cured by surgery and/or radiotherapy cannot be enrolled.
- Subjects with uncontrolled tumor-related pain
- Clinically uncontrollable third space fluid
- Received antitumor therapy such as chemotherapy within 4 weeks prior to the first dose of study drug;
- Received >30 Gy of non-thoracic radical radiation therapy within 4 weeks prior to the first administration of study drug;
- Major organ surgery or significant trauma within 4 weeks prior to first use of study drug;
- Concomitant other malignancies ≤ 5 years prior to first dose of study drug;
- 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
- Serious cardiovascular disease
- Presence of refractory nausea, vomiting, chronic gastrointestinal disease, etc.; subjects with active, known or suspected autoimmune diseases
- Presence of severe infection within 4 weeks prior to first dose of study drug
- Subjects with clinically significant bleeding symptoms within 3 months prior to the first dose of study drug
- Arterial/venous thrombotic events within 3 months prior to the first study dose
- History of immunodeficiency, including a positive HIV test
- Presence of active hepatitis B or C;
- History of severe allergic reactions to other monoclonal antibodies or allergic reactions to any component of the SHR-A2009 product.
- Known history of alcohol or drug dependence or addiction;
- Persons with mental disorders or poor compliance;