Study of SHR-A1921 in Combination With Other Anti-cancer Agents in Patients With Advanced Solid Tumors

Suzhou Suncadia Biopharmaceuticals

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: SHR-A1921；

Study type: Interventional

Funder types: Industry

Identifiers

NCT05765032

SHR-A1921-201

Details and patient eligibility

About

This research study is a multicentre phase Ⅰb/Ⅱ Study to evaluate the efficacy and safety of SHR-A1921 in combination with other anti-cancer agents in patients with advanced solid tumors

Enrollment: 220 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female, 18-75 years;
2. Be able to provide fresh or archived tumour tissue.
3. Ph 1b: clinically or pathologically diagnosed advanced solid tumour . Ph II: Histologically or cytologically confirmed, advanced or metastatic non-small cell lung cancer
4. With at least one measurable lesion (in accordance with RECIST v1.1)
5. Eastern Cooperative Oncology Group (ECOG) score: 0-1.
6. With a life expectancy ≥ 12 weeks.
7. Sufficient organ functions.
8. Women of childbearing potential (WOCBP) and Male subjects whose partner are women of childbearing potential must agree to use a reliable and valid contraceptive method.

Exclusion criteria

1. Untreated brain metastasis or accompanied by meningeal metastases, spinal cord compression.
2. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms.
3. Previous or co-existing malignancies other than cured basal cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of the breast (DCIS), papillary thyroid carcinoma, and other malignancies that have been adequately treated and cured for ≥3 years
4. Hypertension that can not be well controlled through antihypertensive drugs (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg); previous hypertensive crisis or hypertensive encephalopathy.
5. with any active or known autoimmune disease
6. with active pulmonary tuberculosis infection

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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220 participants in 1 patient group

SHR-A1921

Experimental group

Description:

A1：SHR-A1921+Adebrelimab A2：SHR-A1921+Carboplatin A3：SHR-A1921+Cisplatin A4：SHR-A1921+Bevacizumab A5：SHR-A1921+Adebrelimab+Carboplatin A6：SHR-A1921+Adebrelimab+Cisplatin B1：SHR-A1921+Adebrelimab B2：SHR-A1921+Adebrelimab+Carboplatin/Cisplatin

Treatment:

Drug: SHR-A1921；