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

Advanced Solid Tumor Clinical Trial

Official title:

An Open Label, Multicenter, Phase Ib/II Study of SHR-A1921 in Combination With Other Anti-cancer Agents in Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05765032
• Other study ID #: SHR-A1921-201
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 30, 2022
• Est. completion date: February 28, 2026

Study information

• Verified date: February 2023
• Source: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
• Contact: Yongli Xie
• Phone: 0518-82342973
• Email: yongli.xie[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: February 28, 2026
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• SHR-A1921;
Drug: SHR-A1921 administered as an IV infusion Drug: Adebrelimab administered as an IV infusion Drug: Carboplatin administered as an IV infusion Drug: Cisplatin administered as an IV infusion Drug: Bevacizumab administered as an IV infusion

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute& Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects Experienced Any Dose-Limiting Toxicity (DLT) over the DLT period. (Phase 1b)		up to 21 days of cycle 1
Primary	Determination of Recommended Phase II dose (RP2D) (Phase 1b)		Up to 21 days of cycle 1
Primary	Objective Response Rate as Assessed by the Investigator according to RECIST v1.1(Phase II)		From baseline to progressive disease or death (approximately 1 year)
Secondary	Objective Response Rate as Assessed by the Investigator according to RECIST v1.1e (Ph1b only),		From baseline to progressive disease or death (approximately 1 year)]
Secondary	Duration of Response as Assessed by the Investigator according to RECIST v1.1		From baseline to progressive disease or death (approximately 1 year)
Secondary	Disease Control Rate as Assessed by the Investigator according to RECIST v1.1		From baseline to progressive disease or death (approximately 1 year)
Secondary	Time to Response as Assessed by the Investigator according to RECIST v1.1		From baseline to progressive disease or death (approximately 1 year)
Secondary	Progression-free Survival as Assessed by the Investigator according to RECIST v1.1		From baseline to progressive disease or death (approximately 1 year)
Secondary	Overall survival		approximately 12months after last patient enrolled.