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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: SHR-A1921；

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Tianjin Medical University Cancer Institute& Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-A1921; 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Subjects Experienced Any Dose-Limiting Toxicity (DLT) over the DLT period. （Phase 1b）	up to 21 days of cycle 1
Determination of Recommended Phase II dose (RP2D) （Phase 1b）	Up to 21 days of cycle 1
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 Outcome Measures

Outcome Measure	Time Frame
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)]
Duration of Response as Assessed by the Investigator according to RECIST v1.1	From baseline to progressive disease or death (approximately 1 year)
Disease Control Rate as Assessed by the Investigator according to RECIST v1.1	From baseline to progressive disease or death (approximately 1 year)
Time to Response as Assessed by the Investigator according to RECIST v1.1	From baseline to progressive disease or death (approximately 1 year)
Progression-free Survival as Assessed by the Investigator according to RECIST v1.1	From baseline to progressive disease or death (approximately 1 year)
Overall survival	approximately 12months after last patient enrolled.

Collaborators and Investigators

• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2022
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: February 14, 2023
• First Submitted That Met QC Criteria: February 28, 2023
• First Posted (Actual): March 13, 2023

Study Record Updates

• Last Update Posted (Actual): September 26, 2024
• Last Update Submitted That Met QC Criteria: September 25, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: SHR-A1921-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No