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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05765032
Recruitment Status : Not yet recruiting
First Posted : March 13, 2023
Last Update Posted : March 13, 2023
Sponsor:
Information provided by (Responsible Party):
Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: SHR-A1921； Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : March 1, 2023
Estimated Primary Completion Date : April 30, 2025
Estimated Study Completion Date : February 28, 2026
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Number of Subjects Experienced Any Dose-Limiting Toxicity (DLT) over the DLT period. （Phase 1b） [ Time Frame: up to 21 days of cycle 1 ]
  2. Determination of Recommended Phase II dose (RP2D) （Phase 1b） [ Time Frame: Up to 21 days of cycle 1 ]
  3. Objective Response Rate as Assessed by the Investigator according to RECIST v1.1（Phase II） [ Time Frame: From baseline to progressive disease or death (approximately 1 year) ]

Secondary Outcome Measures :
  1. Objective Response Rate as Assessed by the Investigator according to RECIST v1.1e (Ph1b only), [ Time Frame: From baseline to progressive disease or death (approximately 1 year)] ]
  2. Duration of Response as Assessed by the Investigator according to RECIST v1.1 [ Time Frame: From baseline to progressive disease or death (approximately 1 year) ]
  3. Disease Control Rate as Assessed by the Investigator according to RECIST v1.1 [ Time Frame: From baseline to progressive disease or death (approximately 1 year) ]
  4. Time to Response as Assessed by the Investigator according to RECIST v1.1 [ Time Frame: From baseline to progressive disease or death (approximately 1 year) ]
  5. Progression-free Survival as Assessed by the Investigator according to RECIST v1.1 [ Time Frame: From baseline to progressive disease or death (approximately 1 year) ]
  6. Overall survival [ Time Frame: approximately 12months after last patient enrolled. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05765032


Contacts
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Contact: Yongli Xie 0518-82342973 yongli.xie@hengrui.com
Contact: Peng Xiu 0518-82342973 peng.xiu@hengrui.com

Sponsors and Collaborators
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
More Information
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Responsible Party: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT05765032    
Other Study ID Numbers: SHR-A1921-201
First Posted: March 13, 2023    Key Record Dates
Last Update Posted: March 13, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms