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Active, not recruitingNCT05765032Updated Sep 26, 2024

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

A Phase 1/2 interventional study of SHR-A1921； in Advanced Solid Tumor, sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-09-26.

Sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 5 months ago, but the record still lists the study as active, not recruiting.
Phase
Phase 1/2
Study type
Interventional
Enrollment
220
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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

02

Conditions studied

  • Advanced Solid Tumor

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 220 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd. is the lead sponsor of 100 studies on the registry; 69 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
220 participants (actual)

Study arms

  • 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；

Interventions

  • DrugSHR-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

06

What researchers measure

Primary outcomes

  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 outcomes

  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.

07

Study locations

1 site
  • Tianjin Medical University Cancer Institute& Hospital
    Tianjin, Tianjin 300060, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05765032
Lead sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Responsible party
Sponsor
First posted
Mar 13, 2023
Start date
Dec 30, 2022
Primary completion
Apr 30, 2025 (estimated)
Completion
Feb 28, 2026 (estimated)
Last update
Sep 26, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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