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Not yet recruitingNCT06092268Updated Oct 23, 2023

A Phase IB/II Clinical Study of SHR-A2009 for Injection in Combination With Other Antitumor Therapies in Patients With Advanced Solid Tumors

A Phase 1/2 interventional study of SHR-A2009 for injection ； Almonertinib Mesilate Tablets and SHR-A2009 for injection；Adebrelimab Injection in Advanced Solid Tumors, sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-10-23.

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

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 1/2
Study type
Interventional
Enrollment
270
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This study is an open-label, multicenter Phase IB/II clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-A2009 for injection in combination with other antitumor therapies in patients with advanced solid tumors.

02

Conditions studied

  • Advanced Solid Tumors

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03

In context

Neoplasms

9,359 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.

This study's planned enrollment of 270 is above the median of 50 across 7,250 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.

04

Who can participate

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

Inclusion criteria

  1. Age 18 to 75 years old (inclusive), Female or male
  2. Subjects with unresectable locally advanced or metastatic non-small cell lung cancer confirmed by histology or cytology
  3. Previously treated by EGFR-TKI or other standard treatment or have not been treated for metastatic setting;
  4. At least one measurable tumor lesion according to RECIST v1.1 (enrollment of subjects with only non-target lesions is permitted in Stage IB phase)
  5. ECOG performance score of 0-1;
  6. Expected survival time ≥ 12 weeks;
  7. Adequate bone marrow and organ function
  8. Subjects are required to give informed consent for this study prior to the trial and voluntarily sign a written informed consent form.

Exclusion criteria

Exclusion Criteria:

  1. Subjects with active central nervous system (CNS) metastases.
  2. Spinal cord compression not cured by surgery and/or radiotherapy cannot be enrolled.
  3. Subjects with uncontrolled tumor-related pain
  4. Clinically uncontrollable third space fluid
  5. Received antitumor therapy such as chemotherapy within 4 weeks prior to the first dose of study drug;
  6. Received >30 Gy of non-thoracic radical radiation therapy within 4 weeks prior to the first administration of study drug;
  7. Major organ surgery or significant trauma within 4 weeks prior to first use of study drug;
  8. Concomitant other malignancies ≤ 5 years prior to first dose of study drug;
  9. Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis; or other moderate-to-severe lung disease that severely affects lung function
  10. Serious cardiovascular disease
  11. Presence of refractory nausea, vomiting, chronic gastrointestinal disease, etc.; subjects with active, known or suspected autoimmune diseases
  12. Presence of severe infection within 4 weeks prior to first dose of study drug
  13. Subjects with clinically significant bleeding symptoms within 3 months prior to the first dose of study drug
  14. Arterial/venous thrombotic events within 3 months prior to the first study dose
  15. History of immunodeficiency, including a positive HIV test
  16. Presence of active hepatitis B or C;
  17. History of severe allergic reactions to other monoclonal antibodies or allergic reactions to any component of the SHR-A2009 product.
  18. Known history of alcohol or drug dependence or addiction;
  19. Persons with mental disorders or poor compliance;
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
270 participants (estimated)

Study arms

  • Experimental
    Treatment Part A: SHR-A2009 for injection in combination with Almonertinib Mesilate Tablets

    Drug: SHR-A2009 for injection ； Almonertinib Mesilate Tablets

  • Experimental
    Treatment Part B: SHR-A2009 for injection in combination with Adebrelimab Injection

    Drug: SHR-A2009 for injection；Adebrelimab Injection

Interventions

  • DrugSHR-A2009 for injection ； Almonertinib Mesilate Tablets

    Phase IB: SHR-A2009 will be administered intravenously，Almonertinib Mesilate Tablets will be administered orally. 2 or 3 dose levels are preset in phase IB. Phase II: 2 dose cohorts will be selected and it's randomization.

  • DrugSHR-A2009 for injection；Adebrelimab Injection

    Phase IB: SHR-A2009 and Adebrelimab will be administered intravenously. 2 dose levels are preset in phase IB. Phase II: RPD2 will be selected to evaluate preliminary efficacy.

06

What researchers measure

Primary outcomes

  1. Incidence of dose-limiting toxicity (DLT) (phase IB)

    Time frame: 21 days after the first dose was administered to each subject.

  2. Objective Response Rate (ORR) (phase II).

    Time frame: 2 years

Secondary outcomes

  1. PK parameter: toxin-binding antibody of SHR-A2009

    Time frame: through study completion, an average of 2 years

  2. PK parameter: total antibody of SHR-A2009

    Time frame: through study completion, an average of 2 years

  3. PK parameter: free toxin of SHR-A2009

    Time frame: through study completion, an average of 2 years

  4. Plasma concentration of Adebrelimab

    Time frame: through study completion, an average of 2 years

  5. Immunogenicity of SHR-A2009 and Adebrelimab (Anti-SHR-A2009 antibody, anti- Adebrelimab antibody ) (Phase IB)

    Time frame: through study completion, an average of 2 years

  6. Duration of response(DoR )

    Time frame: One year after the last subject was enrolled in the group

  7. Progression Free Survival(PFS)

    Time frame: 2 years after the last subject was enrolled in the group

  8. Objective response rate

    Time frame: 2 years after the last subject was enrolled in the group

  9. overall survival (OS) (phase IB)

    Time frame: 3 years after the last subject was enrolled in the group

  10. Incidence of AEs（Phase II (efficacy expansion phase)）

    Time frame: from Day1 to 90 days after last dose

  11. Incidence of SAEs（Phase II (efficacy expansion phase)）

    Time frame: from Day1 to 90 days after last dose

07

Study locations

No study locations are listed for this record.

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 Oct 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06092268
Lead sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Responsible party
Sponsor
First posted
Oct 23, 2023
Start date
Oct 2023 (estimated)
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Oct 23, 2023

Study contacts

Fei Qiu
Contact
fei.qiu@hengrui.com
0518-82342973

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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