Advanced Solid TumorsPhase 1/2NCT06092268
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 study testing SHR-A2009 for injection ； Almonertinib Mesilate Tablets and SHR-A2009 for injection；Adebrelimab Injection in people with Advanced Solid Tumors, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- SHR-A2009 for injection ； Almonertinib Mesilate Tablets and SHR-A2009 for injection；Adebrelimab Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Dec 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75 years old (inclusive), Female or male
- Subjects with unresectable locally advanced or metastatic non-small cell lung cancer confirmed by histology or cytology
- Previously treated by EGFR-TKI or other standard treatment or have not been treated for metastatic setting;
- 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)
- ECOG performance score of 0-1;
- Expected survival time ≥ 12 weeks;
- Adequate bone marrow and organ function
- Subjects are required to give informed consent for this study prior to the trial and voluntarily sign a written informed consent form.
Who cannot join
- Subjects with active central nervous system (CNS) metastases.
- Spinal cord compression not cured by surgery and/or radiotherapy cannot be enrolled.
- Subjects with uncontrolled tumor-related pain
- Clinically uncontrollable third space fluid
- Received antitumor therapy such as chemotherapy within 4 weeks prior to the first dose of study drug;
- Received >30 Gy of non-thoracic radical radiation therapy within 4 weeks prior to the first administration of study drug;
Show all 19Show fewer
- Major organ surgery or significant trauma within 4 weeks prior to first use of study drug;
- Concomitant other malignancies ≤ 5 years prior to first dose of study drug;
- 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
- Serious cardiovascular disease
- Presence of refractory nausea, vomiting, chronic gastrointestinal disease, etc.; subjects with active, known or suspected autoimmune diseases
- Presence of severe infection within 4 weeks prior to first dose of study drug
- Subjects with clinically significant bleeding symptoms within 3 months prior to the first dose of study drug
- Arterial/venous thrombotic events within 3 months prior to the first study dose
- History of immunodeficiency, including a positive HIV test
- Presence of active hepatitis B or C;
- History of severe allergic reactions to other monoclonal antibodies or allergic reactions to any component of the SHR-A2009 product.
- Known history of alcohol or drug dependence or addiction;
- Persons with mental disorders or poor compliance;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase IB/II, Open-Label, Multicentre Clinical Study to Evaluate the Safety, Tolerability and Efficacy of SHR-A2009 for Injection in Combination With Other Therapies in Patients With Advanced Solid Tumors
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.
- Conditions
- Advanced Solid Tumors
- Being tested
- SHR-A2009 for injection ； Almonertinib Mesilate Tablets, SHR-A2009 for injection；Adebrelimab Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A2009 for injection ； Almonertinib Mesilate TabletsDrug
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.
SHR-A2009 for injection；Adebrelimab InjectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Part A: SHR-A2009 for injection in combination with Almonertinib Mesilate Tablets | Experimental | Not described Receives: Drug: SHR-A2009 for injection ； Almonertinib Mesilate Tablets |
| Treatment Part B: SHR-A2009 for injection in combination with Adebrelimab Injection | Experimental | Not described Receives: Drug: SHR-A2009 for injection；Adebrelimab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicity (DLT) (phase IB)
Measured: 21 days after the first dose was administered to each subject.
Objective Response Rate (ORR) (phase II).
Measured: 2 years
Secondary outcomes (11)
PK parameter: toxin-binding antibody of SHR-A2009
Measured: through study completion, an average of 2 years
PK parameter: total antibody of SHR-A2009
Measured: through study completion, an average of 2 years
PK parameter: free toxin of SHR-A2009
Measured: through study completion, an average of 2 years
Plasma concentration of Adebrelimab
Measured: through study completion, an average of 2 years
Immunogenicity of SHR-A2009 and Adebrelimab (Anti-SHR-A2009 antibody, anti- Adebrelimab antibody ) (Phase IB)
Measured: through study completion, an average of 2 years
Duration of response(DoR )
Measured: One year after the last subject was enrolled in the group
Progression Free Survival(PFS)
Measured: 2 years after the last subject was enrolled in the group
Objective response rate
Measured: 2 years after the last subject was enrolled in the group
overall survival (OS) (phase IB)
Measured: 3 years after the last subject was enrolled in the group
Incidence of AEs（Phase II (efficacy expansion phase)）
Measured: from Day1 to 90 days after last dose
Incidence of SAEs（Phase II (efficacy expansion phase)）
Measured: from Day1 to 90 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study startOct 2023 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Suzhou Suncadia Biopharmaceuticals Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06092268
- Sponsor's protocol ID
- SHR-A2009-201
- Status last verified
- Oct 2023
- First submitted
- 8 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IB/II, Open-Label, Multicentre Clinical Study to Evaluate the Safety, Tolerability and Efficacy of SHR-A2009 for Injection in Combination With Other Therapies in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06092268
- Acronym / sponsor ID
- SHR-A2009-201
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2023 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Part A: SHR-A2009 for injection in combination with Almonertinib Mesilate Tablets | Experimental | Drug: SHR-A2009 for injection ； Almonertinib Mesilate Tablets |
| Treatment Part B: SHR-A2009 for injection in combination with Adebrelimab Injection | Experimental | Drug: SHR-A2009 for injection；Adebrelimab Injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 to 75 years old (inclusive), Female or male
- Subjects with unresectable locally advanced or metastatic non-small cell lung cancer confirmed by histology or cytology
- Previously treated by EGFR-TKI or other standard treatment or have not been treated for metastatic setting;
- 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)
- ECOG performance score of 0-1;
Key exclusion criteria (19 listed)
- Subjects with active central nervous system (CNS) metastases.
- Spinal cord compression not cured by surgery and/or radiotherapy cannot be enrolled.
- Subjects with uncontrolled tumor-related pain
- Clinically uncontrollable third space fluid
- Received antitumor therapy such as chemotherapy within 4 weeks prior to the first dose of study drug;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-A2009 for injection ； Almonertinib Mesilate TabletsPhase 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. | Drug | Treatment Part A: SHR-A2009 for injection in combination with Almonertinib Mesilate Tablets |
| SHR-A2009 for injection；Adebrelimab InjectionPhase 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. | Drug | Treatment Part B: SHR-A2009 for injection in combination with Adebrelimab Injection |
Primary outcome
Incidence of dose-limiting toxicity (DLT) (phase IB)
Time frame: 21 days after the first dose was administered to each subject.
Objective Response Rate (ORR) (phase II).
Time frame: 2 years
11 secondary outcomes
PK parameter: toxin-binding antibody of SHR-A2009
Time frame: through study completion, an average of 2 years
PK parameter: total antibody of SHR-A2009
Time frame: through study completion, an average of 2 years
PK parameter: free toxin of SHR-A2009
Time frame: through study completion, an average of 2 years
Plasma concentration of Adebrelimab
Time frame: through study completion, an average of 2 years
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
Duration of response(DoR )
Time frame: One year after the last subject was enrolled in the group
Progression Free Survival(PFS)
Time frame: 2 years after the last subject was enrolled in the group
Objective response rate
Time frame: 2 years after the last subject was enrolled in the group
overall survival (OS) (phase IB)
Time frame: 3 years after the last subject was enrolled in the group
Incidence of AEs（Phase II (efficacy expansion phase)）
Time frame: from Day1 to 90 days after last dose
Incidence of SAEs（Phase II (efficacy expansion phase)）
Time frame: from Day1 to 90 days after last dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SHR-A2009 for injection ； Almonertinib Mesilate Tablets and SHR-A2009 for injection；Adebrelimab Injection in people with Advanced Solid Tumors, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fei Qiu (0518-82342973, fei.qiu@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicity (DLT) (phase IB) (time frame: 21 days after the first dose was administered to each subject.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.