Advanced Solid TumorPhase 1NCT05394818
The Clinical Study of SHR-A2009 for Injection in Patients With Advanced Solid Tumors
A Phase 1 study testing SHR-A2009 in people with Advanced Solid Tumor, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
This study is an open-label, phase I clinical trial of SHR-A2009 in patients with advanced solid tumors. The whole study is divided into three stages: dose escalation, dose expansion and efficacy expansion. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- SHR-A2009
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteChina
- Study dates
- 21 Jul 2022to 30 Apr 2024
- Phase
- Phase 1
- 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
- Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment, or standard treatment is not applicable currently;
- Have at least one measurable tumor lesion per RECIST v1.1;
- ECOG performance status of 0-1;
- Life expectancy ≥ 12 weeks;
- Adequate bone marrow and organ function.
- Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
Who cannot join
- Patients with active central nervous system metastases or meningeal metastases;
- Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug;
- Prior treatment with antibody-drug conjugate (ADC) consisting of topoisomerase I inhibitors;
- History of serious cardiovascular and cerebrovascular diseases;
- Severe infection within 4 weeks prior to the first dose;
- Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.
Trial locations and contacts
1 site in 1 country.
China1 site
Chinese PLA General Hospital-Department of Medical Oncology
Beijing, Beijing Municipality, 100039
About this study
Official title: An Open-label, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-A2009 for Injection in Patients With Advanced Solid Tumors
This study is an open-label, phase I clinical trial of SHR-A2009 in patients with advanced solid tumors. The whole study is divided into three stages: dose escalation, dose expansion and efficacy expansion.
- Conditions
- Advanced Solid Tumor
- Being tested
- SHR-A2009
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A2009Drug
The total dosage of SHR-A2009 was calculated according to the weight weighing results of the subjects before each administration, and was administered by intravenous drip.
| Study group | Role | What they receive |
|---|---|---|
| SHR-A2009 | Experimental | Not described Receives: Drug: SHR-A2009 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) or maximum administered dose (MAD)
Incidence and category of dose limiting toxicities (DLTs) during the first cycle of SHR-A2009 treatment.
Measured: From Day 1 to 90 days after last dose
Recommended Phase 2 dose (RP2D)
RP2D will be determined on the basis of evaluation on MTD/MAD, PK, efficacy data in dose escalation and dose expansion stages.
Measured: From Day 1 to 90 days after last dose
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) ([CTCAE] v5.0)
Assess safety and tolerability of SHR-A2009 by way of adverse events (CTCAE v5.0).
Measured: From Day 1 to 90 days after last dose
Secondary outcomes (9)
PK parameter: Tmax of SHR-A2009
Time to maximum concentration of SHR-A2009
Measured: approximately 6 months
PK parameter: Cmax of SHR-A2009
Maximum concentration of SHR-A2009
Measured: approximately 6 months
PK parameter: AUC0-t of SHR-A2009
area under the concentration-time curve from time 0 to the last measurable concentration time point of SHR-A2009
Measured: approximately 6 months
PK parameter: AUC0-∞ of SHR-A2009
area under the concentration-time curve from time 0 to infinity of SHR-A2009
Measured: approximately 6 months
Immunogenicity of SHR-A2009
Anti-SHR-A2009 antibody (ADA)
Measured: approximately 9 months
Overall response rate (ORR)
Evaluated using RECIST 1.1
Measured: approximately within 36 months
Duration of response (DoR)
Evaluated using RECIST 1.1
Measured: approximately within 36 months
Disease control rate (DCR)
Evaluated using RECIST 1.1
Measured: approximately within 36 months
Progression-free survival (PFS)
Evaluated using RECIST 1.1
Measured: approximately within 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start21 Jul 2022
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
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
- NCT05394818
- Sponsor's protocol ID
- SHR-A2009-I-102
- Status last verified
- Dec 2024
- First submitted
- 24 May 2022
- Last updated
- 27 Dec 2024
- 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 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-A2009 for Injection in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05394818
- Acronym / sponsor ID
- SHR-A2009-I-102
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Jul 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 27 May 2022 (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, phase I clinical trial of SHR-A2009 in patients with advanced solid tumors. The whole study is divided into three stages: dose escalation, dose expansion and efficacy expansion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| SHR-A2009 | Experimental | Drug: SHR-A2009 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment, or standard treatment is not applicable currently;
- Have at least one measurable tumor lesion per RECIST v1.1;
- ECOG performance status of 0-1;
- Life expectancy ≥ 12 weeks;
- Adequate bone marrow and organ function.
Key exclusion criteria (6 listed)
- Patients with active central nervous system metastases or meningeal metastases;
- Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug;
- Prior treatment with antibody-drug conjugate (ADC) consisting of topoisomerase I inhibitors;
- History of serious cardiovascular and cerebrovascular diseases;
- Severe infection within 4 weeks prior to the first dose;
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-A2009The total dosage of SHR-A2009 was calculated according to the weight weighing results of the subjects before each administration, and was administered by intravenous drip. | Drug | SHR-A2009 |
Primary outcome
Maximum tolerated dose (MTD) or maximum administered dose (MAD)
Time frame: From Day 1 to 90 days after last dose
Incidence and category of dose limiting toxicities (DLTs) during the first cycle of SHR-A2009 treatment.
Recommended Phase 2 dose (RP2D)
Time frame: From Day 1 to 90 days after last dose
RP2D will be determined on the basis of evaluation on MTD/MAD, PK, efficacy data in dose escalation and dose expansion stages.
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) ([CTCAE] v5.0)
Time frame: From Day 1 to 90 days after last dose
Assess safety and tolerability of SHR-A2009 by way of adverse events (CTCAE v5.0).
9 secondary outcomes
PK parameter: Tmax of SHR-A2009
Time frame: approximately 6 months
PK parameter: Cmax of SHR-A2009
Time frame: approximately 6 months
PK parameter: AUC0-t of SHR-A2009
Time frame: approximately 6 months
PK parameter: AUC0-∞ of SHR-A2009
Time frame: approximately 6 months
Immunogenicity of SHR-A2009
Time frame: approximately 9 months
Overall response rate (ORR)
Time frame: approximately within 36 months
Duration of response (DoR)
Time frame: approximately within 36 months
Disease control rate (DCR)
Time frame: approximately within 36 months
Progression-free survival (PFS)
Time frame: approximately within 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR-A2009 in people with Advanced Solid Tumor, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) or maximum administered dose (MAD) (time frame: From Day 1 to 90 days after last dose). The study lists 3 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 27 Dec 2024.