Advanced Solid TumorsPhase 2NCT05349409
A Trial of the Combination of SHR-A1811 and Fluzoparib in HER2-Expressing Cancers
A Phase 2 study testing SHR-A1811 and Fluzoparib Capsule in people with Advanced Solid Tumors, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 2 sites in China.
Trial summary
The study is being conducted to evaluate safety, tolerability and preliminary efficacy of SHR-A1811 for Injection in combination with Fluzoparib Capsule for HER2-expressing advanced solid tumors of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- SHR-A1811 and Fluzoparib Capsule
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 2 sitesChina
- Study dates
- 9 Jun 2022to 31 May 2025
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged ≥18 years at the time of signing the ICF.
- At least one measurable lesion that meets RECIST 1.1 criteria in case of solid tumors.
- An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
- Life expectancy ≥12 weeks.
- Adequate organ functions as defined.
- Swallow the drug pills normally.
Who cannot join
- patients with active meningeal metastasis, or brain metastasis without surgical treatment or radiotherapy.
- Cancerous ascites and pleural effusion with clinical symptoms, which need puncture and drainage.
- Prior malignancy (other than current malignant tumor) within 5 years before the first dose of study treatment.
- History of autoimmune diseases.
- Not well controllable and serve cardiovascular disease.
- Prior lung disease with clinical significance.
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- Occurrence of ≥ grade 2 of bleeding event within 4 weeks before the first dose, or currently receiving the anticoagulation.
- Active Hepatitis B and Hepatitis C; or serve infection with medication control.
- The grade of toxicity from the prior anti-cancer therapy not decrease to ≤ 1.
- Occurrence of intestinal obstruction and gastrointestinal perforation within 3 months before the first dose.
Trial locations and contacts
2 sites in 1 country.
China2 sites
West China Hospital of Sichuan University
Chengdu, Sichuan, 410013
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
About this study
Official title: A Phase Ⅰb/Ⅱ Clinical Study on the Dosage Exploration and Efficiency Expansion of SHR-A1811 for Injection in Combination With Fluzoparib Capsule in HER2-Expressing Advanced Solid Tumors of Patients
The study is being conducted to evaluate safety, tolerability and preliminary efficacy of SHR-A1811 for Injection in combination with Fluzoparib Capsule for HER2-expressing advanced solid tumors of patients. To explore the reasonable dosage of dosage regimen of combination therapy for HER2-expressing advanced malignant tumors of patients.
- Conditions
- Advanced Solid Tumors
- Being tested
- SHR-A1811, Fluzoparib Capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1811Drug
SHR-A1811 for Injection: Given IV.
Fluzoparib CapsuleDrug
Also called SHR-3162
Fluzoparib Capsule: Given PO.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | SHR-A1811, Fluzoparib Receives: Drug: SHR-A1811; Drug: Fluzoparib Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limited Toxicity
Dose Limited Toxicity of SHR-A1811 for Injection in combination with Fluzoparib Capsule in Dose Exploration Period
Measured: first dose of study medication up to 21 days
Recommended phase II dose
The Recommended phase II dose of SHR-A1811 for Injection in combination with Fluzoparib Capsule in Dose Exploration Period
Measured: first dose of study medication up to 21 days
ORR
Objective Response Rate, Efficacy endpoints of SHR-A1811 for Injection in combination with Fluzoparib Capsule in HER2-Expressing Advanced Solid Tumors of Patients in indication expansion period
Measured: from the date of the first dose to the date of disease progression evaluated based on RECIST v1.1 criteria, or initiation of other anti-tumor treatment, whichever occurs first, up to 6 months
Secondary outcomes (15)
DoR
Duration of response, Efficacy endpoints of SHR-A1811 for Injection in combination with Fluzoparib Capsule in HER2-Expressing Advanced Solid Tumors of Patients
Measured: from the date of the firstly documented tumor response (evaluated based on RECIST v1.1 criteria) to the date of the firstly documented disease progression (evaluated based on RECIST v1.1 criteria) or the date of death for any reason, up to 6 months
DCR
Disease control rate, Efficacy endpoints of SHR-A1811 for Injection in combination with Fluzoparib Capsule in HER2-Expressing Advanced Solid Tumors of Patients
Measured: from the date of the first dose to the date of the firstly documented disease progression (evaluated based on RECIST v1.1 criteria) or the date of death for any reason, up to 6 months
TTR
Time to Recovery, Efficacy endpoints of SHR-A1811 for Injection in combination with Fluzoparib Capsule in HER2-Expressing Advanced Solid Tumors of Patients
Measured: from the date of the first dose to the date of treatment termination, up to 6 months
PFS
Progression-free survival, Efficacy endpoints of SHR-A1811 for Injection in combination with Fluzoparib Capsule in HER2-Expressing Advanced Solid Tumors of Patients
Measured: from the date of the first dose to the date of the firstly documented disease progression (evaluated based on RECIST v1.1 criteria) or the date of death for any reason, up to 6 months
OS
Overall survival, Efficacy endpoints of SHR-A1811 for Injection in combination with Fluzoparib Capsule in HER2-Expressing Advanced Solid Tumors of Patients
Measured: from the date of the first dose to the date of death for any reason, up to 100 months
12 months' survival rate
Efficacy endpoints of SHR-A1811 for Injection in combination with Fluzoparib Capsule in HER2-Expressing Advanced Solid Tumors of Patients
Measured: from the date of the first dose up to 12 months
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: from signature completion of ICF to 30 days after the last dose or to the beginning of the new anti-cancer therapy, up to 6 months
The occurrence rate of dose titration due to AE related with study medication
The occurrence rate of dose interruption, dose decrease and dose termination because of study drug related toxicity during the study
Measured: from signature completion of ICF to 30 days after the last dose or to the beginning of the new anti-cancer therapy, up to 6 months
Cmin
PK concentration of Fluzoparib Capsule
Measured: 10 min before first dose of Fluzoparib Capsule in C1D8 to 10 min before first dose of Fluzoparib Capsule in C8D1
C3h
PK concentration of Fluzoparib Capsule
Measured: 3 hour after first dose of Fluzoparib Capsule in C2D1
AUC0-t
PK parameters of SHR-A1811 for Injection
Measured: the date of first dose to 30 days after last dose
Cmin
PK parameters of SHR-A1811 for Injection
Measured: the date of first dose to 30 days after last dose
Cmax
PK parameters of SHR-A1811 for Injection
Measured: the date of first dose to 30 days after last dose
ADA
Anti-drug antibody, Immunogenicity of SHR-A1811 for Injection
Measured: the date of first dose up to 90 days after last dose
NAb
Neutralizing Antibody, Immunogenicity of SHR-A1811 for Injection
Measured: the date of first dose up 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 posted27 Apr 2022
- Study start9 Jun 2022
- Primary completion30 Nov 2024 (estimated)
- Study completion31 May 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- SHR-A1811 for Injection in combination with Fluzoparib Capsule.
- Masking
- None (open label)
- Enrolment
- 212 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
- NCT05349409
- Sponsor's protocol ID
- SHR-A1811-Ⅱ-201
- Status last verified
- Jun 2022
- First submitted
- 21 Apr 2022
- Last updated
- 30 Jun 2022
- 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 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅰb/Ⅱ Clinical Study on the Dosage Exploration and Efficiency Expansion of SHR-A1811 for Injection in Combination With Fluzoparib Capsule in HER2-Expressing Advanced Solid Tumors of Patients
- ClinicalTrials.gov ID
- NCT05349409
- Acronym / sponsor ID
- SHR-A1811-Ⅱ-201
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Jun 2022 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 27 Apr 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.
The study is being conducted to evaluate safety, tolerability and preliminary efficacy of SHR-A1811 for Injection in combination with Fluzoparib Capsule for HER2-expressing advanced solid tumors of patients. To explore the reasonable dosage of dosage regimen of combination therapy for HER2-expressing advanced malignant tumors of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- SHR-A1811 for Injection in combination with Fluzoparib Capsule.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: SHR-A1811, Drug: Fluzoparib CapsuleSHR-A1811, Fluzoparib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female aged ≥18 years at the time of signing the ICF.
- At least one measurable lesion that meets RECIST 1.1 criteria in case of solid tumors.
- An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
- Life expectancy ≥12 weeks.
- Adequate organ functions as defined.
Key exclusion criteria (10 listed)
- patients with active meningeal metastasis, or brain metastasis without surgical treatment or radiotherapy.
- Cancerous ascites and pleural effusion with clinical symptoms, which need puncture and drainage.
- Prior malignancy (other than current malignant tumor) within 5 years before the first dose of study treatment.
- History of autoimmune diseases.
- Not well controllable and serve cardiovascular disease.
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-A1811SHR-A1811 for Injection: Given IV. | Drug | Treatment group |
| Fluzoparib CapsuleAlso: SHR-3162Fluzoparib Capsule: Given PO. | Drug | Treatment group |
Primary outcome
Dose Limited Toxicity
Time frame: first dose of study medication up to 21 days
Dose Limited Toxicity of SHR-A1811 for Injection in combination with Fluzoparib Capsule in Dose Exploration Period
Recommended phase II dose
Time frame: first dose of study medication up to 21 days
The Recommended phase II dose of SHR-A1811 for Injection in combination with Fluzoparib Capsule in Dose Exploration Period
ORR
Time frame: from the date of the first dose to the date of disease progression evaluated based on RECIST v1.1 criteria, or initiation of other anti-tumor treatment, whichever occurs first, up to 6 months
Objective Response Rate, Efficacy endpoints of SHR-A1811 for Injection in combination with Fluzoparib Capsule in HER2-Expressing Advanced Solid Tumors of Patients in indication expansion period
15 secondary outcomes
DoR
Time frame: from the date of the firstly documented tumor response (evaluated based on RECIST v1.1 criteria) to the date of the firstly documented disease progression (evaluated based on RECIST v1.1 criteria) or the date of death for any reason, up to 6 months
DCR
Time frame: from the date of the first dose to the date of the firstly documented disease progression (evaluated based on RECIST v1.1 criteria) or the date of death for any reason, up to 6 months
TTR
Time frame: from the date of the first dose to the date of treatment termination, up to 6 months
PFS
Time frame: from the date of the first dose to the date of the firstly documented disease progression (evaluated based on RECIST v1.1 criteria) or the date of death for any reason, up to 6 months
OS
Time frame: from the date of the first dose to the date of death for any reason, up to 100 months
12 months' survival rate
Time frame: from the date of the first dose up to 12 months
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)
Time frame: from signature completion of ICF to 30 days after the last dose or to the beginning of the new anti-cancer therapy, up to 6 months
The occurrence rate of dose titration due to AE related with study medication
Time frame: from signature completion of ICF to 30 days after the last dose or to the beginning of the new anti-cancer therapy, up to 6 months
Cmin
Time frame: 10 min before first dose of Fluzoparib Capsule in C1D8 to 10 min before first dose of Fluzoparib Capsule in C8D1
C3h
Time frame: 3 hour after first dose of Fluzoparib Capsule in C2D1
AUC0-t
Time frame: the date of first dose to 30 days after last dose
Cmin
Time frame: the date of first dose to 30 days after last dose
Cmax
Time frame: the date of first dose to 30 days after last dose
ADA
Time frame: the date of first dose up to 90 days after last dose
NAb
Time frame: the date of first dose up 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 30 Jun 2022.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-A1811 and Fluzoparib Capsule in people with Advanced Solid Tumors, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 2 sites 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 10 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 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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?
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?
Dose Limited Toxicity (time frame: first dose of study medication up to 21 days). 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 30 Jun 2022.