Advanced Solid TumorPhase 1NCT05819684
A Study of SHR-4602 in Subjects With Advanced Malignant Solid Tumors
A Phase 1 study testing SHR-4602 for injection in people with Advanced Solid Tumor, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
This is an open-label, three-part study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-4602 and preliminary anti-tumor efficacy in HER2 expressing or mutated advanced malignant solid tumor subjects. 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-4602 for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteChina
- Study dates
- 18 Apr 2023to 30 May 2026
- 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
- Advanced/unresectable or metastatic solid tumor with HER2 expression or mutation that is refractory to or intolerable with standard treatment, or for which no standard treatment is available;
- At least one measurable lesion based on RECIST v1.1 criteria;
- ECOG PS score: 0-1 points;
- Expected survival period ≥ 3 months;
- Adequate organ function;
- Must take one medically approved contraceptive measure;
- Patients voluntarily joined the study and signed informed consent.
Who cannot join
- Patients with known CNS metastasis or hepatic encephalopathy;
- Suffering from peripheral neuropathy;
- History of clinically significant lung diseases (e.g., interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or suspected to have these diseases by imaging at screening period;
- Patients with any active, known or suspected autoimmune disorder;
- With known severe allergic reactions to any other monoclonal antibodies;
- Patients with symptomatic ascites or pleural effusion requiring paracentesis and drainage, or patients who have undergone ascites or pleural effusion drainage within 2 weeks before the first dose;
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- Patients with other malignancies currently or within the past 5 years;
- Uncontrolled cardiac diseases or symptoms;
- With known hereditary or acquired bleeding (e.g., coagulopathy) or a tendency to clot (e.g., hemophiliacs);
- Patients with other potential factors that may affect the study results.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510120
Erwei Song, Doctor, songew@mail.sysu.edu.cn
Herui Yao, Doctor, yaoherui@163.com
About this study
Official title: A Phase I Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-4602 in HER2 Expressing or Mutated Advanced Malignant Solid Tumor Subjects
This is an open-label, three-part study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-4602 and preliminary anti-tumor efficacy in HER2 expressing or mutated advanced malignant solid tumor subjects.
- Conditions
- Advanced Solid Tumor
- Being tested
- SHR-4602 for injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-4602 for injectionDrug
be administered via intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose escalation | Experimental | Not described Receives: Drug: SHR-4602 for injection |
| Part 2: PK expansion | Experimental | Not described Receives: Drug: SHR-4602 for injection |
| Part 3: efficacy expansion | Experimental | Not described Receives: Drug: SHR-4602 for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs)
Measured: From Day 1 to 90 days after last dose
Maximum tolerated dose (MTD)
Measured: From Day 1 to 21 days after first dose
Dose Limiting Toxicities (DLT)
Measured: From Day 1 to 21 days after first dose
Recommended Phase 2 dose (RP2D)
Measured: From Day 1 to 90 days after last dose
Secondary outcomes (9)
PK parameters of SHR-4602 for Injection: Cmax
Measured: the date of first dose to 30 days after last dose
PK parameters of SHR-4602 for Injection: AUC0-t
Measured: the date of first dose to 30 days after last dose
PK parameters of SHR-4602 for Injection: Tmax
Measured: the date of first dose to 30 days after last dose
PK parameters of SHR-4602 for Injection: T1/2
Measured: the date of first dose to 30 days after last dose
ADA
Anti-drug antibody, Immunogenicity of SHR-4602 for Injection
Measured: the date of first dose up to 90 days after last dose
ORR
Objective Response Rate, Efficacy endpoints of SHR-4602 for Injection，As assessed by RECIST v1.1
Measured: the date of first dose up to 90 days after last dose
DCR
Disease control rate, Efficacy endpoints of SHR-4602 for Injection，As assessed by RECIST v1.1
Measured: the date of first dose up to 90 days after last dose
DOR
Duration of response, Efficacy endpoints of SHR-4602 for Injection，As assessed by RECIST v1.1
Measured: the date of first dose up to 90 days after last dose
PFS
Progression Free Survival, Efficacy endpoints of SHR-4602 for Injection，As assessed by RECIST v1.1
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 posted19 Apr 2023
- Study start18 Apr 2023
- Primary completion30 May 2025 (estimated)
- Study completion30 May 2026 (estimated)
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
- Non-randomised
- Intervention model
- Single group
- Model description
- This is an open-label, three-part study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-4602 and preliminary anti-tumor efficacy in HER2 expressing or mutated advanced malignant solid tumor subjects. Include three stages: dose escalation, PK expansion, and efficacy expansion.
- Masking
- None (open label)
- Enrolment
- 133 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
- NCT05819684
- Sponsor's protocol ID
- SHR-4602-I-101
- Status last verified
- Jun 2024
- First submitted
- 6 Apr 2023
- Last updated
- 21 Jun 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 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-4602 in HER2 Expressing or Mutated Advanced Malignant Solid Tumor Subjects
- ClinicalTrials.gov ID
- NCT05819684
- Acronym / sponsor ID
- SHR-4602-I-101
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 133 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Apr 2023 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 19 Apr 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 is an open-label, three-part study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-4602 and preliminary anti-tumor efficacy in HER2 expressing or mutated advanced malignant solid tumor subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is an open-label, three-part study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-4602 and preliminary anti-tumor efficacy in HER2 expressing or mutated advanced malignant solid tumor subjects. Include three stages: dose escalation, PK expansion, and efficacy expansion.
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose escalation | Experimental | Drug: SHR-4602 for injection |
| Part 2: PK expansion | Experimental | Drug: SHR-4602 for injection |
| Part 3: efficacy expansion | Experimental | Drug: SHR-4602 for injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Advanced/unresectable or metastatic solid tumor with HER2 expression or mutation that is refractory to or intolerable with standard treatment, or for which no standard treatment is available;
- At least one measurable lesion based on RECIST v1.1 criteria;
- ECOG PS score: 0-1 points;
- Expected survival period ≥ 3 months;
- Adequate organ function;
Key exclusion criteria (10 listed)
- Patients with known CNS metastasis or hepatic encephalopathy;
- Suffering from peripheral neuropathy;
- History of clinically significant lung diseases (e.g., interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or suspected to have these diseases by imaging at screening period;
- Patients with any active, known or suspected autoimmune disorder;
- With known severe allergic reactions to any other monoclonal antibodies;
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-4602 for injectionbe administered via intravenous (IV) infusion | Drug | Part 1: Dose escalation, Part 2: PK expansion, Part 3: efficacy expansion |
Primary outcome
Incidence and severity of adverse events (AEs)
Time frame: From Day 1 to 90 days after last dose
Maximum tolerated dose (MTD)
Time frame: From Day 1 to 21 days after first dose
Dose Limiting Toxicities (DLT)
Time frame: From Day 1 to 21 days after first dose
Recommended Phase 2 dose (RP2D)
Time frame: From Day 1 to 90 days after last dose
9 secondary outcomes
PK parameters of SHR-4602 for Injection: Cmax
Time frame: the date of first dose to 30 days after last dose
PK parameters of SHR-4602 for Injection: AUC0-t
Time frame: the date of first dose to 30 days after last dose
PK parameters of SHR-4602 for Injection: Tmax
Time frame: the date of first dose to 30 days after last dose
PK parameters of SHR-4602 for Injection: T1/2
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
ORR
Time frame: the date of first dose up to 90 days after last dose
DCR
Time frame: the date of first dose up to 90 days after last dose
DOR
Time frame: the date of first dose up to 90 days after last dose
PFS
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 21 Jun 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.
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-4602 for injection 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 7 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 21 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xin Shi (0518-82342973, xin.shi.xs3@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs) (time frame: From Day 1 to 90 days after last dose). The study lists 4 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 21 Jun 2024.