Advanced Malignant TumorsPhase 1NCT05198817
A Trial of SHR-2002 Injection or Combined With Other Anti-cancer Medication in Advanced Malignant Tumors of Patients
A Phase 1 study testing SHR-2002 injection、Camrelizumab for Injection, SHR-1316 injection, SHR-1701 injection in people with Advanced Malignant Tumors, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 5 sites in China.
Trial summary
The study is being conducted to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of SHR-2002 injection monotherapy and in combination with other anti-cancer therapy for advanced malignant tumors of patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Malignant Tumors
- What is being tested?
- SHR-2002 injection、Camrelizumab for Injection, SHR-1316 injection, SHR-1701 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 5 sitesChina
- Study dates
- 22 Feb 2022to 30 Jun 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;
- Male or female aged ≥18 years and ≤70 years at the time of signing the ICF;
- Histopathologically or cytologically documented advanced or metastatic malignancies;
- An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
- Life expectancy ≥12 weeks;
- Adequate organ functions as defined;
- Female and male patients of reproductive potential must agree to use highly effective contraception during the study treatment period and within 6 months after the last investigational drug administration; Female of childbearing potential must have a negative serum human chorionic gonadotropin (HCG) test within 7 days before the first dose of the investigational drugs and must not be breastfeeding.
Who cannot join
- Patients with known active central nervous system (CNS) metastases and/or carcinomatous meningitis;
- Patients with active brain metastasis (without medical control or with clinical symptoms), cancerous meningitis, spinal cord compression, or patients with a history of primary tumors of the central nervous system ;
- Patients with tumor-related pain that cannot be controlled as determined by the investigator;
- Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion;
- Systemic anti-tumor therapy within 28 days prior to the first dose of the study treatment;
- Surgical procedures requiring general anesthesia within 28 days prior to the first dose of the study treatment;
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- Patients who have received >30 Gy of radical radiotherapy within 28 days before the first dose of study treatment;
- Unresolved CTCAE Grade >1 toxicity attributed to any prior anti-tumor therapy;
- Use of live attenuated vaccines within 28 days before the first dose of the study treatment;
- Patients who have received any systemic immunosuppressants within 14 days prior to the first dose of study treatment;
- Patients with interstitial pneumonitis or interstitial lung disease; past history of interstitial pneumonitis or interstitial lung disease requiring hormone therapy;
- History of autoimmune diseases;
- History of clinically significant bleeding symptom or bleeding tendency within 3 months before the first dose of study treatment;
- History of clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to the first dose of study treatment;
- Evidence or history of arterial/venous thrombosis within 3 months before the first dose;
- Prior malignancy (other than current malignant tumor) within 5 ears before the first dose of study treatment;
- Known history of serious allergic reactions to the investigational product or its main ingredients;
- History of immunodeficiency;
- Presence of active hepatitis B or active hepatitis C;
- Severe infections within 4 weeks prior to the first study treatment;
- Evidence or history of active pulmonary tuberculosis within 1 year before study entry;
- any other conditions that are not suitable for participation in the study in the investigator's opinion.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Hunan Cancer Hospital
Changsha, Hunan, 410006
West China Hospital of Sichuan University
Chengdu, Sichuan, 410013
Linyi Cancer Hospital
Linyi, Shandong, 276002
Henan Science and Technology University First Affiliated Hospital
Luoyang, Henan, 471003
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
About this study
Official title: A Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SHR-2002 Injection or in Combination With Other Anti-cancer Therapy in Advanced Malignant Tumors of Patients
The study is being conducted to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of SHR-2002 injection monotherapy and in combination with other anti-cancer therapy for advanced malignant tumors of patients. To explore the reasonable dosage of SHR-2002 injection monotherapy and dosage regimen of combination therapy for advanced malignant tumors of patients.
- Conditions
- Advanced Malignant Tumors
- Being tested
- SHR-2002 injection、Camrelizumab for Injection, SHR-1316 injection, SHR-1701 injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-2002 injection、Camrelizumab for Injection, SHR-1316 injection, SHR-1701 injectionDrug
Firstly Dose Escalation and Dose Expansion of SHR-2002 injection monotherapy should be conducted. After RP2D and MTD of the SHR-2002 injection monotherapy were confirmed, Dose Escalation, Dose Expansion and Efficacy Expansion of SHR-2002 injection in combination with other anti-cancer treatment would be completed, including Camrelizumab for Injection, or SHR-1316 injection, or SHR-1701 injection.
| Study group | Role | What they receive |
|---|---|---|
| Single Group | Experimental | Not described Receives: Drug: SHR-2002 injection、Camrelizumab for Injection, SHR-1316 injection, SHR-1701 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
The Maximum tolerated dose of SHR-2002 injection monotherapy or in combination with Camrelizumab for Injection, or SHR-1316 injection, or SHR-1701 injection
Measured: first dose of study medication up to 21 days
Recommended phase II dose
The Recommended phase II dose of SHR-2002 injection monotherapy or in combination with Camrelizumab for Injection, or SHR-1316 injection, or SHR-1701 injection
Measured: first dose of study medication up to 21 days
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 90 days after the last dose or to the beginning of the new anti-cancer therapy, whichever came first, assessed up to 24 weeks
Secondary outcomes (21)
Tmax
PK parameters of single dose of SHR-2002 injection monotherapy
Measured: 0.5 hour before first dose to the 336 hours after first dose
Cmax
PK parameters of single dose of SHR-2002 injection monotherapy
Measured: 0.5 hour before first dose to the 336 hours after first dose
AUC0-t
PK parameters of single dose of SHR-2002 injection monotherapy
Measured: 0.5 hour before first dose to the 336 hours after first dose
AUC0-∞
PK parameters of single dose of SHR-2002 injection monotherapy
Measured: 0.5 hour before first dose to the 336 hours after first dose
t1/2
PK parameters of single dose of SHR-2002 injection monotherapy
Measured: 0.5 hour before first dose to the 336 hours after first dose
CL
PK parameters of single dose of SHR-2002 injection monotherapy
Measured: 0.5 hour before first dose to the 336 hours after first dose
Vss
PK parameters of single dose of SHR-2002 injection monotherapy
Measured: 0.5 hour before first dose to the 336 hours after first dose
Cmax, ss
PK parameters of multiple doses of SHR-2002 monotherapy
Measured: 0.5 hour before second dose to the 30 days after last dose
Ctrough, ss
PK parameters of multiple doses of SHR-2002 monotherapy
Measured: 0.5 hour before second dose to the 30 days after last dose
Rac
PK parameters of multiple doses of SHR-2002 monotherapy
Measured: 0.5 hour before second dose to the 30 days after last dose
RO
Receptor occupancy, PD indicators of SHR-2002 injection monotherapy
Measured: 0.5 hour before second dose to the 30 days after last dose
Cytokine concentration
PD indicators of SHR-2002 injection monotherapy
Measured: 0.5 hour before second dose to the 30 days after last dose
Ctrough, ss
PK parameters of SHR -2002, Camrelizumab for Injection, SHR-1316 injection and SHR-1701 injection during combination therapy period
Measured: 0.5 hour before second dose to the 90 days after last dose
Rac
PK parameters of SHR -2002, Camrelizumab for Injection, SHR-1316 injection and SHR-1701 injection during combination therapy period
Measured: 0.5 hour before second dose to the 90 days after last dose
ADA
Anti-drug antibody, Immunogenicity of SHR-2002 in monotherapy and combination therapy, Camrelizumab for Injection, SHR-1316 injection and SHR-1701 injection
Measured: 0.5 hour before second dose to the 90 days after last dose
NAb
Immunogenicity of Camrelizumab for Injection, SHR-1316 injection and SHR-1701 injection
Measured: 0.5 hour before second dose to the 90 days after last dose
ORR
Objective Response Rate, Efficacy endpoints of SHR-2002 injection monotherapy or in combination with Camrelizumab for Injection, or SHR-1316 injection, or SHR-1701 injection in treatment of patients with Advanced Malignant Tumors
Measured: from the date of the first dose to the date of disease progression evaluated based on RECIST v1.1 criteria, death, lost to follow-up, voluntary withdrawal, or initiation of other anti-tumor treatment, whichever occurs first, assessed up to 6 months]
DoR
Duration of response, Efficacy endpoints of SHR-2002 injection monotherapy or in combination with Camrelizumab for Injection, or SHR-1316 injection, or SHR-1701 injection in treatment of patients with Advanced Malignant Tumors
Measured: from the date of the firstly documented tumor response to the date of the firstly documented disease progression or the date of death for any reason, assessed up to 6 months
DCR
Disease control rate, Efficacy endpoints of SHR-2002 injection monotherapy or in combination with Camrelizumab for Injection, or SHR-1316 injection, or SHR-1701 injection in treatment of patients with Advanced Malignant Tumors
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, assessed up to 6 months
PFS
Progression-free survival, Efficacy endpoints of SHR-2002 injection monotherapy or in combination with Camrelizumab for Injection, or SHR-1316 injection, or SHR-1701 injection in treatment of patients with Advanced Malignant Tumors
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, assessed up to 6 months
OS
Overall survival, Efficacy endpoints of SHR-2002 injection monotherapy or in combination with Camrelizumab for Injection, or SHR-1316 injection, or SHR-1701 injection in treatment of patients with Advanced Malignant Tumors
Measured: from the date of the first dose to the date of death for any reason，assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start22 Feb 2022
- Primary completion31 Jan 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- SHR-2002 injection monotherapy and in combination with other anti-cancer therapy
- Masking
- None (open label)
- Enrolment
- 240 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
- NCT05198817
- Sponsor's protocol ID
- SHR-2002-I-101
- Status last verified
- Jun 2022
- First submitted
- 3 Jan 2022
- Last updated
- 28 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 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SHR-2002 Injection or in Combination With Other Anti-cancer Therapy in Advanced Malignant Tumors of Patients
- ClinicalTrials.gov ID
- NCT05198817
- Acronym / sponsor ID
- SHR-2002-I-101
- Conditions
- Advanced Malignant Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 20 Jan 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, pharmacokinetics and preliminary efficacy of SHR-2002 injection monotherapy and in combination with other anti-cancer therapy for advanced malignant tumors of patients. To explore the reasonable dosage of SHR-2002 injection monotherapy and dosage regimen of combination therapy for 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-2002 injection monotherapy and in combination with other anti-cancer therapy
| Arm | Type | Receives |
|---|---|---|
| Single Group | Experimental | Drug: SHR-2002 injection、Camrelizumab for Injection, SHR-1316 injection, SHR-1701 injection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;
- Male or female aged ≥18 years and ≤70 years at the time of signing the ICF;
- Histopathologically or cytologically documented advanced or metastatic malignancies;
- An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
- Life expectancy ≥12 weeks;
Key exclusion criteria (22 listed)
- Patients with known active central nervous system (CNS) metastases and/or carcinomatous meningitis;
- Patients with active brain metastasis (without medical control or with clinical symptoms), cancerous meningitis, spinal cord compression, or patients with a history of primary tumors of the central nervous system ;
- Patients with tumor-related pain that cannot be controlled as determined by the investigator;
- Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion;
- Systemic anti-tumor therapy within 28 days prior to the first dose of the study treatment;
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-2002 injection、Camrelizumab for Injection, SHR-1316 injection, SHR-1701 injectionFirstly Dose Escalation and Dose Expansion of SHR-2002 injection monotherapy should be conducted. After RP2D and MTD of the SHR-2002 injection monotherapy were confirmed, Dose Escalation, Dose Expansion and Efficacy Expansion of SHR-2002 injection in combination with other anti-cancer treatment would be completed, including Camrelizumab for Injection, or SHR-1316 injection, or SHR-1701 injection. | Drug | Single Group |
Primary outcome
Maximum tolerated dose
Time frame: first dose of study medication up to 21 days
The Maximum tolerated dose of SHR-2002 injection monotherapy or in combination with Camrelizumab for Injection, or SHR-1316 injection, or SHR-1701 injection
Recommended phase II dose
Time frame: first dose of study medication up to 21 days
The Recommended phase II dose of SHR-2002 injection monotherapy or in combination with Camrelizumab for Injection, or SHR-1316 injection, or SHR-1701 injection
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)
Time frame: from signature completion of ICF to 90 days after the last dose or to the beginning of the new anti-cancer therapy, whichever came first, assessed up to 24 weeks
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
21 secondary outcomes
Tmax
Time frame: 0.5 hour before first dose to the 336 hours after first dose
Cmax
Time frame: 0.5 hour before first dose to the 336 hours after first dose
AUC0-t
Time frame: 0.5 hour before first dose to the 336 hours after first dose
AUC0-∞
Time frame: 0.5 hour before first dose to the 336 hours after first dose
t1/2
Time frame: 0.5 hour before first dose to the 336 hours after first dose
CL
Time frame: 0.5 hour before first dose to the 336 hours after first dose
Vss
Time frame: 0.5 hour before first dose to the 336 hours after first dose
Cmax, ss
Time frame: 0.5 hour before second dose to the 30 days after last dose
Ctrough, ss
Time frame: 0.5 hour before second dose to the 30 days after last dose
Rac
Time frame: 0.5 hour before second dose to the 30 days after last dose
RO
Time frame: 0.5 hour before second dose to the 30 days after last dose
Cytokine concentration
Time frame: 0.5 hour before second dose to the 30 days after last dose
Ctrough, ss
Time frame: 0.5 hour before second dose to the 90 days after last dose
Rac
Time frame: 0.5 hour before second dose to the 90 days after last dose
ADA
Time frame: 0.5 hour before second dose to the 90 days after last dose
NAb
Time frame: 0.5 hour before second dose to the 90 days after last dose
ORR
Time frame: from the date of the first dose to the date of disease progression evaluated based on RECIST v1.1 criteria, death, lost to follow-up, voluntary withdrawal, or initiation of other anti-tumor treatment, whichever occurs first, assessed up to 6 months]
DoR
Time frame: from the date of the firstly documented tumor response to the date of the firstly documented disease progression or the date of death for any reason, assessed 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, assessed 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, assessed up to 6 months
OS
Time frame: from the date of the first dose to the date of death for any reason，assessed up to 100 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 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.
5 sites 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-2002 injection、Camrelizumab for Injection, SHR-1316 injection, SHR-1701 injection in people with Advanced Malignant Tumors, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 5 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 7 inclusion and 22 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 28 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 5 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 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?
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 (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 28 Jun 2022.