Advanced Solid TumorPhase 1NCT04947033
A Study Evaluating TJ210001 in the Treatment of Subjects With Advanced Solid Tumors
A Phase 1 study testing TJ210001 Injection in people with Advanced Solid Tumor, run by I-Mab Biopharma US Limited at 1 site in China.
Trial summary
A phase I clinical study evaluating TJ210001 in the treatment of subjects with advanced solid tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- TJ210001 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2023to 31 Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both male and female aged 18 or above;
- ECOG score: 0-1;
- The subjects voluntarily participate in the study, sign the Informed Consent Form, with good compliance, and can cooperate with the follow-up.
- Subjects with advanced malignant solid tumors confirmed by histology or cytology have failed the standard treatment or have no standard treatment protocol or are not suitable for standard treatment at this stage.
- Subjects should have at least one evaluable lesion as defined by RECIST V1.1;
- Subjects who have recovered from the toxicity of previous anti-tumor therapy (CTCAE v5.0) to ≤ Grade 1 or baseline (except for alopecia and neuropathy);
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- Expected survival period ≥ 3 months;
- The main organs are functioning normally and the laboratory indicators meet the following standards:
- Absolute neutrophil count (ANC) ≥ 1500/μL (≥1.5 ×109/L), and have not received growth factor or colony stimulating factor treatment within 7 days before the start of the study;
- Platelets ≥ 75,000/uL (≥100×109/L), and have not received platelet therapy within 14 days before the start of the study;
- Hemoglobin ≥8.5g/dL, and have not received blood transfusion treatment in the 14 days before the start of the study (have not received erythropoietin within 3 days before the start of the study);
- Adequate renal function and serum creatinine ≤ 1.5×ULN or creatinine clearance ≥ 45 mL/min (calculated by Cockcroft-Gault formula);
- Serum total bilirubin ≤ 1.5 × ULN; if diagnosed with Gilbert's disease, serum total bilirubin ≤ 3.0 × ULN; Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 3× ULN, or ≤5×ULN for subjects with liver metastasis;
- Activated partial thromboplastin time (aPTT) ≤1.5×ULN; International normalized ratio (INR) ≤1.5×ULN (except for anticoagulants with stable doses);
- QT interval for QTcF correction and/or QTcB correction of electrocardiogram: male ≤450 ms, female ≤470 ms;
- Echocardiography: Left ventricular ejection fraction (LVEF) ≥50%;
- Eligible patients (male and female) with fertility must agree to use reliable contraceptive methods (hormonal or barrier method or abstinence, etc.) with their partners during the study period and at least 90 days after the last administration; Female patients of childbearing age must have a negative blood or urine pregnancy test within 7 days before the first administration of the study drug.
Who cannot join
- Have received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks before the first administration of the study drug, except for the following items:
- Nitrosourea or Mitomycin C has been used within 6 weeks before the first administration of the study drug;
- Oral fluorouracil and small molecule targeted drugs are used 2 weeks before the first administration of the study drug or 5 half-lives of the drug (whichever is longer);
- Chinese medicine with anti-tumor indications is used within 2 weeks before the first administration of the study drug.
- Have received other unmarketed clinical study drugs or treatments within 4 weeks before the first administration of the study drug;
- Have received major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks before the first administration of the study drug, or the elective surgery will be required during the study period;
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- Have received systemic glucocorticoids (prednisone> 10 mg/day or equivalent doses of similar drugs) or other immunosuppressive agents within 14 days before the first administration of the study drug; Except for the following situations: Use topical, eye, intra-articular, intranasal and inhaled glucocorticoid therapy; short-term use of glucocorticoid for preventive treatment (such as prevention of contrast agent allergy)
- Have received immunomodulatory drugs, including but not limited to thymosin, interleukin-2, interferon, etc. within 14 days before the first administration of study drug;
- Have received the live attenuated vaccine within 4 weeks before the first administration of study drug;
- Have received C5aR inhibitor treatment in the past;
- Those who have previously received allogeneic hematopoietic stem cell transplantation or organ transplantation;
- The adverse reactions of previous anti-tumor treatments have not yet recovered to CTCAE 5.0 grade evaluation ≤ grade 1 (except for the toxicity that the investigator judges to have no safety risk, such as alopecia, grade 2 peripheral neurotoxicity, etc.);
- Patients with central nervous system metastasis or meningeal metastasis with clinical symptoms, or other evidence indicates that the patient's central nervous system metastasis or meningeal metastasis has not been controlled, and those who are judged by the investigators to be unsuitable for inclusion;
- Those who have an active infection 1 week before the first administration of the study drug and currently require systemic anti-infective treatment;
- Have a history of immunodeficiency, including HIV antibody test positive ;
- Active hepatitis B (HBsAg positive and HBV-DNA > the lower limit of detection of the study center). For subjects who are HBsAg positive but HBV-DNA negative, if the antiviral therapy is needed judged by investigator, the subjects will not be excluded; Hepatitis C virus infection (anti-HCV positive);
- Patients currently suffering from interstitial lung disease;
- Have a history of severe cardiovascular and cerebrovascular diseases, including but not limited to:
- Have severe heart rhythm or conduction abnormalities, such as ventricular arrhythmia that requires clinical intervention, grade Ⅱ-Ⅲ atrioventricular block;
- Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or above cardiovascular and cerebrovascular events occurred within 6 months before the first administration of study drug;
- Patients with the New York Heart Association (NYHA) heart function classification ≥ Grade II;
- Have clinically uncontrollable hypertension;
- Patients with active, or have had autoimmune diseases that may have recurrence (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis), except for patients with clinically stable autoimmune thyroid disease;
- Patients who have received immunotherapy and have irAE grade ≥ grade 3;
- Patients who have clinically uncontrollable fluid in the third space and who are judged by the investigator to be unsuitable for enrollment;
- Patients who are known to have alcohol or drug dependence;
- Patients with mental disorders or poor compliance;
- Pregnant or lactating women;
- The subjects who are considered by investigators to have a history of other serious systemic diseases or other reasons are not suitable to participate in this clinical study."
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality, 310000
Jin Li, 8613761222111, lijin@csco.org.cn
Jin Li
About this study
Official title: A Phase I Clinical Study Evaluating the Safety, Tolerability, MTD or MAD, PK, PD, and Antitumor Activity of TJ210001(a Fully Human C5aR Monoclonal Antibody) in Subjects With Advanced Solid Tumors
A phase I clinical study evaluating TJ210001 in the treatment of subjects with advanced solid tumors
Read the detailed description
This study is a phase I clinical study evaluating TJ210001 monotherapy in patients with advanced solid tumors in dose escalation. The overall design of the study is shown in the figure below. The purpose of the TJ210001 single-dose escalation study in subjects with advanced solid tumors is to evaluate the safety and tolerability of monotherapy to determine the MTD (or MAD) and clinically recommended doses of TJ210001 monotherapy.
- Conditions
- Advanced Solid Tumor
- Being tested
- TJ210001 Injection
- Keywords
- Advanced Solid Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TJ210001 InjectionDrug
The test drug TJ210001 will be preset with 5 escalation dose levels: 0.3mg/kg, 1mg/kg, 3mg/kg, 10mg/kg and 15mg/kg, administered once a week.
| Study group | Role | What they receive |
|---|---|---|
| TJ210001 Injection | Experimental | Single Arm Dose expansion Receives: Drug: TJ210001 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate and Severity of Dose-limiting toxicity （DLT）
Measured: up to 28 days after last dose of study drug
Maximum tolerated dose (MTD)
Measured: up to 21days following first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start31 Dec 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 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 TumorStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I-Mab Biopharma US Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jin Li, Principal investigator, Shanghai East Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947033
- Sponsor's protocol ID
- TJ210001STM102
- Status last verified
- Mar 2023
- First submitted
- 24 Jun 2021
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study Evaluating the Safety, Tolerability, MTD or MAD, PK, PD, and Antitumor Activity of TJ210001(a Fully Human C5aR Monoclonal Antibody) in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04947033
- Acronym / sponsor ID
- TJ210001STM102
- Conditions
- Advanced Solid Tumor
- Keywords
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- I-Mab Biopharma US LimitedIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Jul 2021 (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.
A phase I clinical study evaluating TJ210001 in the treatment of subjects with advanced solid tumors
Detailed description
This study is a phase I clinical study evaluating TJ210001 monotherapy in patients with advanced solid tumors in dose escalation. The overall design of the study is shown in the figure below. The purpose of the TJ210001 single-dose escalation study in subjects with advanced solid tumors is to evaluate the safety and tolerability of monotherapy to determine the MTD (or MAD) and clinically recommended doses of TJ210001 monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TJ210001 Injection | Experimental | Drug: TJ210001 InjectionSingle Arm Dose expansion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Both male and female aged 18 or above;
- ECOG score: 0-1;
- The subjects voluntarily participate in the study, sign the Informed Consent Form, with good compliance, and can cooperate with the follow-up.
- Subjects with advanced malignant solid tumors confirmed by histology or cytology have failed the standard treatment or have no standard treatment protocol or are not suitable for standard treatment at this stage.
- Subjects should have at least one evaluable lesion as defined by RECIST V1.1;
Key exclusion criteria (29 listed)
- Have received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks before the first administration of the study drug, except for the following items:
- Have received other unmarketed clinical study drugs or treatments within 4 weeks before the first administration of the study drug;
- Have received major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks before the first administration of the study drug, or the elective surgery will be required during the study period;
- Have received systemic glucocorticoids (prednisone> 10 mg/day or equivalent doses of similar drugs) or other immunosuppressive agents within 14 days before the first administration of the study drug; Except for the following situations: Use topical, eye, intra-articular, intranasal and inhaled glucocorticoid therapy; short-term use of glucocorticoid for preventive treatment (such as prevention of contrast agent allergy)
- Have received immunomodulatory drugs, including but not limited to thymosin, interleukin-2, interferon, etc. within 14 days before the first administration 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 |
|---|---|---|
| TJ210001 InjectionThe test drug TJ210001 will be preset with 5 escalation dose levels: 0.3mg/kg, 1mg/kg, 3mg/kg, 10mg/kg and 15mg/kg, administered once a week. | Drug | TJ210001 Injection |
Primary outcome
Rate and Severity of Dose-limiting toxicity （DLT）
Time frame: up to 28 days after last dose of study drug
Maximum tolerated dose (MTD)
Time frame: up to 21days following first dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Jin Li principal investigator
Shanghai East Hospital
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 TJ210001 Injection in people with Advanced Solid Tumor, run by I-Mab Biopharma US Limited 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 17 inclusion and 29 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 14 Mar 2023. 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 Lingling Gu (021-60575734, lingling.gu@i-mabbiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate and Severity of Dose-limiting toxicity （DLT） (time frame: up to 28 days after last dose of study drug). 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 14 Mar 2023.