Solid TumorPhase 1NCT04678921
Study of TJ210001 Administered in Subjects With Relapsed or Refractory Advanced Solid Tumors
A Phase 1 study testing TJ210001 in people with Solid Tumor and Metastatic Cancer, run by I-Mab Biopharma US Limited at 4 sites in United States.
Trial summary
This is an open label, multi-center, multiple dose Phase 1 study to evaluate the safety, tolerability, MTD or MAD, PK, and PD of TJ210001 in subjects with relapsed or refractory advanced solid tumors. Beginning with Dose Level 1, TJ210001 will be given every week starting on Cycle 1 Day 1 (C1D1). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Solid Tumor, Metastatic Cancer, Advanced Cancer
- What is being tested?
- TJ210001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 4 sitesUnited States
- Study dates
- 17 Dec 2020to 21 Nov 2022
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females, of any race, age ≥ 18 years;
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1;
- Willingness and ability to consent for self to participate in study and the ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures;
- Histologically confirmed advanced or metastatic cancer in patients who are refractory to or intolerant to all available therapy. Patients who received prior PD-1/PD-L1 checkpoint inhibitor or prior CTLA-4 inhibitor therapy may enroll if they did not experience Grade 3 immune-related toxicity (exceptions may be allowed provided these toxicities have resolved e.g. Grade 3 endocrinopathy that is resolved or clinically stable with hormone replacement therapy). There is no limit to the number of prior treatment regimens;
- At least one measurable lesion as defined by RECIST 1.1;
- Resolution of all acute adverse events resulting from prior cancer therapies to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade ≤ 1 or baseline (except alopecia or neuropathy);
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- Considered by the Investigator to be an appropriate candidate for a Phase 1 clinical study, with a life expectancy of ≥ 12 weeks;
- Adequate organ function as defined by the following criteria:
- Absolute neutrophil count (ANC) ≥ 1500/μL (≥1.5 × 109/L) without growth factor support for 7 days (14 days if on pegfilgrastim) prior to study treatment;
- Platelets ≥ 100,000/μL (≥ 100 ×109/L) without transfusion support within 14 days prior to study treatment;
- Hemoglobin ≥ 9.0 g/dL without transfusion support within 14 days prior to study drug administration (erythropoietin or darbepoetin permitted);
- Adequate renal function and serum creatinine ≤ 1.5 times the ULN or estimated creatinine clearance ≥ 30 mL/min by Cockcroft-Gault equation4;
- Total serum bilirubin ≤ 1.5 times the ULN, unless patient has documented Gilbert's disease in which case bilirubin ≤ 3.0 times the ULN;
- Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5 times upper limit of normal (ULN) or ≤ 5 times ULN in cases of liver metastases
- Albumin ≥ 3.0 g/dL;
- Prothrombin Time (PT) ≤ 1.5 times the ULN, or 11 to 15 seconds in the absence of a normal range; partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 times the ULN; and international normalized ratio (INR) ≤ 1.5 times the ULN unless the subject is receiving anticoagulant therapy.
- Subject with a QT interval corrected for heart rate using Fridericia's formula (QTcF) and/or QT interval corrected for heart rate using Bazett's formula of < 470 msec for both males and females;
- A 28-day washout period after the completion of programmed death-1 (PD-1)/PD-L1 therapy;
- Women of childbearing potential (WOCBP) must:
- Agree to use at least 2 effective contraceptive methods (1 highly effective method in combination with a barrier method; oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner), one of which must be barrier, from signing the ICF, throughout the study, and for up to 12 weeks following the last dose of TJ210001;
- Have a negative serum pregnancy test (sensitive of at least 25 mIU/ml) at screening; and have a negative serum or urine pregnancy test (Investigator's discretion) within 72 hours prior to Cycle 1 Day -1 of study treatment (note that the screening serum pregnancy test can be used as the test prior to Day -1 study treatment if it is performed within the prior 72 hours);
- Avoid conceiving for 12 weeks after the last dose of TJ210001;
- Avoid donation of ova from signing the ICF until 12 weeks after the last dose of TJ210001;
- Agree to ongoing urine pregnancy testing, if clinically indicated, during the course of the study.
- Males must agree to use a condom (a latex condom is recommended) during sexual contact with a pregnant female or a female of childbearing potential and will avoid donation of sperm or having a female partner conceive from the time of signing the ICF, while participating in the study, during dose interruptions, and for at least 12 weeks after the last dose of study treatment, even if he has undergone a successful vasectomy.
Who cannot join
- Has an active autoimmune disease requiring systemic treatment within the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is permitted;
- Current treatment on another therapeutic clinical trial;
- Receipt of systemic anticancer therapy, including investigational agents, within 28 days prior to study treatment (Note: if anticancer therapy was given within 28 days prior to starting study treatment, patients are not excluded if ≥ 5 times the elimination half-life of the drug has elapsed.);
- Prior treatment with C5aR inhibitors;
- Prior T-cell or NK-cell therapy;
- Major surgical procedure or significant traumatic injury within 4 weeks prior to study treatment, and must have fully recovered from any such procedure; and no date of surgery (if applicable) or anticipated need for a major surgical procedure planned within the next 6 months (The following are not considered to be major procedures and are permitted up to 14 days prior to study treatment: thoracentesis, paracentesis, port placement, laparoscopy, thoracoscopy, tube thoracostomy, bronchoscopy, endoscopic ultrasonographic procedures, mediastinoscopy, incisional biopsies, and routine dental procedures. Core biopsy and skin biopsy do not require a waiting period prior to dosing.);
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- Chest radiotherapy ≤ 28 days, wide field radiotherapy ≤ 28 days (defined as > 50% of volume of pelvic bones or equivalent), or limited field radiation for palliation ≤ 14 days prior to study treatment - such patients must have recovered adequately from any side effects of such therapy;
- Hypertension defined as blood pressure (BP) systolic > 150 or diastolic > 90 mm Hg (Note: Initiation or adjustment of antihypertensive medication prior to study dosing is allowed provided that the average of the three most recent BP readings prior to study enrollment is ≤ 150/90 mm Hg.);
- Ascites, pericardial or pleural effusions that required intervention within 1 month prior to study treatment;
- Has known active CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment;
- Any of the following in the previous 6 months: severe/unstable angina, myocardial infarction (MI), symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack (TIA), arterial embolism, pulmonary embolism, percutaneous transluminal coronary angioplasty (PTCA), deep vein thrombosis, coronary artery bypass grafting (CABG), or New York Heart Association (NYHA) Class 3 or 4 congestive heart failure;
- Has a diagnosis of immunodeficiency (known active HIV, hepatitis B virus, hepatitis C virus infection) or is receiving chronic systemic steroid therapy (in dosing exceeding 10mg of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug;
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora, Colorado, 80045
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Horizon Oncology Center
Lafayette, Indiana, 47905
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112
About this study
Official title: A Phase 1 Study of TJ210001 Administered in Subjects With Relapsed or Refractory Advanced Solid Tumors
This is an open label, multi-center, multiple dose Phase 1 study to evaluate the safety, tolerability, MTD or MAD, PK, and PD of TJ210001 in subjects with relapsed or refractory advanced solid tumors. Beginning with Dose Level 1, TJ210001 will be given every week starting on Cycle 1 Day 1 (C1D1). The criteria for dose escalation/de-escalation will be based on the Bayesian optimal interval (BOIN) design with sequentially enrolled cohorts. The BOIN design is implemented in a simple way similar to the traditional 3+3 design but is more flexible and possesses superior operating characteristics that are comparable to those of the more complex model-based designs, such as the continual reassessment method (CRM).
- Conditions
- Solid Tumor, Metastatic Cancer, Advanced Cancer
- Being tested
- TJ210001
- Keywords
- monoclonal antibody, anti-C2aR
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TJ210001Drug
Also called MOR210, MOR044254, WBP2191
human anti-C5aR monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 | Experimental | 1mg/kg Q1W Receives: Drug: TJ210001 |
| Dose Level 2 | Experimental | 3 mg/kg Q1W Receives: Drug: TJ210001 |
| Dose Level 3 | Experimental | 10mg/kg Q1W Receives: Drug: TJ210001 |
| Dose Level 4 | Experimental | 15 mg/kg Q1W Receives: Drug: TJ210001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Adverse Events
The CTCAE criteria will be used to assess adverse events on this trial.
Measured: 90 days post last dose
Maximum Tolerated Dose
Based on DLT Definitions
Measured: 21 days
Secondary outcomes (5)
Pharmacokinetic Profile
Cmax
Measured: 90 days post last dose
Pharmacokinetic Profile
AUC
Measured: 90 days post last dose
Anti-drug Antibodies (ADA)
Incidence of anti-drug antibodies
Measured: 90 days post last dose
Anti-drug Antibodies (ADA)
Concentration of anti-drug antibodies
Measured: 90 days post last dose
Response Rate
RECIST 1.1 will be used to assess response rate on this trial.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start17 Dec 2020
- Primary completion21 Nov 2022
- Study completion21 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- I-Mab Biopharma US Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04678921
- Sponsor's protocol ID
- TJ210001STM101
- Status last verified
- Dec 2022
- First submitted
- 15 Dec 2020
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of TJ210001 Administered in Subjects With Relapsed or Refractory Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04678921
- Acronym / sponsor ID
- TJ210001STM101
- Conditions
- Solid Tumor, Metastatic Cancer, Advanced Cancer
- Keywords
- monoclonal antibody, anti-C2aR
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- I-Mab Biopharma US LimitedIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- 21 Nov 2022 (actual)
- Study completion
- 21 Nov 2022 (actual)
- First posted
- 22 Dec 2020 (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, multi-center, multiple dose Phase 1 study to evaluate the safety, tolerability, MTD or MAD, PK, and PD of TJ210001 in subjects with relapsed or refractory advanced solid tumors. Beginning with Dose Level 1, TJ210001 will be given every week starting on Cycle 1 Day 1 (C1D1). The criteria for dose escalation/de-escalation will be based on the Bayesian optimal interval (BOIN) design with sequentially enrolled cohorts. The BOIN design is implemented in a simple way similar to the traditional 3+3 design but is more flexible and possesses superior operating characteristics that are comparable to those of the more complex model-based designs, such as the continual reassessment method (CRM).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1 | Experimental | Drug: TJ2100011mg/kg Q1W |
| Dose Level 2 | Experimental | Drug: TJ2100013 mg/kg Q1W |
| Dose Level 3 | Experimental | Drug: TJ21000110mg/kg Q1W |
| Dose Level 4 | Experimental | Drug: TJ21000115 mg/kg Q1W |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Males or females, of any race, age ≥ 18 years;
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1;
- Willingness and ability to consent for self to participate in study and the ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures;
- Histologically confirmed advanced or metastatic cancer in patients who are refractory to or intolerant to all available therapy. Patients who received prior PD-1/PD-L1 checkpoint inhibitor or prior CTLA-4 inhibitor therapy may enroll if they did not experience Grade 3 immune-related toxicity (exceptions may be allowed provided these toxicities have resolved e.g. Grade 3 endocrinopathy that is resolved or clinically stable with hormone replacement therapy). There is no limit to the number of prior treatment regimens;
- At least one measurable lesion as defined by RECIST 1.1;
Key exclusion criteria (12 listed)
- Has an active autoimmune disease requiring systemic treatment within the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is permitted;
- Current treatment on another therapeutic clinical trial;
- Receipt of systemic anticancer therapy, including investigational agents, within 28 days prior to study treatment (Note: if anticancer therapy was given within 28 days prior to starting study treatment, patients are not excluded if ≥ 5 times the elimination half-life of the drug has elapsed.);
- Prior treatment with C5aR inhibitors;
- Prior T-cell or NK-cell therapy;
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 |
|---|---|---|
| TJ210001Also: MOR210, MOR044254, WBP2191human anti-C5aR monoclonal antibody | Drug | Dose Level 1, Dose Level 2, Dose Level 3, Dose Level 4 |
Primary outcome
Incidence and Severity of Adverse Events
Time frame: 90 days post last dose
The CTCAE criteria will be used to assess adverse events on this trial.
Maximum Tolerated Dose
Time frame: 21 days
Based on DLT Definitions
5 secondary outcomes
Pharmacokinetic Profile
Time frame: 90 days post last dose
Pharmacokinetic Profile
Time frame: 90 days post last dose
Anti-drug Antibodies (ADA)
Time frame: 90 days post last dose
Anti-drug Antibodies (ADA)
Time frame: 90 days post last dose
Response Rate
Time frame: Up to 2 years
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 12 Dec 2022.
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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.
4 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 TJ210001 in people with Solid Tumor and Metastatic Cancer, run by I-Mab Biopharma US Limited at 4 sites in United States.
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 25 inclusion and 12 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 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
Incidence and Severity of Adverse Events (time frame: 90 days post last dose). 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 12 Dec 2022.