Solid Tumor Metastatic Cancer Advanced CancerNCT05511350
Expanded Access Protocol for Subjects With Relapsed or Refractory Advanced Solid Tumors Receiving TJ210001
A study testing TJ210001 in people with Solid Tumor Metastatic Cancer Advanced Cancer, run by I-Mab Biopharma US Limited.
Trial summary
This EAP was designed to provide TJ210001 to the remaining subjects with relapsed or refractory solid tumors who were enrolled on the parent study, TJ210001STM101 (NCT04678921), and plan to continue with treatment. 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
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Adult, Older adult
Who may be able to join
- Males or females, of any race, age ≥ 18 years;
- Participation in the parent TJ210001STM101 study and thought to have potential to derive clinical benefit from continued treatment in the opinion of the parent study investigator from uninterrupted dosing of TJ210001;
- Willingness and ability to comply study treatment and standard of care testing and procedures;
- 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;
- Avoid conceiving for 12 weeks after the last dose of TJ210001;
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- Avoid donation of ova 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;
- Patient or patient's health care proxy is able and willing to provide written informed consent and able to follow study instructions.
Who cannot join
- Any unresolved ongoing toxicity or clinical event that would make continued treatment with TJ210001 inappropriate; 2. Current treatment on another therapeutic clinical trial; 3. Currently pregnant; 4. Current evidence of any condition (including medical, psychiatric or substance abuse disorder), therapy, or laboratory abnormality that might interfere with the patient's participation or is not in the best interest of the patient to participate, in the opinion of the treating Investigator
About this study
Official title: An Expanded Access Protocol for Subjects With Relapsed or Refractory Advanced Solid Tumors Receiving TJ210001
This EAP was designed to provide TJ210001 to the remaining subjects with relapsed or refractory solid tumors who were enrolled on the parent study, TJ210001STM101 (NCT04678921), and plan to continue with treatment.
- Being tested
- TJ210001
- Keywords
- monoclonal antibody anti-C2aR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TJ210001Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor Metastatic Cancer Advanced CancerStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- I-Mab Biopharma US Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laura Feller, NP, Principal investigator, Horizon Oncology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511350
- Sponsor's protocol ID
- TJ210001STM103
- Status last verified
- Oct 2022
- First submitted
- 19 Aug 2022
- Last updated
- 18 Oct 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Expanded Access Protocol for Subjects With Relapsed or Refractory Advanced Solid Tumors Receiving TJ210001
- ClinicalTrials.gov ID
- NCT05511350
- Acronym / sponsor ID
- TJ210001STM103
- Keywords
- monoclonal antibody anti-C2aR
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- I-Mab Biopharma US LimitedIndustry (pharma, biotech, devices)
- First posted
- 23 Aug 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.
This EAP was designed to provide TJ210001 to the remaining subjects with relapsed or refractory solid tumors who were enrolled on the parent study, TJ210001STM101 (NCT04678921), and plan to continue with treatment.
Study design
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Males or females, of any race, age ≥ 18 years;
- Participation in the parent TJ210001STM101 study and thought to have potential to derive clinical benefit from continued treatment in the opinion of the parent study investigator from uninterrupted dosing of TJ210001;
- Willingness and ability to comply study treatment and standard of care testing and procedures;
- Women of childbearing potential (WOCBP) must:
- 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;
Key exclusion criteria (1 listed)
- Any unresolved ongoing toxicity or clinical event that would make continued treatment with TJ210001 inappropriate; 2. Current treatment on another therapeutic clinical trial; 3. Currently pregnant; 4. Current evidence of any condition (including medical, psychiatric or substance abuse disorder), therapy, or laboratory abnormality that might interfere with the patient's participation or is not in the best interest of the patient to participate, in the opinion of the treating Investigator
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 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 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.
Laura Feller, NP principal investigator
Horizon Oncology Center
Questions about this trial
What is this clinical trial studying?
A study testing TJ210001 in people with Solid Tumor Metastatic Cancer Advanced Cancer, run by I-Mab Biopharma US Limited.
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 10 inclusion and 1 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 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
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.
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 18 Oct 2022.