- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05511350
Expanded Access Protocol for Subjects With Relapsed or Refractory Advanced Solid Tumors Receiving TJ210001
October 14, 2022 updated by: I-Mab Biopharma Co. Ltd.
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.
Study Overview
Status
No longer available
Intervention / Treatment
Study Type
Expanded Access
Expanded Access Type
- Individual Patients
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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;
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Laura Feller, NP, Horizon Oncology Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
August 19, 2022
First Submitted That Met QC Criteria
August 19, 2022
First Posted (ACTUAL)
August 23, 2022
Study Record Updates
Last Update Posted (ACTUAL)
October 18, 2022
Last Update Submitted That Met QC Criteria
October 14, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TJ210001STM103
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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