Putting Patients First
Each and every person in our trials plays a powerful role. We are grateful to the patients and families who have participated in our previous and ongoing clinical studies. We work diligently to protect their privacy, dignity, safety and well-being at all times.
Advancing Clinical Research
At I-Mab, we strive to develop innovative treatments for people with serious blood disorders and cancers.
Company Sponsored Trials
To make progress against cancer possible, we are currently conducting clinical studies globally to test the safety and efficacy of our potential new medicines.
Biomarker Research
Providing the right medicine to the right patient is central to I-Mab’s innovation. Throughout our clinical studies, we create and test approaches to select patients most likely to benefit, to support dose selection, and to enable informed decisions on advancing our therapies to the next phase of testing.
Investigator Sponsored Trials
Consistent with our commitment to scientific innovation and improving patient’s lives, we may provide support for independent investigators to expand scientific knowledge of our treatments by leading their own research projects using our therapies.
Selected Ongoing
Clinical Trials
Givastomig TJ-CD4B
- Phase 1
- Solid Tumors
Study of TJ033721 in Subjects With Advanced or Metastatic Solid Tumors
Learn more at clinicaltrials.govI-Mab Biopharma (NASDAQ: IMAB) strives to address unmet medical needs in oncology using cutting-edge technology to fine-tune the immune network in cancers.
Expanded Access Policy
The U.S. Food and Drug Administration (FDA) has established criteria for the provision of investigational medicines to patients outside of clinical trials (compassionate use/expanded access). Guidance from the FDA provides that expanded access is a potential pathway for a patient when all of the following apply:
- The patient has a serious disease or condition or whose life is immediately threatened by their disease or condition.
- There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
- Patient enrollment in a clinical trial is not possible.
- Potential benefit justifies the potential risks of treatment.
- Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.
For more information about expanded access in the U.S., please visit the FDA website at https://www.fda.gov/news-events/public-health-focus/expanded-access.
Currently, I-Mab is not accepting applications for expanded access of our investigational medicines. For patients seeking access to our investigational medicines before they are approved by a regulatory authority, participation in one of I-Mab’s clinical trials is the most appropriate path. To learn more about available clinical trials by I-Mab, please visit https://clinicaltrials.gov and search by company, disease or medicine.
If you have additional questions, please speak with your physician or contact info@imabbio.com.
Consistent with the 21st Century Cures Act, I-Mab may revise this policy at any time.