TJ033721 for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called TJ033721 (givastomig) for individuals with advanced or metastatic solid tumors, where the cancer has spread and does not respond to standard treatments. The trial evaluates the safety and tolerance of the treatment, administered alone or with other medications like nivolumab and chemotherapy. Suitable candidates have a solid tumor unresponsive to usual treatments or are receiving treatment for the first time for certain stomach or esophageal cancers. For those with a tumor marked by CLDN18.2, this trial could be an option. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that TJ033721, also known as givastomig, is generally safe in early studies. When tested alone in patients with advanced solid tumors, it demonstrated a tolerable safety profile, with side effects remaining manageable even as doses increased.
Givastomig, when combined with nivolumab and chemotherapy, also appeared safe. This combination was tested at various dose levels without reaching a point where side effects became too severe.
Overall, early findings suggest that givastomig, whether used alone or with other treatments, is generally well-tolerated in patients with advanced cancer. However, as these findings are based on early research, further studies are necessary to confirm these results.12345Why are researchers excited about this trial's treatments?
Researchers are excited about TJ033721, also known as givastomig, because it offers a novel approach to cancer treatment by targeting specific mechanisms that are not addressed by standard therapies, like chemotherapy and immunotherapy drugs such as pembrolizumab or nivolumab alone. Unlike traditional options, TJ033721 is designed to be administered at various precise dose levels, which may allow for tailored treatment regimens that optimize effectiveness and minimize side effects. Furthermore, TJ033721 can be combined with nivolumab and chemotherapy, potentially enhancing the overall treatment efficacy by leveraging multiple mechanisms of action against cancer cells. This combination approach and dosing flexibility represent a significant advancement in the potential for personalized cancer care.
What evidence suggests that this trial's treatments could be effective for cancer?
Research has shown that TJ033721, also known as givastomig, may help treat advanced cancers. In earlier studies, givastomig alone shrank tumors in 18% of patients. In this trial, some participants will receive givastomig alone, while others will receive it with nivolumab and chemotherapy. Specifically, when givastomig was combined with nivolumab and chemotherapy, 71% of patients experienced tumor shrinkage. This suggests that adding givastomig to other cancer treatments might enhance their effectiveness. These early results indicate that givastomig could be a valuable option for patients with advanced solid tumors.23467
Are You a Good Fit for This Trial?
This trial is for adults with advanced or metastatic solid tumors, including stomach and esophageal cancers, who have no standard treatment options left. They must be relatively healthy (ECOG status 0 or 1), have CLDN18.2-positive tumor expression, known PD-L1 status, and adequate organ function.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive TJ033721 (givastomig) at various dose levels, with some receiving it in combination with nivolumab and chemotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and pharmacokinetic parameters
What Are the Treatments Tested in This Trial?
Interventions
- TJ033721
Find a Clinic Near You
Who Is Running the Clinical Trial?
I-Mab Biopharma US Limited
Lead Sponsor
I-Mab Biopharma Co. Ltd.
Lead Sponsor
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania