Ubamatamab + REGN7075 for Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two new drugs, ubamatamab and REGN7075, to determine their effectiveness in treating advanced or metastatic Non-Small Cell Lung Cancer (NSCLC). The study will also examine potential side effects and how these drugs interact with the body over time. Additionally, it will assess whether an additional drug, sarilumab, can help manage immune-related side effects. Individuals with advanced NSCLC who have already tried other standard treatments might be suitable candidates for this trial. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants, offering them a chance to contribute to significant advancements in NSCLC treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that both ubamatamab and REGN7075 hold promise in early studies. Specifically, studies on REGN7075 have examined its safety and effectiveness in treating cancer. About 25% of patients experienced serious side effects, but many tolerated the treatment well and showed positive results in certain cancer types.
Ubamatamab has undergone several trials and is considered to have a safe profile. Patients taking ubamatamab often experienced manageable side effects, and the treatment effectively slowed disease progression.
Both drugs remain under study, but earlier trials suggest they are generally well-tolerated. Participants might experience side effects, but these have mostly been manageable according to the available data.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Ubamatamab and REGN7075 for lung cancer because they offer a fresh approach compared to standard treatments like chemotherapy, surgery, and radiation. Ubamatamab is an innovative monoclonal antibody that targets specific proteins on cancer cells, potentially enhancing the immune system's ability to recognize and destroy those cells. REGN7075, on the other hand, is designed to stimulate the immune system by activating certain immune cells, offering a different mechanism than traditional therapies. Together, these treatments may provide a more targeted and potentially less toxic option for lung cancer patients, sparking interest in their potential effectiveness and safety.
What evidence suggests that this trial's treatments could be effective for Non-Small Cell Lung Cancer?
This trial will evaluate the effectiveness of Ubamatamab and REGN7075 for lung cancer. Research has shown that REGN7075 helps the immune system fight cancer, particularly in patients with "cold" tumors, which are usually difficult to treat. Studies have found a 20% response rate and an 80% disease control rate in some cancer types.
Early findings indicate that Ubamatamab can control disease in 57% of cases, with effects lasting about 12 months on average. It works by helping the body's T cells, a type of immune cell, target and destroy cancer cells. While these results are promising, more research is needed to fully understand the potential benefits for lung cancer patients. Participants in this trial will receive either Ubamatamab or REGN7075 in different treatment arms to further explore their effectiveness.12356Who Is on the Research Team?
Clinical Trial Management
Principal Investigator
Regeneron Pharmaceuticals
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ubamatamab and REGN7075 to evaluate their effectiveness and side effects in treating advanced/metastatic NSCLC
Follow-up
Participants are monitored for safety and effectiveness after treatment, including immune-related side effects and antibody development
What Are the Treatments Tested in This Trial?
Interventions
- REGN7075
- Ubamatamab
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Regeneron Pharmaceuticals
Lead Sponsor
Leonard Schleifer
Regeneron Pharmaceuticals
Chief Executive Officer since 1988
MD and PhD in Medicine
George Yancopoulos
Regeneron Pharmaceuticals
Chief Medical Officer since 1997
MD from Harvard Medical School
Citations
A randomized study of neoadjuvant REGN7075 + ...
Early efficacy and pharmacodynamic evidence suggest that REGN7075 can enhance immune responses and antitumor immunity even in “cold” tumors. In ...
P4.11D.04 A Phase 1/2 Study of REGN7075 (EGFRÃ- ...
Here, we focus on three non-small cell lung cancer (NSCLC) cohorts in the dose expansion phase. The study includes a dose escalation (Part 1) ...
3.
investor.regeneron.com
investor.regeneron.com/news-releases/news-release-details/promising-anti-tumor-activity-novel-costimulatory-bispecific/Promising Anti-tumor Activity of Novel Costimulatory ...
REGN7075 is one of the first immunotherapies to demonstrate clinical activity in MSS CRC, including in a patient with liver metastases.
combine-egfr-1 / nct04626635
A phase 1/2 study of REGN7075 in combination with cemiplimab (cemi) in patients (pts) with advanced solid tumors: Efficacy and safety results.
5.
targetedonc.com
targetedonc.com/view/immunotherapy-for-cold-tumors-regn7075-effective-in-early-trialsImmunotherapy for Cold Tumors: REGN7075 Effective in ...
In patients with MSS CRC without liver metastases, the drug showed promising results, with a 20% response rate and an 80% disease control rate.
A phase 1/2 study of REGN7075 (EGFRxCD28 ...
Primary endpoints are safety and tolerability of REGN7075 alone or in combination with cemiplimab for Part 1, and objective response rate per Response ...
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