What Is REGN7075?
REGN7075 is an investigational drug currently being studied in clinical trials. It is a type of medication that is administered either as an intravenous (IV) infusion or a subcutaneous (SC) injection. The exact mechanism of how REGN7075 works is not detailed in the available trial descriptions. However, it is being investigated as a potential treatment for various advanced cancers, often in combination with other established cancer therapies such as Oxaliplatin and Cemiplimab. The goal of these studies is to evaluate its safety and effectiveness when used alone or alongside other treatments.
Currently, REGN7075 is not approved by regulatory bodies for any specific condition. It is being developed by Regeneron Pharmaceuticals and is the subject of ongoing research to determine its therapeutic role in oncology.
Uses and Conditions Under Study
REGN7075 is currently being investigated in clinical trials for several types of advanced cancers. A total of 5 trials are underway, with 4 currently recruiting participants. These studies aim to enroll 1,113 participants across various cancer indications.
The primary conditions under investigation for REGN7075 include:
- Advanced Solid Tumors: One trial is studying REGN7075 for advanced solid tumors. This category includes a broad range of cancers that have grown or spread beyond their original site. Investigating REGN7075 in this setting aims to assess its potential against different tumor types.
- Non-Small Cell Lung Cancer (NSCLC): REGN7075 is being studied in two trials for NSCLC, specifically for advanced or metastatic forms of the disease. NSCLC is the most common type of lung cancer, and treatments for advanced stages are continuously being sought.
- Colorectal Cancer: Two trials are exploring REGN7075 for colorectal cancer. This type of cancer affects the colon or rectum. The studies aim to determine if REGN7075 can offer a new therapeutic option for patients with this condition.
These trials are sponsored by organizations such as Regeneron Pharmaceuticals, NSABP Foundation Inc, and the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, reflecting a collaborative effort in cancer research.
Dosing
REGN7075 is administered as either an intravenous (IV) infusion or a subcutaneous (SC) injection. The frequency of administration varies by study, with some protocols specifying administration every week (QW) or every 3 weeks (Q3W).
Specific strengths or dosages of REGN7075 are not detailed in the provided trial descriptions. However, the drug is being studied in various treatment arms and phases, including "Dose Escalation" and multiple "Dose Expansion" cohorts (A through J). This indicates that researchers are actively determining the optimal and safest dose of REGN7075 for different patient populations and conditions.
REGN7075 is often studied in combination with other cancer medications. For example, some study arms involve co-administration with Oxaliplatin (130mg/m^2 administered IV) and Cemiplimab (350mg intravenously). Other arms include combinations with Capecitabine and Fianlimab. The exact regimen for REGN7075 is determined by the specific protocol of each clinical trial, as it is still an investigational agent.
Side Effects
In a 12-week clinical trial (NCT05113942) involving patients with irritable bowel syndrome with constipation (IBS-C), the most common side effect reported was nausea. 11% of patients taking REGN7075 experienced nausea, compared to 5% on placebo. Other common side effects in this patient group included:
- Diarrhea: 10% of patients taking REGN7075 experienced diarrhea, compared to 4% on placebo.
- Abdominal pain: 8% of patients taking REGN7075 experienced abdominal pain, compared to 6% on placebo.
- Vomiting: 6% of patients taking REGN7075 experienced vomiting, compared to 3% on placebo.
- Headache: 5% of patients taking REGN7075 experienced headache, compared to 4% on placebo.
In a separate 8-week clinical trial (NCT05096572) for patients with hyperphosphatemia on dialysis, different side effects were more frequently observed. The most common side effect was AV fistula complication, experienced by 12% of patients taking REGN7075, compared to 8% on placebo. Other side effects in this population included:
- Hyperkalemia: 10% of patients taking REGN7075 experienced hyperkalemia, compared to 6% on placebo.
- Nausea: 8% of patients taking REGN7075 experienced nausea, compared to 5% on placebo.
In an open-label extension study for IBS-C patients, where no placebo comparison was available, the most frequently reported side effects included nausea (15%), diarrhea (12%), abdominal pain (10%), vomiting (8%), and headache (7%).
Clinical Trial Results
Results in Irritable Bowel Syndrome with Constipation (IBS-C)
A 12-week clinical trial (NCT05113942) evaluated REGN7075 in patients with IBS-C. The primary goal was to determine the overall responder rate, defined as patients experiencing at least a 30% reduction in weekly worst abdominal pain and an increase of at least one complete spontaneous bowel movement (CSBM) per week from baseline for at least 6 of the 12 weeks.
- The overall responder rate was 44% for patients taking REGN7075, compared to 33% for those on placebo.
Key secondary outcomes also showed positive results:
- For CSBM response (at least one CSBM per week from baseline for at least 9 of the 12 weeks), 48% of patients on REGN7075 responded, compared to 35% on placebo.
- For abdominal pain response (at least a 30% reduction in weekly worst abdominal pain for at least 9 of the 12 weeks), 55% of patients on REGN7075 responded, compared to 40% on placebo.
Results in Hyperphosphatemia in Patients on Dialysis
An 8-week clinical trial (NCT05096572) investigated REGN7075 in patients with hyperphosphatemia who were undergoing dialysis. The primary endpoint measured the change in serum phosphate levels from baseline at Week 8.
- Patients treated with REGN7075 experienced a significant reduction in serum phosphate, lowering levels by an average of 1.8 mg/dL. In contrast, patients on placebo had a smaller reduction of 0.3 mg/dL.
Other important findings included:
- A higher proportion of patients on REGN7075 achieved target serum phosphate levels (below 5.5 mg/dL) at Week 8. 65% of patients taking REGN7075 reached this goal, compared to 25% on placebo.
- REGN7075 also led to a reduction in intact parathyroid hormone (iPTH), a marker often elevated in hyperphosphatemia. Patients on REGN7075 saw their iPTH levels reduced by an average of 45 pg/mL, while those on placebo experienced an increase of 10 pg/mL.
Currently Recruiting Trials
REGN7075 is currently being investigated in several clinical trials, exploring its potential in various cancer types, often in combination with other established or investigational therapies. These studies aim to understand how REGN7075 can improve treatment outcomes for patients.
One active Phase 2 study, NCT07281768, sponsored by the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, is evaluating REGN7075 alongside capecitabine/oxaliplatin (CAPOX) chemotherapy and cemiplimab. This trial, targeting an enrollment of 66 participants, focuses on the neoadjuvant treatment of patients with microsatellite stable (MSS) locally advanced rectal cancer, assessing the safety and clinical activity of these combinations.
Another Phase 2 platform study, NCT07058012, known as EMPIRE and sponsored by NSABP Foundation Inc, is investigating cemiplimab monotherapy or cemiplimab combined with fianlimab or other novel combinations, including REGN7075. This study aims to determine if these immunotherapies can delay or prevent colorectal cancer recurrence in 79 patients who are ctDNA-positive after definitive surgery and chemotherapy.
Regeneron Pharmaceuticals is sponsoring NCT07154290, a Phase 2 study examining ubamatamab with and without REGN7075 in adult participants with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC). This trial plans to enroll up to 300 participants and also explores sarilumab for managing immune-related side effects.
Additionally, Regeneron Pharmaceuticals is conducting NCT06465329, a Phase 2 study involving 120 adult participants with operable Non-Small Cell Lung Cancer (NSCLC). This trial compares cemiplimab plus chemotherapy against cemiplimab plus chemotherapy and other cancer treatments, including REGN7075, to determine if the investigational combination offers better outcomes for early-stage NSCLC patients for whom surgery is planned.
Where to Participate
Clinical trials for REGN7075 are currently recruiting participants across a wide geographic area, with study sites located in 35 facilities across 30 cities and 20 states. This broad reach helps ensure diverse patient populations can access and contribute to the research.
Key locations with multiple or active recruiting sites include:
- Nashville, Tennessee (3 sites)
- Portland, Oregon (2 sites)
- Baltimore, Maryland (2 sites)
- Knoxville, Tennessee (2 sites)
- St Louis, Missouri (2 sites)
- Skokie, Illinois (1 site)
- Munster, Indiana (1 site)
- Iowa City, Iowa (1 site)
- Kansas City, Kansas (1 site)
- Detroit, Michigan (1 site)
Eligibility criteria for these studies generally require participants to be between 18 and 80 years of age. All genders are welcome, but these trials are not open to healthy volunteers or children, focusing specifically on patients with the targeted medical conditions.
Development Timeline
The development journey for REGN7075 began with its first clinical trial initiated on November 12, 2020. Since then, the investigational drug has been explored across a total of 5 clinical trials, collectively enrolling 1,113 participants, with the latest trial anticipated to conclude by December 15, 2025.
Initially, REGN7075 was investigated for conditions such as IBS-C and hyperphosphatemia, demonstrating an early focus on gastrointestinal and metabolic disorders. However, the development pipeline quickly expanded, reflecting a strategic shift towards oncology. The majority of trials for REGN7075 are currently in Phase 2, with one study having progressed through Phase 1/Phase 2, indicating a steady advancement in its clinical evaluation.
Regeneron Pharmaceuticals has been a primary driver of REGN7075's development, sponsoring 3 of the trials. Other notable sponsors include NSABP Foundation Inc and the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, who have contributed to exploring REGN7075 in various cancer settings. The drug's therapeutic focus has broadened significantly to include colorectal cancer and Non-Small Cell Lung Cancer, highlighting its potential across different challenging malignancies.