REGN7508 to prevent blood clots in adults with solid tumors
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess Efficacy and Safety of REGN7508, a Monoclonal Antibody Against FXI, for Primary Prophylaxis of Cancer-Associated Thrombosis for Participants With Solid Tumors Undergoing Cancer Treatment (ROXI-CAT-I)
This study will test whether the experimental drug REGN7508 can prevent cancer-associated blood clots in adults with solid tumors who are receiving or about to start anticancer treatment or recovering from surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 860 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Regeneron Pharmaceuticals Industry-sponsored |
| Locations | 12 sites (Hialeah, Florida and 11 other locations) |
| Trial ID | NCT07410117 on ClinicalTrials.gov |
What this trial studies
This is a Phase 3, randomized, placebo-controlled study comparing REGN7508 to placebo for prevention of cancer-associated thrombosis in adults with locally advanced or metastatic solid tumors who are at increased clotting risk. Eligible participants have a Khorana score of 2 or greater or a tumor genetic variant linked to higher VTE risk and an ECOG performance status of 0–2. Participants receive REGN7508 or placebo while receiving anticancer therapy (or shortly before/after such therapy) and are monitored for new venous or arterial thromboembolic events, adverse events, drug levels in blood, and anti-drug antibodies. The trial is being conducted at multiple clinical research sites in the United States.
Who should consider this trial
Good fit: Adults with histologically confirmed locally advanced or metastatic solid tumors, a Khorana score ≥2 or an agreed high-risk tumor genetic variant, ECOG 0–2, and who are receiving, about to start, or recovering from anticancer treatment are the intended participants.
Not a fit: Patients with high baseline bleeding risk (including bleeding disorders or hemorrhagic tumor sites), primary brain tumors or brain metastases, prior documented VTE/ATE, or cancers limited to basal or squamous cell skin carcinoma are excluded and unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, REGN7508 could lower the risk of blood clots in high-risk cancer patients, potentially reducing complications and hospitalizations.
How similar studies have performed: Existing trials of anticoagulants such as LMWH and DOACs have shown benefit in reducing cancer-associated thrombosis, but REGN7508 is a novel investigational agent without established clinical evidence for CAT prevention.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: 1. Has a histologically confirmed diagnosis of malignant solid tumors which are locally advanced or metastatic as described in the protocol 2. Has a Khorana thromboembolic risk score ≥2 at the time of screening or harbors a somatic documented tumor genetic variant known to be associated with an increased risk of VTE as described in the protocol 3. Has an Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2 at the time of screening and day 1 prior to the first dose of study intervention Key Exclusion Criteria: 1. Has known bleeding conditions (eg, Hemophilia A or B, von Willebrand's disease), hemorrhagic tumor sites, or other conditions with a high risk for bleeding (eg, hepatic disease associated with coagulopathy) 2. Has a cancer diagnosis consisting solely of basal cell or squamous cell skin carcinoma 3. Has a primary brain tumor or brain metastases as described in the protocol 4. Has a history of objective evidence of VTE or ATE, including incidental VTE identified by diagnostic imaging requiring anticoagulation 5. Has any condition that, as judged by the investigator, may confound the results of the study or would place the participant at increased risk of harm if he/she participated in the study Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
Where this trial is running
Hialeah, Florida and 11 other locations
- Bioresearch Partner- Hialeah Hospital — Hialeah, Florida, United States (Recruiting)
- Helios Clinical Research — North Miami Beach, Florida, United States (Recruiting)
- El Paso Medical Research Institute (Medresearch Inc) — El Paso, Texas, United States (Recruiting)
- LTD High Technology Hospital Medcenter — Batumi, Adjara, Georgia (Recruiting)
- Krystyna Kiel Oncology Center — Kutaisi, Imereti, Georgia (Recruiting)
- American Hospital Tbilisi — Tbilisi, Georgia (Recruiting)
- Llc Todua Clinic — Tbilisi, Georgia (Recruiting)
- Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic — Tbilisi, Georgia (Recruiting)
- Institute of Clinical Oncology — Tbilisi, Georgia (Recruiting)
- JSC Evex Hospitals - Caraps Medline — Tbilisi, Georgia (Recruiting)
- LTD Cancer Research Centre — Tbilisi, Georgia (Recruiting)
- Caucasus Medical Centre — Tbilisi, Georgia (Recruiting)
Study contacts
- Study coordinator: Clinical Trials Administrator
- Email: clinicaltrials@regeneron.com
- Phone: 844-734-6643
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.