Is NCT07652242 recruiting in Grand Rapids, MI?

Yes, NCT07652242 is currently recruiting participants at its Grand Rapids, MI location. This triple negative breast cancer (tnbc) clinical trial is actively enrolling qualified participants.

Is participation in this Grand Rapids clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Triple Negative Breast Cancer (TNBC) Clinical Trial in Grand Rapids, MI

Q: How do I join the triple negative breast cancer (tnbc) clinical trial in Grand Rapids?

To join this clinical trial in Grand Rapids, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Triple Negative Breast Cancer (TNBC) Study in Grand Rapids

This study tests an investigational cancer vaccine called ITI-5000 in people who have completed standard treatment for early-stage triple-negative breast cancer (TNBC). ITI-5000 is a self-amplifying RNA (saRNA) vaccine that instructs the immune system to recognize and attack cancer cells expressing two proteins found on TNBC cells-HERV-K and CT83-fused with a molecule called LAMP-1 that helps the immune system respond more strongly. The vaccine is delivered inside lipid nanoparticles (LNPs), similar to other approved mRNA vaccines. The study has two parts: * Part A: Participants receive ITI-5000 alone at one of two dose levels (1 µg or 10 µg), given as an injection into the upper arm muscle every 28 days for 3 doses total. The goal is to find the safest dose. * Part B: Participants receive ITI-5000 at the best dose identified in Part A, combined with an approved immunotherapy drug called pembrolizumab (Keytruda®), every 21 days for 3 doses total.

Sponsor: Immunomic Therapeutics, Inc.

Who Can Participate

Inclusion Criteria

Age: Adults aged 18 years or over.

Consent: Provided a signed and dated informed consent form (ICF).

Diagnosis: Histologically confirmed stage 2-3 triple-negative breast cancer (TNBC), defined as HER2-negative, ER-negative, and PgR-negative by immunohistochemistry. BRCA mutations are allowed.

Prior Treatment: Completed all planned standard therapy (surgery, chemotherapy, radiation, and/or pembrolizumab as applicable) and be within 36 months of definitive surgery.

Performance Status: ECOG performance status of 0 or 1.

Organ Function: Adequate organ function at baseline (hematology, biochemistry, etc.).

Cardiac Function: No significant ischemic heart disease or myocardial infarction within 3 months before vaccination #1; QTc ≤470 msec for females or ≤450 msec for males.

Pregnancy: Women of childbearing potential must have a negative serum pregnancy test within 3 days before vaccination #1 and agree to use highly effective contraception during the study and for 123 (Part A) or 137 (Part B) days after last study drug.

Compliance: Able to attend required study visits and follow-up.

Understanding: Able to understand and provide signed informed consent per IRB/IEC guidelines.

Vaccinations: Agrees not to receive routine vaccinations until at least 30 days after the last study vaccine.

Alternative Therapies: Agrees not to use alternative therapies from the time of informed consent through 30 days following vaccination #3.

Exclusion Criteria

Part B only: Discontinued prior treatment with an immune checkpoint inhibitor (ICI) due to immune-related adverse events (irAEs).

Recent Surgery/Therapy: Major surgery within 4 weeks before vaccination #1 or received cancer-directed therapy or investigational drug/device within 4 weeks or 5 half-lives before vaccination #1.

Part B only: Received other PD-1/PD-L1 inhibitors (besides pembrolizumab) without proper washout.

Toxicities: Unresolved toxicities from prior immunotherapy or chemotherapy (must be ≤ Grade 1 or baseline, or deemed irreversible and not worsened by immunotherapy).

Medical Illness: Significant medical illness, underlying health condition, or abnormal laboratory finding increasing risk.

Autoimmune Disease: Active autoimmune disease requiring immunosuppressive treatment within the last year.

Pregnancy/Lactation: Female participants trying to conceive, pregnant, or lactating.

Positive Pregnancy Test: Positive serum pregnancy test at screening or positive urine test at baseline.

Other Trials: Concurrent participation in any other interventional clinical trial.

Allergies: Known allergies to any components of the study vaccine.

Anaphylaxis: History of anaphylaxis requiring medical intervention (including severe reactions to other mRNA vaccines).

Cardiac History: History of stroke, transient ischemic attack, unstable angina, or myocardial infarction within 3 months prior to first dose.

Myocarditis/Pericarditis: History of myocarditis or pericarditis.

Heart Failure: Symptomatic congestive heart failure (NYHA Class III or IV), significant arrhythmia, or LVEF \<45%.

QT Risk: History of risk factors for torsade de pointes or use of QT-prolonging medications.

Vaccines: Received mRNA or live virus vaccine within 28 days of planned vaccination #1 (flu and COVID boosters prohibited in that window).

Prior Malignancy: Prior malignancy except adequately treated basal/squamous cell skin cancer, in situ cervical cancer, or disease-free for ≥3 years.

Organ Transplant: History of organ transplant requiring immunosuppression; unstable HIV/AIDS.

Hepatitis: Known active hepatitis B or C.

Compliance: Unable or unwilling to comply with study schedule/procedures.

Injection/Blood Draw: Contraindication to IM injections or blood draws.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Grand Rapids?

Yes, this clinical trial (NCT07652242) has an active research site in Grand Rapids, MI that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Triple Negative Breast Cancer (TNBC) Treatment Options in Grand Rapids, MI

If you're searching for triple negative breast cancer (tnbc) treatment options in Grand Rapids, MI, this clinical trial (NCT07652242) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Grand Rapids research site is actively enrolling participants for this clinical trial. You'll receive care from experienced triple negative breast cancer (tnbc) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all triple negative breast cancer (tnbc) clinical trials near you to find additional studies recruiting in your area.

Triple Negative Breast Cancer (TNBC) Clinical Trial in Grand Rapids, MI

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