Is NCT06589440 recruiting in Morristown, NJ?

Yes, NCT06589440 is currently recruiting participants at its Morristown, NJ location. This colorectal cancer clinical trial is actively enrolling qualified participants.

How do I join the colorectal cancer clinical trial in Morristown?

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

Is participation in this Morristown 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.

Colorectal Cancer Clinical Trial in Morristown, NJ

About This Colorectal Cancer Study in Morristown

This is an open-label, dose escalation and expansion, multi-center phase 2 study evaluating the safety and efficacy of SR-8541A administered orally in combination with intravenous botensilimab and balstilimab in subjects with MSS-CRC with and without active liver metastases.

Sponsor: Stingray Therapeutics

Who Can Participate

Inclusion Criteria

Written informed consent from subject

Age ≥ 18 years old on the date of consent

Histologically confirmed diagnosis of unresectable and metastatic adenocarcinoma of the colon or rectum

Non-microsatellite instability high or non-deficient mismatch repair (non-MSI-H/non-dMMR) tumor status per a standard local testing method

Must have received at least 1 prior chemotherapy regimen for metastatic or recurrent CRC

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Measurable disease per RECIST v1.1 (Eisenhauer et al., 2009)

Able to provide archival or fresh tumor tissue during screening (required) and post-treatment (optional)

Adequate renal function defined as creatinine clearance ≥ 60mL/min

Adequate liver function

Adequate hematologic function

No growth factor support, transfusions, or albumin administration within 14 days of first dose of study treatment

Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Male and female subjects of childbearing potential must agree to use a highly medically effective method of contraception and refrain from sperm/egg donation throughout the study starting with the first dose of study treatment (or 14 days prior to the first dose of study treatment for oral contraception) and for at least 3 months after the last dose of study treatment

Exclusion Criteria

Hypersensitivity or allergy to any of the study drugs or their excipients.

In Part 2, Cohort A, active liver metastases by computed topography (CT) or magnetic resonance imaging (MRI).

Treatment with one of the following classes of drugs within the delineated time window prior to first dose:

Small molecule/tyrosine kinase inhibitors within 2 weeks

Any other systemic therapy for CRC within 3 weeks

Received another investigational drug within 30 days or active participation in another clinical trial (follow-up is permitted)

Medications/products which are known strong inhibitors or inducers of the CYP enzymes within 5 x T1/2

Received programmed cell death protein 1, PD-(L)1, or CTLA-4 therapies including any immune checkpoint inhibitor or experimental immunologic agents.

Partial or complete bowel obstruction within the last 3 months, signs/symptoms of bowel obstruction, or known radiologic evidence of impending obstruction.

Refractory ascites.

Current evidence of interstitial lung disease (ILD) or pneumonitis, or prior history of ILD or non-infectious pneumonitis requiring glucocorticoids.

Continuous systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 28 days prior to Day 1.

Active autoimmune disease that has required systemic treatment in past 2 years

Patients with adrenal / pituitary insufficiency

History of documented congestive heart failure; unstable angina; poorly controlled hypertension; clinically significant valvular heart disease; high-risk uncontrolled arrhythmias (including sustained ventricular tachycardia); myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack within the last 6 months, or Canadian Cardiovascular Society angina class \> 2

History of allogeneic organ transplant, stem cell transplant, or bone marrow transplant

Previous SARS-CoV-2 infection within 10 days for mild or asymptomatic infections or 20 days for severe/critical illness prior to first dose

Requirement for treatment with strong cytochrome P450 3A4 inducers or inhibitors

Presence of gastrointestinal condition, for example, malabsorption, that might affect the absorption of Investigational Product(s).

Troponin I \> ULN

Uncontrolled hypertension

Corrected QT interval by Fridericia (QTcF) ≥ 470 ms per the central mean average of triplicate electrocardiograms (ECGs)

Left Ventricular Ejection Fraction (LVEF) \< 50% using echocardiogram or multigated acquisition (MUGA)

Symptomatic uncontrolled central nervous system (CNS) disease requiring treatment with steroids or anti-seizure medications within 2 months prior to Day 1. However, subjects with brain metastases that have been previously treated and are stable based on imaging performed within 2 months of Day 1 following completion of any CNS-directed therapy are allowed

Leptomeningeal disease

Spinal cord compression not definitively treated with surgery and/or radiation

Bleeding diathesis due to underlying medical condition or anticoagulation medication which is unable to be promptly reversed by medical treatment

Prior additional malignancy that is progressing or has received treatment the previous 3 years prior to first dose except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast

History of uncontrolled seizures, central nervous disorders, substance abuse disorder or psychiatric disability judged by the Investigator to be clinically significant and would interfere with cooperation with requirements of the study

Active infection requiring systemic treatment at time of first dose

Positive for human immunodeficiency virus (HIV) (HIV antibodies) or active hepatitis B (e.g., HbsAg reactive) or active hepatitis C (e.g., HCV ribonucleic acid \[RNA\] qualitative) infection with detectable viral load

Pregnant or lactating females who plan to nurse a child during or within 3 months of the last dose of study treatment

Major surgery within 28 days prior to first dose and/or minor surgery (excluding biopsy) within 7 days prior to first dose. Note: If the subject had major surgery, the subject must have recovered adequately from the procedure and/or any complications from the surgery prior to starting study intervention

Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the Investigator's opinion, could affect the safety of the subject or impair the assessment of study results

Planned use of any of the prohibited concomitant medications

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 Morristown?

Yes, this clinical trial (NCT06589440) has an active research site in Morristown, NJ 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.

Colorectal Cancer Treatment Options in Morristown, NJ

If you're searching for colorectal cancer treatment options in Morristown, NJ, this clinical trial (NCT06589440) 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 Morristown research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced colorectal cancer 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 colorectal cancer clinical trials near you to find additional studies recruiting in your area.

Colorectal Cancer Clinical Trial in Morristown, NJ

Expert Care in Morristown

IRB Approved

No-Cost Care

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