Is NCT05187182 recruiting in St Louis, MO?

Yes, NCT05187182 is currently recruiting participants at its St Louis, MO location. This gastric cancer clinical trial is actively enrolling qualified participants.

How do I join the gastric cancer clinical trial in St Louis?

To join this clinical trial in St Louis, 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 St Louis 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.

Gastric Cancer Clinical Trial in St Louis, MO

About This Gastric Cancer Study in St Louis

This is a phase I trial of CA-4948 in combination with FOLFOX/PD-1 inhibitor with or without trastuzumab for unresectable gastric, GEJ, and esophageal cancer. During the Dose Escalation portion of the study, different dose levels of CA-4948 in combination with FOLFOX/nivolumab will be evaluated by BOIN algorithm. Dose Expansion will include Cohorts A and B. Expansion Cohort A will enroll up to 12 patients with HER2 negative gastric, GEJ, and esophageal cancer at the expansion dose of CA-4948 determined during Dose Escalation and will use the same treatment regimen of FOLFOX/nivolumab. Expansion Cohort B will investigate CA-4948 at the dose determined during Dose Escalation in combination with FOLFOX/pembrolizumab and trastuzumab in up to 12 patients with HER2 positive disease; however, the initial 6 patients will be considered safety lead-in to confirm the safety and tolerability of this combination; if determined to be safe, an additional 6 patients will be enrolled for a total of 12 in Cohort B.

Sponsor: Washington University School of Medicine

Who Can Participate

Inclusion Criteria

Advanced unresectable or metastatic histologically or cytologically confirmed adenocarcinoma or squamous cell carcinoma of the stomach, gastroesophageal junction, or esophagus

Measurable or evaluable disease defined by RECIST 1.1.

Lesions amenable to research biopsy. This criteria can be waived by the PI after documented discussion with the treating physician.

Known HER2 status if histology is adenocarcinoma prior to enrollment; results from local CLIA laboratory is acceptable.

For Dose Escalation, patients are required to have documented HER2 negative cancer.

For Dose Expansion, patients will be enrolled to either HER2 positive or negative cohorts at the time of enrollment

No prior systemic treatment for unresectable/advanced gastric, GEJ, or esophageal cancer.

Neoadjuvant or adjuvant systemic therapy is allowed; however, surgical resection and adjuvant chemotherapy should have been \> 3 months from planned C1D1.

Up to two prior cycles of FOLFOX is allowed.

Definitive chemoradiation is allowed if the last date of chemotherapy or radiation (whichever is more recent) is \> 3 months from planned C1D1.

Prior palliative radiation therapy, including brain radiation, in the unresectable setting is allowed, but the last treatment date should be \>10 days from planned C1D1.

At least 18 years of age

ECOG performance status 0 or 1

Adequate bone marrow and organ function as defined below:

Absolute neutrophil count ≥ 1.5 K/cumm

Platelets ≥ 100 K/cumm

Hemoglobin ≥ 9.0 g/dL

Total bilirubin ≤ 1.5 x IULN or ≤ 3 x IULN in patients with documented Gilbert's syndrome

AST(SGOT)/ALT(SGPT) ≤ 2.0 x IULN, unless there are liver metastases in which case AST and ALT ≤ 5.0 x IULN

PT/INR ≤ 1.5 x IULN

aPTT ≤ 1.5 x IULN

Creatinine clearance ≥ 35 mL/min by Cockcroft-Gault

Creatinine phosphokinase (CPK) elevation at screening \< Grade 2 (CPK \< 2.5 x IULN)

Patients on a cholesterol lowering statin must be on a stable dose with no dose changes within 3 weeks prior to study start.

Expansion Cohort B patients only: LVEF above LLN as assessed by MUGA or ECHO

The effects of CA-4948 on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and 3 months after completion of the study

Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria

Current use or anticipated need for alternative, holistic, naturopathic, or botanical formulations used for the purpose of cancer treatment. Use of medical marijuana is permitted.

A history of other malignancy with the exception of 1) malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease; 2) or known indolent malignancies that do not require treatment and will likely not alter the course of treatment of metastatic gastric, GEJ, or esophageal cancer.

History of allogeneic organ or stem cell transplant

Currently receiving any other investigational therapeutic agents. Investigational tracers related to imaging studies are allowed with a 7 day-washout.

Currently have an intraluminal GI stent (gastric, esophageal, small bowel, colon). Biliary stents are allowed.

History of clinically relevant bleeding from their tumor(s). Includes but is not limited to bleeding tumor requiring RBC transfusion, or bleeding requiring more than one endoscopic intervention.

Untreated ulcerating tumor. Patients who are endoscopically treated must be assessed by the study PI or delegate for eligibility.

Use of systemic therapeutic anticoagulation, including daily baby aspirin, within 5 half-lives of the anticoagulant prior to C1D1. Patients can receive heparin or alteplase flush in their ports.

Use of anti-platelet therapies (i.e. P2Y12 inhibitors (clopidogrel, prasugrel, etc.), within 5 half-lives of the anti-platelet therapy prior to C1D1.

Use of NSAIDs within 5 half-lives of the NSAID prior to C1D1.

Clinically active CNS metastasis; treated and asymptomatic metastasis allowed at the discretion of the PI. Radiotherapy to the brain must be completed \> 10 days prior to planned C1D1.

A history of allergic reactions attributed to compounds of similar chemical or biologic composition to CA-4948, FOLFOX, nivolumab, trastuzumab or other agents used in the study.

Concomitant use of drugs with a known risk of causing prolonged QTc and/or Torsades de Pointes or a history of risk factors for Torsades de Pointes.

Presence of interstitial lung disease or pneumonitis ≥ G2

Administration of a live attenuated vaccine within 30 days prior to enrollment.

QTc (Bazett) \>470ms on screening EKG

Gastrointestinal condition which could impair absorption of CA-4948 or inability to ingest CA-4948

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia

Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 7 days of study entry.

Patients with HIV are eligible unless their CD4+ T-cell counts are \< 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended. Recommend exclusion of specific ART agents based on predicted drug-drug interactions (i.e., for sensitive CYP3A4 substrates, concurrent strong CYP3A4 inhibitors (ritonavir and cobicistat) or inducers (efavirenz) should be contraindicated).

Participants with active, known or suspected autoimmune disease. Participants with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, euthyroid participants with a history of Grave's disease (participants with suspected autoimmune thyroid disorders must be negative for thyroglobulin and thyroid peroxidase antibodies and thyroid stimulating immunoglobulin prior to first dose of study treatment), psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll after discussing with the PI.

Participants with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study treatment except for adrenal replacement steroid doses \> 10 mg daily prednisone equivalent in the absence of active autoimmune disease. Note: treatment with a short course of steroids (\< 5 days) up to 7 days prior to initiating study treatment is permitted. Inhaled intranasal, intra-articular, and topical steroid uses are permitted.

Patients are unwilling to adhere to the lifestyle guidance in protocol.

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 St Louis?

Yes, this clinical trial (NCT05187182) has an active research site in St Louis, MO 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.

Gastric Cancer Treatment Options in St Louis, MO

If you're searching for gastric cancer treatment options in St Louis, MO, this clinical trial (NCT05187182) 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 St Louis research site is actively enrolling participants for this clinical trial. You'll receive care from experienced gastric 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 gastric cancer clinical trials near you to find additional studies recruiting in your area.

Gastric Cancer Clinical Trial in St Louis, MO

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