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New treatment option for Gastric Cancer
Official title CA-4948 in Combination With FOLFOX/PD-1 Inhibitor +/- Trastuzumab for Untreated Unresectable Gastric and Esophageal Cancer
ClinicalTrials.gov ID: NCT05187182
What this study is testing
What is CA-4948?
CA-4948 is an investigational medicine, being studied as a potential treatment for gastric cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Advanced unresectable or metastatic histologically or cytologically confirmed adenocarcinoma or squamous cell carcinoma of the stomach...
- 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.
You likely can't join if
- Current use or anticipated need for alternative, holistic, naturopathic, or botanical formulations used for the purpose of cancer treatment. Use of...
- A history of other malignancy with the exception of 1) malignancies for which all treatment was completed at least 2 years before registration and...
- 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...
See the full eligibility criteria
Who can join
- 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...
- Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
What rules you out
- 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...
- 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...
- 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 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...
- Patients are unwilling to adhere to the lifestyle guidance in protocol.
The study team makes the final eligibility decision.
Where it's taking place
- St Louis, Missouri, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include St Louis, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.