A Study of agenT-797 in Combination With Botensilimab, Balstilimab, Ramucirumab, and Paclitaxel for People With Esophageal, Gastric, or Gastro-esophageal Junction Cancer
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| ClinicalTrials.gov Identifier: NCT06251973 |
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Recruitment Status :
Recruiting
First Posted : February 9, 2024
Last Update Posted : April 5, 2024
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Sponsor:
Memorial Sloan Kettering Cancer Center
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
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Brief Summary:
Participants will receive study treatment with agenT-797, botensilimab, balstilimab, ramucirumab, and paclitaxel. When participants start each agent will depend on how their disease is affecting them.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Metastatic Esophageal Carcinoma Advanced Unresectable Gastric Adenocarcinoma Metastatic Gastric Cancer Metastatic Gastroesophageal Junction Adenocarcinoma Metastatic Esophageal Cancer Metastatic Esophageal Adenocarcinoma Metastatic Gastric Adenocarcinoma Metastatic Gastric Carcinoma Unresectable Esophageal Cancer Unresectable Esophageal Adenocarcinoma Unresectable Gastric Carcinoma Unresectable Gastric Adenocarcinoma Unresectable Gastroesophageal Junction Adenocarcinoma | Biological: AgenT-797 Biological: Botensilimab Drug: Balstilimab Drug: Ramucirumab Drug: Paclitaxel | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 38 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase II Study of agenT-797 (Invariant Natural Killer T Cells), Botensilimab, a Novel Fc-enhanced CTLA-4 Inhibitor, Plus Balstilimab (Anti-PD-1) With Ramucirumab and Paclitaxel for Patients With Previously Treated, Advanced Esophageal, Gastric, or Gastro-esophageal Junction Adenocarcinoma |
| Actual Study Start Date : | February 1, 2024 |
| Estimated Primary Completion Date : | August 1, 2027 |
| Estimated Study Completion Date : | August 1, 2027 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Participants diagnoses with Esophageal, Gastric, or Gastro-esophageal Junction Cancer
Participants with measurable disease and with evaluable disease as defined by RECIST v1.1 will be enrolled on this study.
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Biological: AgenT-797
AgenT-797 is an investigational product, composed of allogeneic human unmodified iNKT cells, isolated from mononuclear cell aphaeresis units from healthy donors Biological: Botensilimab Botensilimab is a novel, human, Fc-engineered IgG1 anti-CTLA-4 antibody Drug: Balstilimab Botensilimab is supplied as a sterile, single-use solution for IV administration Drug: Ramucirumab Ramucirumab is a fully human anti-VEGFR2 monoclonal IgG1 antibody (IgG1) that binds with high affinity to the extracellular domain of VEGFR2. Ramucirumab is a part of standard of care treatment for advanced gastric cancer or GEJ adenocarcinoma, after prior treatment with fluoropyrimidine- or platinum-containing chemotherarapy. Drug: Paclitaxel Paclitaxel is widely used across multiple cancer types and is a part of standard of care treatment for advanced EG adenocarcinoma after prior treatment with fluoropyrimidine- or platinum-containing chemotherarapy. |
Primary Outcome Measures :
- Overall Response Rate [ Time Frame: up to 2 years ]Determine the efficacy of agenT-797, botensilimab and balstilimab in combination with ramucirumab and paclitaxel as second-line therapy in patients with advanced unresectable or metastatic esophagogastric cancer, as measured by ORR (defined as the percentage of patients who achieve either an objective complete response [CR] + partial response [PR])
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Metastatic or advanced unresectable adenocarcinoma of esophageal, gastric, or gastroesophageal junction
- Disease progression on one prior line of therapy for metastatic disease
- Patients must have histologically or cytologically confirmed esophageal, gastric, or gastroesophageal junction adenocarcinoma
- Patients must have measurable or evaluable disease as defined by RECIST v1.1 criteria. Patients with evaluable disease must be eligible to begin with an induction cycle
- Age 18 years or older
- ECOG performance status 0 to 1
- Adequate organ function as defined in Table 2
Table 2. Organ function requirements for eligibility Hematological Absolute neutrophil count: ≥1000/mcL Platelets: ≥90,000/mcL Hemoglobin: ≥8 g/dL Renal Serum creatinine: ≤1.5X ULN Hepatic Serum total bilirubin: ≤1.5X ULN OR Direct bilirubin ≤ULN for subjects with total bilirubin levels >1.5X ULN, except patients with Gilbert's disease (≤3X ULN) AST and ALT: ≤2.5X ULN Albumin: ≥3 mg/dL
Exclusion Criteria:
- Received prior therapy with ramucirumab at any time
- Received paclitaxel or docetaxel-based therapy within 6 month of study enrollment
- Had a prior grade >3 immune related adverse event due to anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA4 therapy at any time
- Diagnosis of immunodeficiency or receipt of systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of trial treatment. Replacement therapy (ie physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic immunosuppressive therapy and is allowed.
- History of gastrointestinal perforation or fistulae
- A known history of active Bacillus tuberculosis
- Known active central nervous system metastases and/or carcinomatous meningitis
- History of or any evidence of active, non-infectious pneumonitis
- Peripheral neuropathy limiting ADLs
- A known history of human immunodeficiency virus (HIV 1/2 antibodies)
- Known active hepatitis B (e.g., HBsAg reactive) or hepatitis C (e.g., HCV RNA [qualitative] is detected). Patients with HBsAg reactive on entecavir may be eligible after consultation with hepatologist and study team.
- Received a live vaccine within 30 days of planned start of study therapy
- Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
- Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the prescreening or screening visit through 5 months after the last dose of trial treatment
- Unwilling to give written, informed consent, unwilling to participate, or unable to comply with the protocol for the duration of the study
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06251973
Contacts
| Contact: Yelena Janjigian, MD | 646-888-4186 | janjigiy@mskcc.org | |
| Contact: Geoffrey Ku, MD | 646-888-4588 | kug@mskcc.org |
Locations
| United States, New Jersey | |
| Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) | Recruiting |
| Basking Ridge, New Jersey, United States, 07920 | |
| Contact: Yelena Janjigian, MD 646-888-4186 | |
| Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | Recruiting |
| Middletown, New Jersey, United States, 07748 | |
| Contact: Yelena Janjigian, MD 646-888-4186 | |
| Memorial Sloan Kettering Bergen (Limited Protocol Activities) | Recruiting |
| Montvale, New Jersey, United States, 07645 | |
| Contact: Yelena Janjigian, MD 646-888-4186 | |
| United States, New York | |
| Memorial Sloan Kettering Suffolk-Commack (Limited protocol activities) | Recruiting |
| Commack, New York, United States, 11725 | |
| Contact: Yelena Janjigian, MD 646-888-4186 | |
| Memorial Sloan Kettering Westchester (Limited Protocol Activities) | Recruiting |
| Harrison, New York, United States, 10604 | |
| Contact: Yelena Janjigian, MD 646-888-4186 | |
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Yelena Y Janjigian, MD 646-888-4186 | |
| Memorial Sloan Kettering Nassau (Limited Protocol Activities) | Recruiting |
| Uniondale, New York, United States, 11553 | |
| Contact: Yelena Janjigian, MD 646-888-4186 | |
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
| Principal Investigator: | Yelena Janjigian, MD | Memorial Sloan Kettering Cancer Center |
Additional Information:
| Responsible Party: | Memorial Sloan Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT06251973 |
| Other Study ID Numbers: |
23-361 |
| First Posted: | February 9, 2024 Key Record Dates |
| Last Update Posted: | April 5, 2024 |
| Last Verified: | April 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org. |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Memorial Sloan Kettering Cancer Center:
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Metastatic Esophageal Carcinoma Advanced Unresectable Gastric Adenocarcinoma Metastatic Gastric Cancer Metastatic Gastroesophageal Junction Adenocarcinoma Metastatic Esophageal Cancer Metastatic Esophageal Adenocarcinoma Metastatic Gastric Adenocarcinoma Metastatic Gastric Carcinoma |
Unresectable Esophageal Cancer Unresectable Esophageal Adenocarcinoma Unresectable Gastric Carcinoma Unresectable Gastric Adenocarcinoma Unresectable Gastroesophageal Junction Adenocarcinoma 23-261 Memorial Sloan Kettering Cancer Center |
Additional relevant MeSH terms:
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Carcinoma Adenocarcinoma Stomach Neoplasms Esophageal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Head and Neck Neoplasms |
Esophageal Diseases Paclitaxel Ramucirumab Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |