A Study of NTX-1088, a Monoclonal Antibody Targeting the Poliovirus Receptor (PVR, CD155), as Mon… (NCT05378425) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study of NTX-1088, a Monoclonal Antibody Targeting the Poliovirus Receptor (PVR, CD155), as Monotherapy and Combined With Pembrolizumab
United States, Israel, Poland90 participantsStarted 2022-09-01
Plain-language summary
This is a Phase 1,open-label, multi-center, first-in-human, 2-part (Part 1: dose escalation and Part 2: expansion) study, evaluating multiple doses and schedules of intravenously (IV) administered NTX-1088, with or without pembrolizumab, in patients with advanced solid malignancies (i.e., locally advanced or metastatic).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The patient must have histologic or cytologic evidence of an advanced (locally advanced or metastatic) malignant solid cancer known to express PVR, including colorectal carcinoma (MSI-H and MSS with no liver mets), hepatocellular carcinoma, gastric/gastroesophageal junction/esophageal carcinoma, Non-Small Cell Lung Cancer (NSCLC), endometrial carcinoma, cervical carcinoma, Squamous Cell Carcinoma of the Head and Neck (SCCHN), Renal Cell Carcinoma (RCC), cutaneous melanoma, Basal Cell Carcinoma (BCC) or another tumor type approved by the Medical Monitor.
. Except for dose escalation with pembrolizumab for patients in whom mAbs targeting PD-1 as monotherapy are the standard of care, patients enrolled in the dose-escalation parts must have disease that is resistant to or relapsed following available standard systemic therapy, or for which there is no standard systemic therapy or reasonable therapy in the physician's judgment likely to result in clinical benefit, or if such therapy has been refused by the patient. Documentation of the reason must be provided for patients who have not received a standard therapy likely to result in clinical benefit.
. Patient must have received no more than 4 prior systemic therapies. Special cases of \>4 prior systemic therapies will be discussed between the investigator and the Sponsor's medical team.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. A fresh tumor biopsy will be required if the biopsy procedure is not a significant risk procedure defined as one without mortality or major morbidity in the patient's clinical setting and at the institution completing the procedure is estimated to be ≥2%. The Medical Monitor must be contacted to review documentation of biopsy risk.
. Patients enrolled in the dose-escalation part at relevant NTX-1088 doses (i.e., NTX-1088 at a dose \>400 mg) will be required to undergo a tumor biopsy during the screening period and at the end of Cycle 2 (±7 days from C3D1), if the procedure is not a significant risk procedure as defined above.
. Patients enrolled in the expansion part will be required to undergo a tumor biopsy during the screening period and at the end of Cycle 2 (±7 days from C3D1), if the procedure is not a significant risk procedure as defined above.
. The patient must have disease that is measurable by RECIST, version 1.1 (APPENDIX A) as assessed by the local site Investigator/radiology. For patients with prior radiation therapy, measurable lesions must be outside of any prior radiation field(s), unless disease progression has been documented at that site after radiation.
. The patient is ≥18 years old on the day of signing the consent form.
Exclusion criteria
. The patient (for combination arm only) was discontinued from treatment with an immuno-oncology therapeutic due to a Grade 3 or higher immune-related adverse event (irAE) except endocrine disorders that can be treated with replacement therapy or was discontinued from that treatment due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis. This does not apply to irAEs due to prior treatment with cell therapy.
. The patient has received prior radiotherapy within 2 weeks of treatment. Patients must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation with a limited port ≤2 weeks of radiotherapy to non-central nervous system (CNS) disease.
. The patient has received radiation therapy to the lung that is \>30 Gy within 6 months of the first dose of study medication.
. The patient has received treatment with approved anticancer therapies including cytotoxic chemotherapy, monoclonal antibodies, and/or small molecule tyrosine kinase inhibitors within 14 days prior to study therapy administration or 5 half-lives, whichever is shorter (42 days for nitrosourea or mitomycin-C); patients with advanced prostate cancer who are receiving luteinizing hormone releasing hormone (LHRH) agonists are permitted onto the study and should continue use of these agents during study treatment.
. The patient has had an allogeneic tissue/solid organ transplant.
. The patient has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention.
. The patient has received prior treatment with another investigational agent that targets PVR.
. If the patient had major surgery, the patient must have recovered adequately from the procedure and/or any complications from the surgery prior to starting study intervention.