Naptumomab Estafenatox in Combination With Durvalumab in Subjects With Selected Advanced or Metas… (NCT03983954) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Naptumomab Estafenatox in Combination With Durvalumab in Subjects With Selected Advanced or Metastatic Solid Tumor, Including a Cohort Expansion in Esophageal Cancer.
India, Israel120 participantsStarted 2019-10-10
Plain-language summary
This Phase 1b is a dose escalation, MTD expansion and cohort expansions study to assess the safety and tolerability of a combination of NAP with durvalumab in subjects with selected advanced or metastatic solid tumors.
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.
Subjects must meet all of the following criteria to participate in this study:
1. Adult at least 18 years of age
2. For the Dose-escalation and MTD Expansion Cohorts: Histologically and/or cytologically confirmed solid tumor from the following list, that is metastatic/advanced, and for which no curative therapy exists:
1. Pancreatic adenocarcinoma
2. High-grade serous ovarian cancer
3. Cervical squamous cell carcinoma
4. Prostate cancer
5. ER+/HER2- or triple-negative breast cancer
6. NSCLC including driver mutation positive.
7. Mesothelioma
8. Renal cell carcinoma
9. Bladder/urothelial cancer
10. Head and neck squamous cell carcinoma
11. Melanoma
12. Hepatocellular carcinoma
13. Endometrial cancer
14. MTD Expansion Cohort only: 5T4-positive colorectal cancer and 5T4 positive GE cancer
3. For the Esophageal Expansion Cohort: Subjects must have histologically confirmed locally advanced or metastatic ESCC or AC of the esophagus or GEJ (Siewert type 1).
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
5. All patients must provide signed informed consent prior to any study specific procedures that are not part of standard medical care.
6. In the MTD Expansion Cohort only, an archival or fresh biopsy will be acceptable at baseline. A second biopsy on Cycle 2 Day 4 is optional for patients who provided a fresh biopsy at baseline or have a tumor sample available from up to 3 months prior to study entry. Patients e…
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.
What they're measuring
1
Part A: Dose Escalation / MTD Expansion: The incidence and characteristics of adverse events, associated with ascending doses of NAP in combination with a set dose of durvalumab
Timeframe: From day 1 up to 90 days following last dose of study drug
2
Part A: Dose Escalation / MTD Expansion: The incidence and characteristics of adverse events, associated with ascending doses of NAP in combination with a set dose of durvalumab and following pretreatment with obinutuzumab.
Timeframe: From day -13 up to 90 days following last dose of study drug
3
Part A: Dose Escalation / MTD Expansion: The RP2D either with or without obinutuzumab pretreatment
Timeframe: From day -13 up to 90 days following last dose of study drug