A Phase 1b Study of Gemcitabine and Nab-paclitaxel in Combination With IM156 in Patients With Adv… (NCT05497778) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Phase 1b Study of Gemcitabine and Nab-paclitaxel in Combination With IM156 in Patients With Advanced Pancreatic Cancer.
United States19 participantsStarted 2022-10-21
Plain-language summary
To learn if adding a new medication, IM156, to treatment with gemcitabine and nab-paclitaxel is safe and tolerable. The ability of this combination to improve the success of this treatment for these patients will also be studied.
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:
For inclusion in the study patients must fulfill all the following criteria:
* Ability to understand and the willingness to sign a written informed consent form (ICF).
* Male or female participants ≥ 18 years of age at the time of screening. Because no dosing or adverse event data are currently available on the use of IM156 in combination with Gem + NP in patients \<18 years of age, children are excluded from this study.
* Histologically or cytologically confirmed metastatic pancreatic adenocarcinoma.
* Must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria \[13\], defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam. The measurable lesion must be outside of a radiation field if the participant received prior radiation.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 (see Appendix 1).
* Naïve to any prior treatment for metastatic disease, including chemotherapy, biological therapy, or targeted therapy.
* Prior adjuvant therapy (including chemotherapy and/or radiotherapy) for pancreatic adenocarcinoma is permitted if neoadjuvant or adjuvant therapy was completed at least 6 months prior to study enrollment. Prior adjuvant therapy may include Gem or NP.
*…
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
National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0
Timeframe: through study completion and or average of 1 year