Study to Evaluate CCS1477 in Advanced Tumours (NCT03568656) | Clinical Trial Compass
CompletedPhase 1/2
Study to Evaluate CCS1477 in Advanced Tumours
United States, France, Netherlands220 participantsStarted 2018-07-23
Plain-language summary
A Phase 1/2a study to assess the safety, tolerability, PK and biological activity of CCS1477 in patients with metastatic castration resistant prostate cancer, metastatic breast cancer, non-small cell lung cancer or advanced solid tumours.
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:
* Provision of consent
* ECOG performance status 0-1
* Assessable disease (by CT, MRI, bone scan or X-ray)
* Adequate organ function
* Highly effective contraception measures for duration of study
Additional inclusion criteria for mCRPC patients only:
* Previously received abiraterone and/or enzalutamide (or equivalent anti-androgen), and docetaxel (unless ineligible or refused)
* Progressive disease documented by one or more of the following:
* Biochemical progression defined as at least 2 stepwise increases in a series of any 3 PSA values
* Progression as defined by RECIST v1.1 guideline for assessment of malignant soft tissue disease.
* Progression defined as two or more new metastatic bone lesions confirmed on bone scan from a previous assessment
* PSA at screening ≥2 μg/L
* Serum testosterone concentration ≤50 ng/dL
* Serum albumin \>2.5 g/dL
Additional inclusion criteria for patients in CCS1477 plus abiraterone combination arm:
* Patients must have previously progressed on abiraterone treatment
* Patients whose last dose of abiraterone is greater than 6 months prior to start of study treatment will receive a 4-week run-in treatment with abiraterone to confirm refractoriness to abiraterone treatment
Additional inclusion criteria for patients in CCS1477 plus enzalutamide combination arm:
* Patients must have previously progressed on enzalutamide treatment
* Patients whose last dose of enzalutamide is greater than 6 months prior to start o…
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.