A Study to Evaluate the Safety and Pharmacokinetics of OC-001 in Patients With Locally Advanced o… (NCT04260802) | Clinical Trial Compass
TerminatedPhase 1/2
A Study to Evaluate the Safety and Pharmacokinetics of OC-001 in Patients With Locally Advanced or Metastatic Cancers
Stopped: Business Decision
Canada73 participantsStarted 2020-09-24
Plain-language summary
This study will investigate OC-001 as monotherapy, and in combination with, Avelumab, in various cancer types
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
. Have the presence of evaluable disease for the Phase 1b Monotherapy
. Have the presence of evaluable and measurable disease for the Phase 1b combination part and the Phase 2a part of the study.
. The patient must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have failed to provide clinical benefit for their disease or patients who have refused standard treatments.
Exclusion criteria
. Have symptomatic central nervous system (CNS) metastasis. Patients with treated CNS metastases are eligible for this study if they are asymptomatic and off of corticosteroids for a minimum of 7 days. Patients with primary brain tumors are not eligible
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
Number of participants with a Dose Limiting Toxicity (DLT) in Phase 1b
Timeframe: Baseline through Cycle 1 (Day 28)
2
Number of participants with any Serious Adverse Event or Treatment-Emergent Adverse Event in Phase 2a
. Have a history of major organ transplant (e.g., heart, lungs, liver, and kidney) or an autologous or allogeneic hematopoietic stem cell transplant
. Females who are pregnant or nursing
. Have known, symptomatic acquired immuno deficiency syndrome (AIDS) or active hepatitis A, B or C
. Previous treatment-related, severe (≥Grade 3) Adverse Event (AE) or any neurologic or ocular AE while receiving an IO agent
. Active or prior documented autoimmune disease within the past 2 years Patients with vitiligo, Grave's disease or psoriasis not requiring systemic treatment within the past 2 years are eligible
. Active or prior documented inflammatory bowel disease
. History of tuberculosis, interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required corticosteroid therapy