A Study of RO6927005 Either As Monotherapy (Part A) or in Combination With Gemcitabine and Nab-Pa… (NCT02317419) | Clinical Trial Compass
TerminatedPhase 1
A Study of RO6927005 Either As Monotherapy (Part A) or in Combination With Gemcitabine and Nab-Paclitaxel (Part B) to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Clinical Activity in Patients With Mesothelin-positive Metastatic and/or Locally Advanced Malignant Solid Tumors
Stopped: The study was prematurely terminated because the emerging benefit:risk ratio did not justify continuing dosing patients.
United States, Canada, Denmark15 participantsStarted 2014-12
Plain-language summary
This is a first-in-human, open-label, multi-center, Phase 1 study of RO6927005. The study will establish the safety and tolerability profile of RO6927005 and will be conducted in two parts.
In Part A, the first dose escalations will be carried out using cohorts of 1 patient. Single patient cohorts will be used to investigate increasing doses until a first dose-limiting toxicity (DLT) is reached or until grade-2 related toxicity (except infusion-related reactions), whichever comes first. At least 3 patients will be enrolled in each cohort thereafter, which, if required, can be expanded with additional patients. Part B of the study will consist of a multiple ascending dose phase (multiple patients cohorts - \>/= 3 patients) followed by an extension phase of RO6927005 given in combination with gemcitabine/nab-paclitaxel.
Preliminary clinical activity will be explored throughout the study. Patients will be treated until disease progression and/or lack of clinical benefit, unacceptable toxicities, withdrawal from treatment for other reasons, death, pregnancy or termination of the study by the Sponsor, whichever comes first.
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:
* Written informed consent
* Age \>/= 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
* Patients for whom no standard curable therapy exists
* Life expectancy of \>/= 12 weeks
* Last dose of systemic anti-neoplastic therapy \> 21 days prior to first RO6927005 infusion
* Palliative radiotherapy is allowed up to 2 weeks before the first RO6927005 infusion; palliative 8 Gy radiotherapy is allowed during therapy.
* All acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedure must have resolved to Grade \</= 1, except alopecia (any grade) and Grade 2 peripheral neuropathy
* Adequate hematological, liver, and renal function
* Negative serum or urine pregnancy test within 7 days prior to study treatment in premenopausal women and women \</= 2 years after menopause (menopause is defined as amenorrhea for \>/= 2 years)
* Agreement to use adequate contraceptive methods per protocol
* Measurable and/or evaluable disease as per the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1) \[Groups 1, 2 of Part A and Group 3 of Part B\]
Inclusion Criteria Part A: MAD
* Metastatic and/or locally advanced malignant solid tumors enriched in tumor types known to be mesothelin expressing
* Archival sample or fresh biopsy or tumor effusion must be available for retrospective mesothelin analysis
Inclusion Criteria Part A: MAD and Extension Phase (Group 1 and Group 2)
* Histologically confirmed metastatic…
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
Safety: incidence of dose-limiting toxicities, adverse events, laboratory abnormalities; incidence of anti-drug antibodies, abnormal findings on physical examination, infusion-related reactions (composite outcome measure)
Timeframe: Until disease progression, unacceptable toxicities, withdrawal for other reasons, death, or termination of the study by the Sponsor, whichever comes first, up to 2 years 8 months