A Study of TAK-853 in Adult Participants With Folate Receptor Alpha-Positive Advanced Ovarian Can… (NCT06390995) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Study of TAK-853 in Adult Participants With Folate Receptor Alpha-Positive Advanced Ovarian Cancer And Other Solid Tumors
Japan28 participantsStarted 2024-05-20
Plain-language summary
The main aim of this study are to check for side effects from TAK-853, check how much TAK-853 participants can receive without getting side effects from it, check how well TAK-853 controls symptoms, and to check how much TAK-853 stays in their blood over time.
The study will be conducted in two phases including Phase 1 Part and Phase 2 Part. In Phase 1 Part, the participants will stay in the hospital for 3 days at least after their 1st injection for some tests and to check for any side effects from their treatment. In Phase 2 Part, participants will visit their study hospital for multiple times. In both phases, the participants will receive TAK-853 on the first days of each 3-week cycle.
The participant will be in the study for about 9 months in Phase 1 Part and for about 24 months in Phase 2 Part. The study doctors will check for side effects from the study treatments.
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
. Diagnosis, allowable prior therapy, and disease measurability requirements:
. All participants must have a pathologically documented, following advanced solid tumor known to express folate receptor alpha (FR alpha), that is resistant or refractory to standard treatment, for which no standard treatment is available, or the participant refuses standard therapy.
. All participants without prior documentation of tumor FR alpha expression by immunohistochemistry (IHC) must be willing to provide an archival tumor tissue block or slides, or undergo procedure to obtain a new biopsy using a low risk, medically routine procedure for IHC confirmation of FR alpha positivity of \>=1% of viable tumor cells with membrane staining at \>=1+ intensity for entry into Phase 1 part
. There is no upper limit on the number of prior cytotoxic or targeted therapies the participant may have received. Participants may have received prior treatment with investigational compounds targeting folate receptor excluding MIRV.
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.
1Since TAK-853 is being tested in a Phase 1/2 study and the Phase 1 part is focused on finding safe doses and tracking serious side effects, what does that mean for how much is currently known about whether this drug actually works and how risky it might be for me specifically?
2My tumor would need to test positive for folate receptor alpha to be considered for this trial — has my tumor already been tested for this marker, and if not, how would we find out?
3The trial is no longer actively enrolling new participants — does that mean it's too late for me to join, or are there any circumstances where I might still be considered?
4The study is tracking severe side effects including those that could lead to stopping the drug or reducing the dose — based on what's been reported so far, what kinds of serious adverse events have been seen most often with TAK-853?
5Given that this is still an early-phase trial for an experimental drug, would it make more sense for me to try an established standard-of-care treatment first, or are there reasons you'd recommend exploring this study at this point in my treatment?
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
Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) in Cycle 1
Timeframe: Up to Cycle 1 (up to 21 days)
2
Phase 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Timeframe: From start of study drug up to 30 days after last dose (up to 3.7 months)
3
Phase 1: Number of Participants With Grade 3 or Higher TEAEs by Severity
Timeframe: From start of study drug up to 30 days after last dose (up to 3.7 months)
4
Phase 1: Number of Participants With Serious TEAEs
Timeframe: From start of study drug up to 30 days after last dose (up to 3.7 months)
5
Phase 1: Number of Participants With TEAEs Leading to Drug Discontinuation
Timeframe: From start of study drug up to 30 days after last dose (up to 3.7 months)
6
Phase 1: Number of Participants With TEAEs Leading to Infusion Interruption
Timeframe: From start of study drug up to 30 days after last dose (up to 3.7 months)
. Participants must have measurable or non-measurable disease (such as large abdominal masses that cannot be accurately measured) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
. Participant must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
. Time from Prior Therapy:
. Participants must have stabilized or recovered (Grade 1 or baseline) from all prior therapy-related toxicities
Exclusion criteria
. Participants must have progressed radiographically on or after their most recent line of therapy
. Participants must be willing to provide an archival tumor tissue block or slides, or undergo procedure to obtain a new biopsy using a low risk, medically routine procedure for IHC confirmation of FR alpha expression (reported as "positive") as defined by the Ventana FOLR1 Assay. Tumors must be confirmed FR alpha-high as defined by FR alpha positivity of \>=75% of viable tumor cells with membrane staining at \>=2+ intensity for entry into the Phase 2.
. Participants must have at least one lesion that meets the definition of measurable disease by RECIST v1.1 criteria (radiologically measured by the Investigator).
. Participants must have received at least 1 but no more than 3 prior systemic lines of anticancer therapy, and for whom single-agent therapy is appropriate as the next line of treatment:
. Participant must have an ECOG PS of 0 or 1
. Time from prior therapy:
. Systemic antineoplastic therapy (5 half-lives or 4 weeks, whichever is shorter)
. Focal radiation completed at least 2 weeks prior to first dose of study drug
Phase 1: Number of Participants With TEAEs Leading to Dose Delayed
Timeframe: From start of study drug up to 30 days after last dose (up to 3.7 months)
8
Phase 1: Number of Participants With TEAEs Leading to Dose Reduction
Timeframe: From start of study drug up to 30 days after last dose (up to 3.7 months)
9
Phase 1: Number of Participants With Adverse Event of Clinical Interest (AECIs)
Timeframe: From start of study drug up to 30 days after last dose (up to 3.7 months)
10
Phase 2: Objective Response Rate (ORR) Assessed by Investigator With Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)