Status:
TERMINATED
Study of Upifitamab Rilsodotin in Combination With Carboplatin in Participants With High-grade Serous Ovarian Cancer
Lead Sponsor:
Mersana Therapeutics
Collaborating Sponsors:
IQVIA Biotech
PSI CRO
Conditions:
Platinum-sensitive Ovarian Cancer (UPGRADE-A)
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
Phase 1 safety study of the antibody-drug conjugate (ADC) XMT-1536 (upifitamab rilsodotin) administered as an intravenous infusion once every four weeks in combination with Carboplatin in participants...
Detailed Description
This trial is an open-label, multi-center Phase 1 study of upifitamab rilsodotin administered as an intravenous infusion once every 28 days in combination with Carboplatinin patients with high-grade s...
Eligibility Criteria
Inclusion
- Participant must be at least 18 years of age, and female; Participant must be able to understand the study procedures and agree to participate in the study by providing informed consent
- Participants must have a histological diagnosis of metastatic or recurrent high-grade serous ovarian cancer, which includes fallopian tube, or primary peritoneal cancer.
- Participant has received 1 to 3 prior lines of therapy for their ovarian cancer; a non-platinum-based chemotherapy regimen is permitted provided it is not the most recent line of therapy. Participant must have platinum-sensitive recurrent disease
- Participant must have an ECOG performance status 0 or 1
- Participant must have measurable disease as per RECIST v1.1
- Tumor sample must be provided, either an archival tumor tissue block or slides or, if not available, a tumor tissue block or slides from a new tumor biopsy obtained through a low-risk, medically routine procedure.
- Participants with toxicity from prior therapy or surgical procedures must have recovered to ≤ Grade 1. Participants with alopecia, stable immune-related toxicity such as hypothyroidism on hormone replacement, or adrenal insufficiency treated with ≤10 mg daily prednisone (or equivalent), after prior taxane therapy are exceptions to this criterion and may qualify for this study.
- Participants must have cardiac left ventricular ejection fraction (LVEF) ≥50% or ≥ the institution's lower limit of normal as measured by either Echo or MUGA scan
- Participants must have adequate organ function within 14 days prior to enrollment
- A female participant is eligible to participate if she is not pregnant or breastfeeding, if she is not a woman of childbearing potential (WOCBP), or if she is a WOCBP potential and using a contraceptive method that is highly effective.
Exclusion
- Participant has known sensitivity to any of the study medications, or components thereof, or a history of drug or allergy that contraindicates their participation
- Participant is unable or unlikely to comply with dosing schedule and study evaluations.
- Participant has a prior hypersensitivity reaction to carboplatin requiring desensitization or discontinuation.
- Participant has prior platelet or neutrophil toxicity to carboplatin-containing therapy requiring dose reduction to AUC \<5 mg x mL/min in the most recent regimen containing carboplatin
- Known history of CTCAE version 5.0 Grade 4 thrombocytopenia OR history of bleeding in association with any grade thrombocytopenia
- Participant has had major surgery within 28 days of starting study treatment, systemic anticancer therapy within the lesser of 28 days or 5 half-lives of the prior therapy before starting study treatment (14 days or 5 half-lives for small molecule targeted therapy), or recent radiation therapy with unresolved toxicity or within a time window of potential toxicity
- Participant has received prior treatment with mirvetuximab soravtansine or another ADC containing an auristatin or maytansinoid payload.
- Participant has untreated CNS metastases (including new and progressive brain metastases), history of leptomeningeal metastasis, or carcinomatous meningitis.
- Has a diagnosis of additional malignancy that required treatment within 2 years prior to screening, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix
- Participant is unwilling to be transfused with blood components.
- Participant is receiving concurrent anti-cancer therapy (e.g. chemotherapy, radiation therapy, biologic therapy, immunotherapy, hormonal therapy, investigational therapy).
Key Trial Info
Start Date :
June 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 3 2023
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04907968
Start Date
June 11 2021
End Date
October 3 2023
Last Update
October 10 2023
Active Locations (1)
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1
START Midwest
Grand Rapids, Michigan, United States, 49546