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Study of Upifitamab Rilsodotin in Combination With Carboplatin in Participants With High-grade Serous Ovarian Cancer
Trial Status: administratively complete
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 with high-grade serous ovarian cancer (HGSOC, including
fallopian tube and primary peritoneal cancer). The trial consists of dose escalation
(DES) and expansion (EXP) portion. In addition to safety assessments, the
pharmacokinetics of the drug will be assessed along with ADC activity.
Inclusion Criteria
Inclusion Criteria:
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 Criteria:
- 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).
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04907968.
Locations matching your search criteria
United States
New York
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available
Pennsylvania
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Name Not Available
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 serous ovarian cancer (HGSOC, including fallopian
tube and primary peritoneal cancer). The trial consists of dose escalation (DES) and
expansion (EXP) portion. The primary objective of the dose escalation (DES) portion is to
establish the maximum tolerated dose (MTD) for upifitamab rilsodotin in combination with
Carboplatin. In the EXP portion of the trial, participants will initiate treatment at the
MTD or recommended phase 2 dose (RP2D) determined in the DES for the combination.