A Phase I, First in Human Study of CTIM-76, a Claudin-6 (CLDN6)-Directed Bispecific Antibody, in Patients With Recurring Ovarian Cancer and Other Advanced Tumors
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Study Summary
To evaluate the safety and efficacy of CTIM-76 (study drug), a CLDN6-directed T cell-engaging bispecific antibody, in participants with platinum-refractory/resistant ovarian cancer (PRROC) and other advanced CLDN6-positive solid tumors (i.e., testicular and endometrial). The dose escalation and dose expansion portions of the trial are expected to evaluate safety, tolerability, and pharmacokinetics as well as anti-tumor activity by overall response rate, duration of response, and disease control rate.
To evaluate the safety and efficacy of CTIM-76 in subjects with CLDN6-positive advanced or metastatic ovarian, endometrial and testicular cancers.
The dose escalation and dose expansion portions of the trial are expected to evaluate safety, tolerability and pharmacokinetics, as well as anti-tumor activity by overall response rate, duration of response and disease control rate.
- * Participants with CLDN6 positive platinum resistant/refractory ovarian, advanced testicular or advanced endometrial cancer. * Participants with measurable disease per RECIST 1.1. * ECOG 0, 1, or 2 and life expectancy of ≥ 12 weeks. Participants with adequate organ function.
- Key Eligibility Inclusion Criteria • Patients with platinum-resistant recurrent epithelial (non-mucinous) ovarian cancer who had disease progression on or after standard of care, including 21 line of platinum / taxane, and if eligible, prior treatment with bevacizumab • Patients with endometrial cancer who had disease progression on or after treatment with at least 1 platinum-containing or immunotherapy-based regimen for advanced, recurrent disease • Patients with testicular germ cell cancer with 22 prior lines of treatment, Including platinum-based chemotherapy and either salvage or high dose chemotherapy with autologous stem cell transplant • Patients with ovarian and endometrial cancer must have histologically or cytologically confirmed CLDN6-positive tumors defined as CLDN6 expression in 2 10% of the tumor cells (2 +1 intensity) by IHC. Patients with testicular cancer are exempt from IHC screening based on known high prevalence of CLDN6 expression • ECOC Performance Status 0-2 • Measurable disease per RECIST VI .1 • Prior toxicity resolved to Grade Sl (CTCAE v5.O) except alopecia, G2 peripheral neuropathy • Adequate organ function (per standard laboratory parameters further defined in the study protocol)
- * Evidence of central nervous system metastases, leptomeningeal disease or spinal cord compression. * Uncontrolled significant active infection or any medical or other condition that in opinion of the Investigator would preclude the participant's participation in the study. Concurrent participation in another investigational clinical trial. Evidence of central nervous system metastases, leptomeningeal disease, or spinal cord compression Not eligible if persistent irAEs from prior immune therapies. Prior history of severe AES such as carditis, pneumonitis, encephalitis, hepatitis, or colitis with prior immune therapies will be excluded Autoimmune disorders requiring chronic systemic therapy or any other form of immunosuppressive therapy while on the study. Recent or current use of inhaled steroids, physiological substitution in case of adrenal insufficiency, or local or topical use is not exclusionary No prior treatment with CLDN6-targeted therapies Cardiovascular disease, e.g., stroke or myocardial infarction withing 6 months of first dose of study drug, New York Heart Association class 3 or 4 congestive heart failure, unstable angina pectoris, serious cardiac arrythmias, etc. Uncontrolled significant active infection or any medical or other condition that may increase the risk associated with the study participation
Clinical Study Information for Healthcare Providers
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