ARC101: ARC101 will be administered according to an assigned dose schedule.
Study summary
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of ARC101 in patients with advanced cancer.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Locally advanced or metastatic solid tumor ovarian, testicular or other Claudin 6+ cancers
* Measurable or evaluable disease, per RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Adequate organ function
Exclusion Criteria:
* Active CNS involvement
* Malignancy diagnosis other than the disease under study within 2 years prior to the first dose of study drug.
* Presence of uncontrolled ascites
* Toxicity related to prior anticancer therapy that has not returned to Grade ≤1 or baseline levels
* Clinically significant pulmonary compromise
* Active autoimmune disease within 12 months prior to first dose of study drug.
* Female participant who is pregnant, breastfeeding, or plans to become pregnant or male participant who plans to father a child either while enrolled or within 90 days after the final administration of study drug.
Primary outcome measure(s)
Frequency and type of dose-limiting toxicities. — Day 1-Day 21 of the first treatment cycle
Occurrence and severity of adverse events, serious adverse events and laboratory values. — Day 1 to 100 days after the last dose of study drug.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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