Clinical Trials in Australia / NCT06672185
Recruiting
Phase 1
ARC101 in Advanced Solid Tumors
NCT06672185 · tracked via the Priya Life Science Australia tracker
Condition(s) studied
Advanced Solid Tumor
Investigational drug(s) / intervention(s)
ARC101
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
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.
Trial sites (13)
| Facility | City | Region | Status |
|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | Withdrawn |
| START Midwest | Grand Rapids | Michigan | Recruiting |
| START San Antonio, LLC. | San Antonio | Texas | Recruiting |
| Sunshine Coast University Private Hospital | Birtinya | Queensland | Recruiting |
| Cancer Research SA | Adelaide | South Australia | Recruiting |
| Cabrini Health Research | Malvern | Victoria | Recruiting |
| BC Cancer Research Centre | Vancouver | British Columbia | Recruiting |
| The Princess Margaret Cancer Centre | Toronto | Ontario | Recruiting |
| Jewish General Hospital | Montreal | Quebec | Recruiting |
| McGill University Health Centre | Montreal | Quebec | Recruiting |
| Rambam Medical Center | Haifa | Israel | Recruiting |
| Sheba Medical Center | Ramat Gan | Israel | Recruiting |
| Sourasky Medical Center | Tel Aviv | Israel | Recruiting |
Other trials for the same condition
Official registry record
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.
View NCT06672185 on ClinicalTrials.gov ↗ ← All trials in Australia