NCT06672185PHASE1Recruiting
ARC101 in Advanced Solid Tumors
Third Arc Bio
Start Date
2/5/2025
Completion Date
8/1/2028
Summary
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of ARC101 in patients with advanced cancer.
Eligibility Criteria
Age Range: 18 years to No maximum
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.
Interventions
DRUG
ARC101
Conditions
Advanced Solid Tumor
Locations
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
START Midwest
Grand Rapids, Michigan 49546
United States
START San Antonio, LLC.
San Antonio, Texas 78229
United States
Sunshine Coast University Private Hospital
Birtinya, Queensland 4575
Australia
Cancer Research SA
Adelaide, South Australia 5000
Australia
Cabrini Health Research
Malvern, Victoria 3144
Australia
BC Cancer Research Centre
Vancouver, British Columbia V5Z 0B4
Canada
The Princess Margaret Cancer Centre
Toronto, Ontario M5G 2C4
Canada
McGill University Health Centre
Montreal, Quebec H4A 0B1
Canada
Rambam Medical Center
Haifa, 3109601
Israel
Sheba Medical Center
Ramat Gan, 52621
Israel
Sourasky Medical Center
Tel Aviv, 6423906
Israel