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Recruiting Phase 1 NCT06672185

ARC101 in Advanced Solid Tumors

Phase 1 – testing safety in a small group of people
Conditions: Advanced Solid Tumor

Sponsor: Third Arc Bio

trial.available_in: БГ
Overview
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of ARC101 in patients with advanced cancer.
Who can participate
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.
Locations 4
Australia (1)
Sunshine Coast University Private Hospital
Birtinya , Queensland
Canada (1)
BC Cancer Research Centre
Vancouver , British Columbia
Israel (1)
Rambam Medical Center
Haifa
United States (1)
Massachusetts General Hospital
Boston , Massachusetts
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
05.02.2025
Completion date
01.08.2028
Registry ID
NCT06672185
Source
anzctr
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