RecruitingPhase 1NCT06672185
ARC101 in Advanced Solid Tumors
A Phase 1 Study of ARC101 in Advanced Solid Tumors
Sponsor
Third Arc Bio
Enrollment
70 participants
Start Date
Feb 5, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of ARC101 in patients with advanced cancer.
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- 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 Criteria7
- 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.
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Interventions
DRUGARC101
ARC101 will be administered according to an assigned dose schedule.
Locations(12)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06672185
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