ARC101 in Advanced Solid Tumors

Recruiting now · Phase 1

Conditions studied: Advanced Solid Tumor

In brief

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of ARC101 in patients with advanced cancer.

Key facts

Study ID

NCT06672185

Run by

Third Arc Bio

People needed

70

Starts

2025-02-05

Expected to finish

2028-08-01

Last updated by the study team

2026-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• START Midwest — Grand Rapids, Michigan, United States (enrolling)
• START San Antonio, LLC. — San Antonio, Texas, United States (enrolling)
• Sunshine Coast University Private Hospital — Birtinya, Queensland, Australia (enrolling)
• Cancer Research SA — Adelaide, South Australia, Australia (enrolling)
• Cabrini Health Research — Malvern, Victoria, Australia (enrolling)
• BC Cancer Research Centre — Vancouver, British Columbia, Canada (enrolling)
• The Princess Margaret Cancer Centre — Toronto, Ontario, Canada (enrolling)
• McGill University Health Centre — Montreal, Quebec, Canada (enrolling)
• Rambam Medical Center — Haifa, Israel (enrolling)
• Sheba Medical Center — Ramat Gan, Israel (enrolling)
• Sourasky Medical Center — Tel Aviv, Israel (enrolling)

Full record on ClinicalTrials.gov

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