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RecruitingPhase 1NCT06672185

ARC101 in Advanced Solid Tumors

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Trial Parameters

ConditionAdvanced Solid Tumor
SponsorThird Arc Bio
Study TypeINTERVENTIONAL
PhasePhase 1
Enrollment70
SexALL
Min Age18 Years
Max AgeN/A
Start Date2025-02-05
Completion2028-05-01
Interventions
ARC101

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Brief Summary

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

Eligibility Criteria

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.

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