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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

Interested in This Trial?

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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