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Recruiting Phase 1

ARC101 in Advanced Solid Tumors

NCT06672185 · tracked via the Priya Life Science Australia tracker
Sponsor
Third Arc Bio
Phase
Phase 1
Started
2025-02-05
Last updated
2026-08-27

Condition(s) studied

Advanced Solid Tumor

Investigational drug(s) / intervention(s)

ARC101

ARC101: ARC101 will be administered according to an assigned dose schedule.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Frequency and type of dose-limiting toxicities. — Day 1-Day 21 of the first treatment cycle
  • Occurrence and severity of adverse events, serious adverse events and laboratory values. — Day 1 to 100 days after the last dose of study drug.

Trial sites (13)

FacilityCityRegionStatus
Massachusetts General Hospital Boston Massachusetts Withdrawn
START Midwest Grand Rapids Michigan Recruiting
START San Antonio, LLC. San Antonio Texas Recruiting
Sunshine Coast University Private Hospital Birtinya Queensland Recruiting
Cancer Research SA Adelaide South Australia Recruiting
Cabrini Health Research Malvern Victoria Recruiting
BC Cancer Research Centre Vancouver British Columbia Recruiting
The Princess Margaret Cancer Centre Toronto Ontario Recruiting
Jewish General Hospital Montreal Quebec Recruiting
McGill University Health Centre Montreal Quebec Recruiting
Rambam Medical Center Haifa Israel Recruiting
Sheba Medical Center Ramat Gan Israel Recruiting
Sourasky Medical Center Tel Aviv Israel Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06672185 on ClinicalTrials.gov ↗ ← All trials in Australia