ARC101 in Advanced Solid Tumors

Last updated: April 16, 2025
Sponsor: Third Arc Bio
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

ARC101

Clinical Study ID

NCT06672185
ARC101-P1-101
  • Ages > 18
  • All Genders

Study 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

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

Exclusion Criteria:

  • Active CNS involvement

  • Malignancy diagnosis other than the disease under study within 2 years prior to thefirst dose of study drug.

  • Presence of uncontrolled ascites

  • Toxicity related to prior anticancer therapy that has not returned to Grade ≤1 orbaseline 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 ormale participant who plans to father a child either while enrolled or within 90 daysafter the final administration of study drug.

Study Design

Total Participants: 70
Treatment Group(s): 1
Primary Treatment: ARC101
Phase: 1
Study Start date:
February 05, 2025
Estimated Completion Date:
August 01, 2028

Connect with a study center

  • Sunshine Coast University Private Hospital

    Birtinya, Queensland 4575
    Australia

    Active - Recruiting

  • Cancer Research SA

    Adelaide, South Australia 5000
    Australia

    Active - Recruiting

  • Cabrini Health Research

    Malvern, Victoria 3144
    Australia

    Active - Recruiting

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