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ARC101 in Advanced Solid Tumors

RECRUITINGPhase 1Sponsored by Third Arc Bio
Actively Recruiting
PhasePhase 1
SponsorThird Arc Bio
Started2025-02-05
Est. completion2028-05-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations2 sites

Summary

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

Eligibility

Age: 18 Years+Healthy volunteers accepted
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.

Conditions2

Advanced Solid TumorCancer

Locations2 sites

Michigan

1 site
START Midwest
Grand Rapids, Michigan, 49546
Manish Sharma, MD

Texas

1 site
START San Antonio, LLC.
San Antonio, Texas, 78229
Kyriakos Papadopoulos, MD

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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