RecruitingInterventionalPhase 1

A Phase 1 Study of ARC101 in Advanced Solid Tumors

NCT ID: NCT06672185Sponsor: Third Arc BioLast updated: 2026-04-03

Summary

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

Arms & interventions

DrugARC101
ARC101 will be administered according to an assigned dose schedule.

Outcome measures

Primary

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

Secondary

PK Assessment: Cmax of ARC101
Time frame: During the intervention/study therapy administration, approximately 1 year on average.
PK Assessment: Cmin of ARC101
Time frame: During the intervention/study therapy administration, approximately 1 year on average.
PK Assessment: Tmax of ARC101
Time frame: During the intervention/study therapy administration, approximately 1 year on average.
PK Assessment: AUC of ARC101
Time frame: During the intervention/study therapy administration, approximately 1 year on average.
Overall Response Rate
Time frame: During the intervention/study therapy administration, approximately 1 year on average.
Duration of Response
Time frame: During the intervention/study therapy administration, approximately 1 year on average.
Progression-Free Survival
Time frame: During the intervention/study therapy administration, approximately 1 year on average.
Number of anti-drug antibody (ADA) Positive Participants
Time frame: During the intervention/study therapy administration, approximately 1 year on average.

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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.

Study locations (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114

Recruiting

Oladapo Yeku, MD · Principal Investigator

START Midwest

Grand Rapids, Michigan, 49546

Recruiting

Manish Sharma, MD · Principal Investigator

START San Antonio, LLC.

San Antonio, Texas, 78229

Recruiting

Kyriakos Papadopoulos, MD · Principal Investigator