Recruiting
Phase 1

ARC101

Sponsor:

Third Arc Bio

Code:

NCT06672185

Conditions

Advanced Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ARC101

Study Details

Brief summary:

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

Conditions

Advanced Solid Tumor

Study ID

NCT06672185

Start date

Feb 5, 2025

Status verified date

Aug, 2026

Completion date

Aug 1, 2028

Anticipated

Primary completion date

May 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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.

Study Design

Enrollment

70 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation Cohorts

ARC101 will be administered in escalating doses, with each dose escalation cohort assessing toxicity 21 days after the initial dose.

experimental: Dose Expansion Cohorts

ARC101 will be administered at recommended phase 2 dose(s).

Interventions

ARC101

ARC101 will be administered according to an assigned dose schedule.

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

VP Clinical Operations

267-589-9444clinicaltrials@thirdarcbio.com

Locations

START Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

Principal Investigator:

Manish Sharma, MD

START San Antonio, LLC.

Recruiting

San Antonio, Texas, United States, 78229

Principal Investigator:

Kyriakos Papadopoulos, MD

BC Cancer Research Centre

Recruiting

Vancouver, British Columbia, Canada, V5Z 0B4

Principal Investigator:

Christian Kollmannsberger, MD

The Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Principal Investigator:

Stéphanie Lheureux, MD, PhD

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Principal Investigator:

Susie Lau, MD

McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H4A 0B1

Principal Investigator:

Lucy Gilbert, MD

More Information

Sponsor

Third Arc Bio

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Third Arc Bio on 2026-08-27.