Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT06672185

Recruiting

ARC101 in Advanced Solid Tumors

Interventional

Phase 1

Sponsor: Third Arc Bio

Last Updated: April 3, 2026
Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.

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

Treatment Category

Other Drugs

Required Mutations

None

Trial Started

February 5, 2025

Last Updated by Sponsor

April 3, 2026

Estimated Completion

May 1, 2028

Contact Study

Name:VP Clinical Operations

Email:clinicaltrials@thirdarcbio.com

Phone:267-589-9444

Eligibility

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.

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Design Details

AllocationNon-Randomized

Intervention ModelSequential Assignment

MaskingNone (Open Label)

Number to Enroll70

Arms & Interventions

Arms

Interventions

Type: Experimental

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

Interventions:

ARC101

Outcome Measures

Primary Outcome Measures

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.

Secondary Outcome Measures

PK Assessment: Cmax of ARC101During the intervention/study therapy administration, approximately 1 year on average.

Measurement of Maximum Observed Concentration

PK Assessment: Cmin of ARC101During the intervention/study therapy administration, approximately 1 year on average.

Measurement of Minimum Observed Concentration

PK Assessment: Tmax of ARC101During the intervention/study therapy administration, approximately 1 year on average.

Measurement of Time to Reach Maximum Concentration

PK Assessment: AUC of ARC101During the intervention/study therapy administration, approximately 1 year on average.

Area under the plasma concentration versus time curve

Overall Response RateDuring the intervention/study therapy administration, approximately 1 year on average.

Percentage of participants with best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1 and overall survival (OS)

Duration of ResponseDuring the intervention/study therapy administration, approximately 1 year on average.

Time from first objective response to disease progression per RECIST 1.1 or death to any cause

Progression-Free SurvivalDuring the intervention/study therapy administration, approximately 1 year on average.

PFS is defined as the time from the start of the treatment until objective disease progression per PFS is defined as the time from the start of the treatment until objective disease progression per RECIST 1.1 or death from any cause

Number of anti-drug antibody (ADA) Positive ParticipantsDuring the intervention/study therapy administration, approximately 1 year on average.

Immunogenicity will be measured by the number of participants that are ADA positive.