ARC101 in Advanced Solid Tumors

NCT ID: NCT06672185

Last Updated: 2025-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-05

Study Completion Date

2028-08-01

Brief Summary

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

Detailed Description

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Conditions

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Advanced Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Escalation Cohorts

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

Group Type EXPERIMENTAL

ARC101

Intervention Type DRUG

ARC101 will be administered according to an assigned dose schedule.

Dose Expansion Cohorts

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

Group Type EXPERIMENTAL

ARC101

Intervention Type DRUG

ARC101 will be administered according to an assigned dose schedule.

Interventions

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ARC101

ARC101 will be administered according to an assigned dose schedule.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Third Arc Bio

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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START Midwest

Grand Rapids, Michigan, United States

Site Status RECRUITING

START San Antonio, LLC.

San Antonio, Texas, United States

Site Status RECRUITING

Sunshine Coast University Private Hospital

Birtinya, Queensland, Australia

Site Status RECRUITING

Cancer Research SA

Adelaide, South Australia, Australia

Site Status RECRUITING

Cabrini Health Research

Malvern, Victoria, Australia

Site Status RECRUITING

BC Cancer Research Centre

Vancouver, British Columbia, Canada

Site Status RECRUITING

The Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status RECRUITING

Rambam Medical Center

Haifa, , Israel

Site Status RECRUITING

Sheba Medical Center

Ramat Gan, , Israel

Site Status RECRUITING

Sourasky Medical Center

Tel Aviv, , Israel

Site Status RECRUITING

Countries

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United States Australia Canada Israel

Central Contacts

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VP Clinical Operations

Role: CONTACT

267-589-9444

Other Identifiers

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ARC101-P1-101

Identifier Type: -

Identifier Source: org_study_id

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