NCT06672185

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P75+ for phase_1

Timeline
26mo left

Started Feb 2025

Typical duration for phase_1

Geographic Reach
4 countries

10 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress37%
Feb 2025Aug 2028

First Submitted

Initial submission to the registry

October 28, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 4, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

February 5, 2025

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

October 24, 2025

Status Verified

October 1, 2025

Enrollment Period

3.2 years

First QC Date

October 28, 2024

Last Update Submit

October 22, 2025

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • PK Assessment: Cmax of ARC101

    During the intervention/study therapy administration, approximately 1 year on average.

  • PK Assessment: Cmin of ARC101

    During the intervention/study therapy administration, approximately 1 year on average.

  • PK Assessment: Tmax of ARC101

    During the intervention/study therapy administration, approximately 1 year on average.

  • PK Assessment: AUC of ARC101

    During the intervention/study therapy administration, approximately 1 year on average.

  • Overall Response Rate

    During the intervention/study therapy administration, approximately 1 year on average.

  • +3 more secondary outcomes

Study Arms (2)

Dose Escalation Cohorts

EXPERIMENTAL

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

Drug: ARC101

Dose Expansion Cohorts

EXPERIMENTAL

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

Drug: ARC101

Interventions

ARC101DRUG

ARC101 will be administered according to an assigned dose schedule.

Dose Escalation CohortsDose Expansion Cohorts

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

START Midwest

Grand Rapids, Michigan, 49546, United States

RECRUITING

START San Antonio, LLC.

San Antonio, Texas, 78229, United States

RECRUITING

Sunshine Coast University Private Hospital

Birtinya, Queensland, 4575, Australia

RECRUITING

Cancer Research SA

Adelaide, South Australia, 5000, Australia

RECRUITING

Cabrini Health Research

Malvern, Victoria, 3144, Australia

RECRUITING

BC Cancer Research Centre

Vancouver, British Columbia, V5Z 0B4, Canada

RECRUITING

The Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

Rambam Medical Center

Haifa, 3109601, Israel

RECRUITING

Sheba Medical Center

Ramat Gan, 52621, Israel

RECRUITING

Sourasky Medical Center

Tel Aviv, 6423906, Israel

RECRUITING

Central Study Contacts

VP Clinical Operations

CONTACT

267-589-9444clinicaltrials@thirdarcbio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2024

First Posted

November 4, 2024

Study Start

February 5, 2025

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

October 24, 2025

Record last verified: 2025-10

Locations

US(2)AU(3)CA(2)IL(3)