ARC101 in Advanced Solid Tumors

A Phase 1 Study of ARC101 in Advanced Solid Tumors

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

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: ARC101

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: VP Clinical Operations; Phone Number: 267-589-9444; Email: clinicaltrials@thirdarcbio.com

Study Locations

• Australia
  • Queensland
    • Birtinya, Queensland, Australia, 4575
      • Recruiting
      • Sunshine Coast University Private Hospital
      • Principal Investigator: Michelle Morris
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Recruiting
      • Cancer Research SA
      • Principal Investigator: Meena Okera
  • Victoria
    • Malvern, Victoria, Australia, 3144
      • Recruiting
      • Cabrini Health Research
      • Principal Investigator: Prachi Bhave
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 0B4
      • Recruiting
      • BC Cancer Research Centre
      • Principal Investigator: Christian Kollmannsberger, MD
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • Recruiting
      • The Princess Margaret Cancer Centre
      • Principal Investigator: Stéphanie Lheureux, MD, PhD
  • Quebec
    • Montreal, Quebec, Canada, H4A 0B1
      • Recruiting
      • McGill University Health Centre
      • Principal Investigator: Lucy Gilbert, MD
• Israel
  • Haifa, Israel, 3109601
    • Recruiting
    • Rambam Medical Center
    • Principal Investigator: Ruth Perets, MD, PhD
  • Ramat Gan, Israel, 52621
    • Recruiting
    • Sheba Medical Center
    • Principal Investigator: Ronnie Shapira, MD
  • Tel Aviv, Israel, 6423906
    • Recruiting
    • Sourasky Medical Center
    • Principal Investigator: Ravit Geva, MD
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Principal Investigator: Oladapo Yeku, MD
  • Michigan
    • Grand Rapids, Michigan, United States, 49546
      • Recruiting
      • START Midwest
      • Principal Investigator: Manish Sharma, MD
  • Texas
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • START San Antonio, LLC.
      • Principal Investigator: Kyriakos Papadopoulos, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Escalation Cohorts; ARC101 will be administered in escalating doses, with each dose escalation cohort assessing toxicity 21 days after the initial dose.	Drug: ARC101; ARC101 will be administered according to an assigned dose schedule.
Experimental: Dose Expansion Cohorts; ARC101 will be administered at recommended phase 2 dose(s).	Drug: ARC101; ARC101 will be administered according to an assigned dose schedule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
PK Assessment: Cmax of ARC101	Measurement of Maximum Observed Concentration	During the intervention/study therapy administration, approximately 1 year on average.
PK Assessment: Cmin of ARC101	Measurement of Minimum Observed Concentration	During the intervention/study therapy administration, approximately 1 year on average.
PK Assessment: Tmax of ARC101	Measurement of Time to Reach Maximum Concentration	During the intervention/study therapy administration, approximately 1 year on average.
PK Assessment: AUC of ARC101	Area under the plasma concentration versus time curve	During the intervention/study therapy administration, approximately 1 year on average.
Overall Response Rate	Percentage of participants with best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1 and overall survival (OS)	During the intervention/study therapy administration, approximately 1 year on average.
Duration of Response	Time from first objective response to disease progression per RECIST 1.1 or death to any cause	During the intervention/study therapy administration, approximately 1 year on average.
Progression-Free Survival	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	During the intervention/study therapy administration, approximately 1 year on average.
Number of anti-drug antibody (ADA) Positive Participants	Immunogenicity will be measured by the number of participants that are ADA positive.	During the intervention/study therapy administration, approximately 1 year on average.

Collaborators and Investigators

• Sponsor: Third Arc Bio

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: October 28, 2024
• First Submitted That Met QC Criteria: October 31, 2024
• First Posted (Actual): November 4, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: ARC101-P1-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No