ARC101 in Advanced Solid Tumors

Phase 1

Recruiting

• Conditions: Advanced Solid Tumor
• Interventions: Drug: ARC101

• Registration Number: NCT06672185
• Lead Sponsor: Third Arc Bio

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-28
• Study First Submitted QC: 2024-10-31
• Study First Posted: 2024-11-04
• Study Start: 2025-02-05
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-18
• Primary Completion: 2028-05-01
• Study Completion: 2028-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose Escalation Cohorts	ARC101	ARC101 will be administered in escalating doses, with each dose escalation cohort assessing toxicity 21 days after the initial dose.
Dose Expansion Cohorts	ARC101	ARC101 will be administered at recommended phase 2 dose(s).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
PK Assessment: Cmax of ARC101	During the intervention/study therapy administration, approximately 1 year on average.	Measurement of Maximum Observed Concentration
PK Assessment: Cmin of ARC101	During the intervention/study therapy administration, approximately 1 year on average.	Measurement of Minimum Observed Concentration
PK Assessment: Tmax of ARC101	During the intervention/study therapy administration, approximately 1 year on average.	Measurement of Time to Reach Maximum Concentration
PK Assessment: AUC of ARC101	During the intervention/study therapy administration, approximately 1 year on average.	Area under the plasma concentration versus time curve
Overall Response Rate	During 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 Response	During 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 Survival	During 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 Participants	During the intervention/study therapy administration, approximately 1 year on average.	Immunogenicity will be measured by the number of participants that are ADA positive.

Trial Locations

Locations (3)

Sunshine Coast University Private Hospital; 🇦🇺 Birtinya, Queensland, Australia

Cancer Research SA; 🇦🇺 Adelaide, South Australia, Australia

Cabrini Health Research; 🇦🇺 Malvern, Victoria, Australia