A Phase I Study of ARC101 in Advanced Solid Tumors

Study Identifier:
ARC101-P1-101
CT.gov Identifier:
NCT06672185
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
N/A
Recruiting

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Study Summary

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

To evaluate the optimal dosing, safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary antitumor efficacy of ARC101 as monotherapy in patients with locally advanced or metastatic solid tumors expressing CLDN6.

To determine the optimal dosing, safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor efficacy of ARC101 as monotherapy in patients with locally advanced or metastatic CLDN6 expressing solid tumors.

Part 1 is designed to select the Maximum Tolerated Dose (MTD), Recommended-Phase 2-Dose (RP2D) and dosing schedule of ARC101

Part 2 will further explore the safety, PK/PD characteristics, and preliminary efficacy of ARC101 administered at the RP2D and schedule identified in Part 1 in patients with testicular and ovarian cancer.

Patients must have received standard therapy for advanced or metastatic disease, and disease must be measurable per Response Criteria in Solid Tumors (RECIST) v1.1 or evaluable. Mandatory requirement of a pre-study tumour sample for IHC analysis will facilitate the exploratory objective of biomarker analysis, including correlating CLDN6 expression with treatment response.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Dose Escalation Cohorts
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  • Drug: Experimental: Dose Expansion Cohorts
  • Drug: Intervention/Treatment
  • Drug: ASCO 2025:
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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
    • Key eligibility criteria include patients with any advanced or refractory solid tumor malignancy that expresses CLDN6 and is metastatic or unresectable. Patients must be ≥18 years of age.
    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.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Kyriakos Papadopoulos
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Manish Sharma
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor