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NCT Number: NCT06672185

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.

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Key information

Conditions

Advanced Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sunshine Coast University Private Hospital, Birtinya, Queensland, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ARC101

Drug

ARC101 will be administered according to an assigned dose schedule.

Primary outcomes

  1. Frequency and type of dose-limiting toxicities.

    Time frame: Day 1-Day 21 of the first treatment cycle

  2. Occurrence and severity of adverse events, serious adverse events and laboratory values.

    Time frame: Day 1 to 100 days after the last dose of study drug.

Secondary outcomes

  1. PK Assessment: Cmax of ARC101

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

    Measurement of Maximum Observed Concentration

  2. PK Assessment: Cmin of ARC101

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

    Measurement of Minimum Observed Concentration

  3. PK Assessment: Tmax of ARC101

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

    Measurement of Time to Reach Maximum Concentration

  4. PK Assessment: AUC of ARC101

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

    Area under the plasma concentration versus time curve

  5. Overall Response Rate

    Time frame: 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)

  6. Duration of Response

    Time frame: 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

  7. Progression-Free Survival

    Time frame: 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

  8. Number of anti-drug antibody (ADA) Positive Participants

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

    Immunogenicity will be measured by the number of participants that are ADA positive.

Study contacts

Contact information is provided by the study sponsor or research team.

VP Clinical Operations

CONTACT

[email protected]

267-589-9444

Sponsors and collaborators

Lead sponsor

Third Arc Bio

Industry

Registry information

Official study title

A Phase 1 Study of ARC101 in Advanced Solid Tumors

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 4, 2024
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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