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Recruiting NCT06672185

ARC101 in Advanced Solid Tumors

Phase I Interventional Advanced Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ARC101.
Who it may be relevant to
Registry conditions: Advanced Solid Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Canada, Israel
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1 Study of ARC101 in Advanced Solid Tumors

Overview

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

Interventions

  • Drug ARC101
    ARC101 will be administered according to an assigned dose schedule.

Primary outcome measures

  • Frequency and type of dose-limiting toxicities. [Time frame: Day 1-Day 21 of the first treatment cycle]
  • 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 outcome measures (8)
  • PK Assessment: Cmax of ARC101 [Time frame: During the intervention/study therapy administration, approximately 1 year on average.]
  • PK Assessment: Cmin of ARC101 [Time frame: During the intervention/study therapy administration, approximately 1 year on average.]
  • PK Assessment: Tmax of ARC101 [Time frame: During the intervention/study therapy administration, approximately 1 year on average.]
  • PK Assessment: AUC of ARC101 [Time frame: During the intervention/study therapy administration, approximately 1 year on average.]
  • Overall Response Rate [Time frame: During the intervention/study therapy administration, approximately 1 year on average.]
  • Duration of Response [Time frame: During the intervention/study therapy administration, approximately 1 year on average.]
  • Progression-Free Survival [Time frame: During the intervention/study therapy administration, approximately 1 year on average.]
  • Number of anti-drug antibody (ADA) Positive Participants [Time frame: During the intervention/study therapy administration, approximately 1 year on average.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 3 centers
  • Massachusetts General Hospital — Boston
  • START Midwest — Grand Rapids
  • START San Antonio, LLC. — San Antonio
Australia · 3 centers
  • Sunshine Coast University Private Hospital — Birtinya
  • Cancer Research SA — Adelaide
  • Cabrini Health Research — Malvern
Canada · 3 centers
  • BC Cancer Research Centre — Vancouver
  • The Princess Margaret Cancer Centre — Toronto
  • McGill University Health Centre — Montreal
Israel · 3 centers
  • Rambam Medical Center — Haifa
  • Sheba Medical Center — Ramat Gan
  • Sourasky Medical Center — Tel Aviv

Identifiers

NCT: NCT06672185 · ARC101-P1-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗