Evaluating ARC101 for advanced solid tumors
A Phase 1 Study of ARC101 in Advanced Solid Tumors
This study is testing a new treatment called ARC101 to see if it is safe and effective for people with advanced solid tumors, like ovarian and testicular cancers, that have a specific marker.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Third Arc Bio Industry-sponsored |
| Locations | 12 sites (Boston, Massachusetts and 11 other locations) |
| Trial ID | NCT06672185 on ClinicalTrials.gov |
What this trial studies
This first-in-human trial aims to assess the safety, tolerability, pharmacokinetics, and antitumor activity of ARC101 in patients with advanced solid tumors, including ovarian and testicular cancers that express Claudin 6. The study will enroll participants with measurable or evaluable disease and will monitor their response to the treatment. The trial will follow a Phase 1 design, focusing on determining the appropriate dosage and identifying any potential side effects.
Who should consider this trial
Good fit: Ideal candidates include patients with locally advanced or metastatic solid tumors that are Claudin 6 positive and have an ECOG performance status of 0-1.
Not a fit: Patients with active CNS involvement, other malignancies within the past two years, or significant pulmonary compromise may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors.
How similar studies have performed: While this approach is novel, similar studies targeting Claudin 6 in cancer have shown promise in early phases.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts and 11 other locations
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- START Midwest — Grand Rapids, Michigan, United States (Recruiting)
- START San Antonio, LLC. — San Antonio, Texas, United States (Recruiting)
- Sunshine Coast University Private Hospital — Birtinya, Queensland, Australia (Recruiting)
- Cancer Research SA — Adelaide, South Australia, Australia (Recruiting)
- Cabrini Health Research — Malvern, Victoria, Australia (Recruiting)
- BC Cancer Research Centre — Vancouver, British Columbia, Canada (Recruiting)
- The Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
- McGill University Health Centre — Montreal, Quebec, Canada (Recruiting)
- Rambam Medical Center — Haifa, Israel (Recruiting)
- Sheba Medical Center — Ramat Gan, Israel (Recruiting)
- Sourasky Medical Center — Tel Aviv, Israel (Recruiting)
Study contacts
- Study coordinator: VP Clinical Operations
- Email: clinicaltrials@thirdarcbio.com
- Phone: 267-589-9444
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.