NCT06672185 · Third Arc Bio
ARC101 in Advanced Solid Tumors
What this study is about
This first-in-human study will evaluate the safety, tolerability, how the drug moves through the body, and antitumor activity of ARC101 in patients with advanced cancer.
View original scientific description
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of ARC101 in patients with advanced cancer.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Boston, Massachusetts
- Grand Rapids, Michigan
- San Antonio, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 3, 2026 · Source of record for eligibility and locations