ARC101 for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, ARC101, to determine its safety and effectiveness for people with advanced cancer. The study explores different doses to identify the optimal one and monitor for side effects. People with specific solid tumors, such as ovarian or testicular cancer, may qualify if their cancer has spread. Participants must have good organ function and be physically capable of daily activities. The goal is to assess ARC101’s potential in fighting cancer. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in humans.
Do I need to stop taking my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that ARC101 is likely to be safe for humans?
Research has shown that ARC101 is undergoing its first human trials to test safety. This treatment is a new type of drug called a bispecific antibody, designed to target cancer cells. In these early trials, the primary goal is to assess how well participants tolerate the treatment and to determine the appropriate dose.
As a Phase 1 trial, there is limited data on ARC101's safety in humans. However, early phases focus on evaluating safety and understanding how the body processes the treatment. Prior to this, in non-human tests, ARC101 demonstrated strong effects against cancer cells in the lab. While promising, human studies are necessary to confirm its safety.
Participants in the trial will receive varying doses of ARC101 to observe their body's reactions. This process helps researchers identify any side effects and establish the optimal dose for future studies. As an early-stage trial, it is designed to closely monitor safety and treatment tolerance.12345Why do researchers think this study treatment might be promising?
Researchers are excited about ARC101 for cancer because it works differently than existing treatments. Most standard treatments, like chemotherapy and radiation, aim to kill cancer cells directly but can also harm healthy cells. ARC101, however, is being tested for its potential to target cancer cells more precisely with its new mechanism of action, which could result in fewer side effects. Additionally, the dose escalation approach allows researchers to fine-tune the optimal dose, potentially improving effectiveness and safety. This innovative approach could represent a significant advancement in cancer treatment.
What evidence suggests that ARC101 might be an effective treatment for cancer?
Research has shown that ARC101 could be a promising cancer treatment by targeting tumors with a specific protein called CLDN6, found in some cancers. In lab studies, ARC101 effectively killed cancer cells even at low doses, suggesting it might be a strong option for treating certain tumors. This treatment is a bispecific antibody, meaning it can attach to two targets, helping the body's immune system attack cancer cells. In this trial, researchers will administer ARC101 in different cohorts, including dose escalation to assess toxicity and dose expansion at recommended phase 2 doses. Although human studies have provided limited information, these early results are encouraging for its potential to treat advanced cancers.12356
Are You a Good Fit for This Trial?
This trial is for adults with advanced solid tumors, specifically ovarian, testicular or other cancers positive for Claudin 6. Participants must have a condition that can be measured by medical imaging and should be relatively active and able to care for themselves (ECOG status 0-1). They also need to have their major organs functioning well.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
ARC101 will be administered in escalating doses, with each dose escalation cohort assessing toxicity 21 days after the initial dose
Dose Expansion
ARC101 will be administered at recommended phase 2 dose(s)
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ARC101
Find a Clinic Near You
Who Is Running the Clinical Trial?
Third Arc Bio
Lead Sponsor