ARC101 for Cancer
Recruiting at 4 trial locations
VC
Overseen ByVP Clinical Operations
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Third Arc Bio
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
What is the purpose of this trial?
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of ARC101 in patients with advanced cancer.
Eligibility Criteria
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
My cancer can be measured or evaluated by standard criteria.
My cancer is advanced or has spread and tests positive for Claudin 6.
I am fully active or can carry out light work.
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Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Dose Escalation
ARC101 will be administered in escalating doses, with each dose escalation cohort assessing toxicity 21 days after the initial dose
21 days per cohort
Dose Expansion
ARC101 will be administered at recommended phase 2 dose(s)
Approximately 1 year
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- ARC101
Trial Overview ARC101 is the focus of this first-in-human study. It's being tested on patients with advanced cancer to see how safe it is, how the body reacts to it (pharmacokinetics), if it causes any side effects (tolerability), and whether it helps reduce tumor size or spread (antitumor activity).
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Dose Expansion CohortsExperimental Treatment1 Intervention
ARC101 will be administered at recommended phase 2 dose(s).
Group II: Dose Escalation CohortsExperimental Treatment1 Intervention
ARC101 will be administered in escalating doses, with each dose escalation cohort assessing toxicity 21 days after the initial dose.
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Who Is Running the Clinical Trial?
Third Arc Bio
Lead Sponsor
Trials
1
Recruited
70+
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