ARC101 for Cancer

Recruiting at 4 trial locations

Overseen By VP Clinical Operations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Third Arc Bio

Disqualifiers: CNS involvement, Uncontrolled ascites, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

70 Participants Needed

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.

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

Group I: Dose Expansion Cohorts Experimental Treatment 1 Intervention

ARC101 will be administered at recommended phase 2 dose(s).

Group II: Dose Escalation Cohorts Experimental Treatment 1 Intervention

ARC101 will be administered in escalating doses, with each dose escalation cohort assessing toxicity 21 days after the initial dose.

Who Is Running the Clinical Trial?

Third Arc Bio

Lead Sponsor

Trials

1

Recruited

70+