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Purpose

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of ARC101 in patients with advanced cancer.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dose Escalation Cohorts 		ARC101 will be administered in escalating doses, with each dose escalation cohort assessing toxicity 21 days after the initial dose.
  • Drug: ARC101
    ARC101 will be administered according to an assigned dose schedule.
Experimental
Dose Expansion Cohorts 		ARC101 will be administered at recommended phase 2 dose(s).
  • Drug: ARC101
    ARC101 will be administered according to an assigned dose schedule.

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114

START Midwest
Grand Rapids, Michigan 49546

START San Antonio, LLC.
San Antonio, Texas 78229

More Details

Status
Recruiting
Sponsor
Third Arc Bio

Study Contact

VP Clinical Operations
267-589-9444
clinicaltrials@thirdarcbio.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.