ARC101 in Advanced Solid Tumors
Purpose
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of ARC101 in patients with advanced cancer.
Condition
- Advanced Solid Tumor
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
| Arm | Description | Assigned 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. |
|
|
Experimental Dose Expansion Cohorts |
ARC101 will be administered at recommended phase 2 dose(s). |
|
Recruiting Locations
Massachusetts General Hospital
Boston, Massachusetts 02114
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- Third Arc Bio