ARC101 in Advanced Solid Tumors

Third Arc Bio

Status and phase: Enrolling; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: ARC101

Study type: Interventional

Funder types: Industry

Identifiers

NCT06672185

ARC101-P1-101

Details and patient eligibility

About

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

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

70 participants in 2 patient groups

Dose Escalation Cohorts

Experimental group

Description:

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

Treatment:

Drug: ARC101

Dose Expansion Cohorts

Experimental group

Description:

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

Treatment:

Drug: ARC101