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RecruitingLast updated: 18 September 2025

This study is recruiting people with advanced solid cancer to evaluate how safe, tolerable and effective a new immunotherapy drug (called ARC101) isA Phase 1 Study of ARC101 in Advanced Solid Tumors

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Clinical summary

Summary

This clinical trial is recruiting people with advanced solid cancer to assess a new drug called ARC101, which is a type of immunotherapy that redirects T-cells against the CLDN6 protein which can be found on the surface of cancer cells.

This study will have two parts: Dose Escalation and Dose Expansion.

During Dose Escalation, ARC101 will be administered in escalating dose levels to evaluate how safe and tolerable it is, and to determine the recommended phase 2 dose(s).

During Dose Expansion, ARC101 will be administered at the recommended phase 2 dose for further evaluation.

Conditions

This trial is treating people with locally advanced or metastatic solid cancers (ovarian, testicular or other Claudin 6+ cancers)

Eligibility

Inclusion

  • 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

  • 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.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Third Arc Bio

Scientific Title

A Phase 1 Study of ARC101 in Advanced Solid Tumors

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