RightFit
RecruitingPhase 1

Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma

A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb819 in Subjects With Relapsed or Refractory Clear Cell Renal Cell Carcinoma

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of XmAb®819, given into a vein or under the skin, and aims to find a safe dose that works in the body. It focuses on advanced clear cell kidney cancer that has come back or resisted treatment, but the entry rules also list other kidney, lung, and colon or rectal cancers.

The purpose of this study is to assess the safety and tolerability of XmAb®819 administered intravenous (IV) or subcutaneous (SC) in subjects with relapsed or refractory clear cell renal cell carcinoma and to identify the minimum safe and biologically active dose and the recommended dose (RD).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a tumor that can be measured. A tumor in an area treated with radiation must have grown since that treatment.
  • Have clear cell or papillary kidney cancer, non-small cell lung cancer, or colon or rectal cancer that has come back, resisted treatment, and worsened on standard care.
  • Be fully active or able to do light work despite some limits on hard physical activity.
  • Have enough stored tumor tissue available for testing.

Who can't join

  • Have had an experimental treatment targeting ENPP3, also called CD203c.
  • Have had a serious allergic reaction to monoclonal antibody treatment, a type of protein-based medicine.
  • Have received cancer medicine that acts throughout the body too recently. The required wait depends on how long that medicine stays in the body.
  • Still have serious side effects from earlier cancer treatment.
  • Have active cancer spread to the brain or spinal cord, or their lining. Previously treated brain tumors may be allowed if scans show they are stable.
  • Have an active disease in which the immune system attacks the body. Exceptions include vitiligo, type 1 diabetes, certain thyroid problems treated only with hormones, skin conditions treated without whole-body medicine, and arthritis needing no whole-body medicine beyond acetaminophen or anti-inflammatory pain medicines.
  • Have had a serious infection needing medicine through a vein within 14 days before the first study dose.
  • Have another cancer that is growing or has needed active treatment in the past 2 years.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Subjects must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the local site investigator. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. * Subjects who have relapsed and refractory ccRCC, pRCC, NSCLC, and CRC with evidence of disease progression on standard-of-care therapies * ECOG performance status of 0 or 1. * All subjects must have adequate tumor sample available (slides or archival FFPE blocks) Exclusion Criteria: * Prior treatment with an investigational anti-ENPP3/CD203c therapy * History of serious allergic or anaphylactic/hypersensitivity reaction to monoclonal antibody therapy * Systemic antineoplastic therapy within 5 half-lives on the first dose of study treatment. * Failure to recover from any clinically significant toxicity related to previous anticancer treatment * Have known active central nervous system metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable, * Active known autoimmune disease (except that subjects are permitted to enroll if they have vitiligo; type 1 diabetes mellitus; residual hypothyroidism due to an autoimmune condition that is treatable with hormone replacement therapy only; psoriasis, atopic dermatitis, or another autoimmune skin condition that is managed without systemic therapy; or arthritis that is managed without systemic therapy beyond oral acetaminophen and nonsteroidal anti-inflammatory drugs) * Evidence of any serious infection requiring IV anti-infective treatment within 14 days prior to the first dose of study drug * Have a known additional malignancy that is progressing or has required active treatment within the past 2 years

Study sites (20)

AZ

CA

CT

FL

GA

IL

KY

MN

NC

NJ

NY

OH

OK

TN

WA