A Phase 1/2a Study of 23ME-00610 in Patients With Advanced Solid Malignancies

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Trial ID: NCT05199272

Purpose

This is a first-in-human open-label Phase 1/2a study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of 23ME-00610 given by intravenous infusion in patients with advanced solid malignancies who have progressed on all available standard therapies

Official Title

A Phase 1/2a, Multicenter, Open-Label, Dose-Escalation and Expansion Study of Intravenously Administered 23ME-00610 in Patients With Advanced Solid Malignancies

Stanford Investigator(s)

Ali Raza Khaki, MD
Ali Raza Khaki, MD

Clinical Assistant Professor, Medicine - Oncology

Eligibility


Key Inclusion Criteria:

   1. Part A: Adults ≥ 18 years of age; Part B: ≥ 12 to years of age, weighing at least 40
   kg (total body weight)

   2. Part A: Histologically-diagnosed locally advanced (unresectable), or metastatic solid
   cancer that has progressed after all available standard therapy for the specific tumor
   type, or for which all available standard therapy has proven to be ineffective or if
   no further standard therapy exists.

   Part B:

      1. Cohort 1B: Histologically-diagnosed locally advanced (unresectable) or metastatic
      ccRCC that has progressed following all available standard therapy (e.g.,
      anti-PD(L)-1, anti-vascular endothelial growth factor [VEGF] kinase inhibitors),
      or if no further standard therapy exists.

      2. Cohort 2B: Histologically-diagnosed locally advanced (unresectable) or
      metastatic, platinum-resistant epithelial ovarian, fallopian tube or primary
      peritoneal carcinoma (i.e., disease recurrence within 6 months of completion of
      platinum-based therapy) that has progressed following all available standard
      therapy, or if no further standard therapy exists.

      3. Cohort 3B: The following histologically-diagnosed locally advanced (unresectable)
      or metastatic neuroendocrine cancers that have progressed following all available
      standard therapy, or if no further standard therapy exists:

         - Merkel cell carcinoma

         - Well-differentiated Grade 3 neuroendocrine cancers with unfavorable biology
         (as per National Comprehensive Cancer Network [NCCN] guidelines) from any
         site

         - Poorly differentiated neuroendocrine carcinoma (or extrapulmonary large and
         small cell carcinoma)

         - Patients with other cancers that show evidence of focal neuroendocrine
         differentiation may be included with approval from the medical monitor at
         23andMe.

      4. Cohort 4B: Histologically-diagnosed locally advanced (unresectable) or metastatic
      solid cancer that has progressed following all available standard therapy, or if
      no further standard therapy exists and meets the following criteria:

      TMB-H solid cancer that has been confirmed by the FoundationOne CDx assay or
      other industry/institutional equivalent platform forTMB assessment using a cutoff
      of greater than or equal to 10 mutations/megabase and/or MSI-H solid cancer that
      has been confirmed by immunohistochemistry for MMR proteins or polymerase chain
      reaction (PCR) of microsatellites or MMR gene mutation by a next-generation
      sequencing (NGS) panel.

      5. Cohort 5B: In jurisdictions where local regulations and IRB/EC allows,
      adolescents with histologically-diagnosed locally advanced (unresectable), or
      metastatic solid cancer that has progressed after all available standard
      therapies for the specific tumor type, or if no further standard therapy exists.

      6. Cohort 6B: Histologically-diagnosed locally advanced (unresectable) or metastatic
      ES-SCLC that has progressed following all available standard therapy, or if no
      further standard therapy exists.

   3. Part A: Adults 18+: Eastern Cooperative Oncology Group (ECOG) Performance Status of 0
   or 1; Part B: Adolescents ≥ 12 to < 16 years of age: Lansky Play Scale ≥ 50;
   Adolescents ≥ 16 years of age: Eastern Cooperative Oncology Group (ECOG) Performance
   Status of 0 or 1;

   4. Life expectancy ≥ 12 weeks

   5. Part A: Patients without RECIST measurable disease (e.g., evaluable disease only) will
   be eligible for enrollment in Part A, regardless of tumor type; Part B: Patients
   enrolled in Part B must have measurable disease by per RECIST 1.1 and have ≥ 1 site of
   measurable disease that has not been previously irradiated.

Key Exclusion Criteria:

   1. Females who are pregnant (positive serum pregnancy test within 7 days prior to study
   drug administration) or breastfeeding.

   2. Immune Related Medical History:

      1. Active autoimmune disease that has required systemic disease-modifying or
      immunosuppressive treatment within the last 2 years

      2. Receipt of systemic immunosuppressive therapy (e.g. steroids) within 4 weeks
      prior to the start of study drug administration

      3. History of idiopathic pulmonary fibrosis, interstitial lung disease, organizing
      pneumonia, non-infectious pneumonia that required steroids, or evidence of
      active, non-infectious pneumonitis

      4. History of Grade ≥ 3 immune-mediated toxicity

   3. Prior allogeneic or autologous bone marrow transplant, or other solid organ
   transplant.

   4. History of a positive test for:

      1. Hepatitis C virus (HCV) infection, except for those who have completed curative
      therapy for HCV and have undetectable HCV RNA

      2. Hepatitis B virus (HBV) infection, except for those who are receiving treatment
      with HBV-active nucleos(t)ide antiviral therapy at the time of study entry and
      have undetectable HBV DNA

      3. Human Immunodeficiency Virus (HIV) infection, except those who meet the following
      criteria: CD4+ T cells ≥ 350 cells/μL, no history of Acquired Immunodeficiency
      Syndrome (AIDS)-defining opportunistic infections, HIV RNA < 50 copies/mL, and on
      a stable antiretroviral regimen for at least 3 months.

   5. Prior radiation therapy with an inadequate washout between the last dose and the start
   of study drug, defined as follows: 1) at least 2 weeks for palliative radiation to the
   extremities for osseous bone metastases is required; 2) at least 4 weeks for radiation
   to the chest, brain, or visceral organs is required; and 3) at least 6 weeks for
   large-field radiation is required.

   6. Prior anticancer therapy, including chemotherapy, targeted therapy, biological therapy
   or immune-checkpoint inhibitors within 4 weeks or 5 drug half-lives (whichever is
   shorter)

   7. History of another malignancy in the previous 2 years, unless cured by surgery alone
   and continuously disease free.

   8. Recent history of cardiovascular disease

   9. Uncontrolled or symptomatic CNS (central nervous system) metastases and/or
   carcinomatous meningitis

Intervention(s):

drug: 23ME-00610

Recruiting

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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Feriel Buchholz
650-721-4090

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