Study of 23ME-01473 in Patients With Advanced Solid Malignancies

23andMe

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Solid Tumor

Treatments: Drug: 23ME-01473

Study type: Interventional

Funder types: Industry

Identifiers

NCT06290388

23ME-01473-CLIN-001

Details and patient eligibility

About

This is a first-in-human open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of 23ME-01473 given by intravenous infusion in participants with advanced solid cancers who have progressed or are intolerant of available standard therapies.

Full description

This study includes a dose escalation portion to determine the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D) to evaluate the clinical activity of 23ME-01473 and further evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics in participants with solid malignancies.

Enrollment: 82 estimated patients

Sex: All

Ages: 18 to 110 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Phase 1: Adults ≥ 18 years of age
2. Phase 1: Histologically-diagnosed locally advanced (unresectable), or metastatic carcinoma or sarcoma that has progressed after standard therapy for the specific tumor type.
3. Adults 18+: Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
4. Life expectancy ≥ 12 weeks
5. Phase 1: Participants with evaluable disease are eligible regardless of tumor type, RECIST 1.1 can be used to assess disease progression.

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

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

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

8. Recent history (within 6 months) of serious cardiovascular disease

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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82 participants in 1 patient group

Phase 1

Experimental group

Description:

Participants will receive escalating doses of 23ME-01473

Treatment:

Drug: 23ME-01473