A Phase I/IIa, Multicenter, Open-label, Dose Escalation and Expansion Study of Intravenously Administered 23ME-01473 in Participants With Advanced Solid Malignancies
Considering participating in a START clinical trial?
Study Summary
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.
To determine the safety and tolerability of ‘1473 in people with locally advanced or metastatic solid malignancies that have progressed after standard therapy. This study will also evaluate the pharmacokinetic and pharmacodynamic profile of ‘1473 to identify the optimal dose and schedule for further clinical studies
The safety and preliminary anti-tumor activity of 23ME-01473 are being evaluated in a Phase 1/2a dose escalation and expansion study in adults with locally advanced unresectable or metastatic solid malignancies that have progressed on standard therapies with ECOG 0-1; adolescents 12 years of age or older will be included in the expansion phase.
- 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.
- 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
Clinical Study Information for Healthcare Providers
By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.