Phase 1 Study of F182112 in Patients With Relapsed or Refractory Multiple Myeloma

Inclusion Criteria:

* 1\) Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures;

  2\) Male or female ≥ 18 years;

  3\) Patient has a history of multiple myeloma with relapsed and refractory disease, and must:
  1. Relapsed after an autologous stem cell transplant (ASCT), or not suitable for ASCT;
  2. Must have received at least 2 prior multiple myeloma treatment regimens (not including autologous stem cell transplant) including a proteasome inhibitor, an immunomodulatory agent;

     4\) ECOG of 0-2;

     5\) Patients must have measurable disease, including at least one of the criteria below:

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  1. M-protein ≥ 0.5 g/dL by SPEP/immunofixation or
  2. ≥ 200 mg/24 hours urine collection by UPEP or
  3. Serum free light chain (FLC) levels \> 100 mg/L (milligrams/liter involved light chain) and an abnormal kappa/lambda (κ/λ) ratio in patients without detectable serum or urine M-protein;

     6\) Adequate hepatic function as evidenced by meeting all the following requirements:

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  1. Blood routine: absolute neutrophil count (ANC) ≥ 1.0×109/L, hemoglobin (Hb) ≥70g/L, Platelet ≥ 50×109/L;
  2. Liver function: total bilirubin ≤ 1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 2.5 × ULN, Aspartate aminotransferase (AST) ≤ 2.5 × ULN;
  3. Renal function: calculated creatinine clearance (CrCL) ≥ 30 mL/min (Cockroft-Gault Equation).

     7\) Recovery to Grade 0-1 from adverse events related to prior anticancer therapy except alopecia, ≤ Grade 2 sensory neuropathy, lymphopenia, and endocrinopathies controlled with hormone replacement therapy.

     Exclusion Criteria:
* 1\) Patient has primary light chain amyloidosis or plasma cell leukemia;

  2\) Patient has symptomatic central nervous system involvement of multiple myeloma;

  3\) Received systemic anti-myeloma therapy within 2 weeks, or received plasma exchange within 4 weeks;

  4\) Received any experimental drugs within 4 weeks or 5 half-lives (whichever is shorter);

  5\) Patient has received ≥ 40 mg/day dexamethasone equivalent within 7 days before starting F182112. Short term use of corticosteroids at doses equivalent to \> 10 mg/d of prednisone；

  6\) Received any monoclonal antibody therapy within 30 days;

  7\) Prior treatment with any B cell maturation antigen (BCMA) targeted therapy;

  8\) Patient had a prior allogeneic stem cell transplant or had a prior autologous stem cell transplant ≤ 3 months prior to starting F182112;

  9\) Live virus vaccine within 30 days prior to study entry;

  10\) Major surgery within 4 weeks prior to study entry;

  11\) Concurrent malignancy within 3 years prior to entry other than adequately treated cervical carcinoma-in-situ, localized squamous cell cancer of the skin, basal cell carcinoma, prostate cancer under active surveillance, prostate cancer that has undergone definitive treatment, ductal carcinoma in situ of the breast, or ≤ T1 urothelial carcinoma;

  12\) Patients with active mucosa or visceral bleeding;

  13\) Severe cardiovascular disease, including CVA, TIA, myocardial infarction, or unstable angina within 6 months of study entry; NYHA class III or IV heart failure within 6 months of study entry; Uncontrolled arrhythmia within 6 months of study entry. Patients with a rate-controlled arrhythmia may be eligible for study entry at the discretion of the Medical Monitor;

  14\) Active infection requiring antibiotic, antiviral or antifungul therapy;

  15\) Active viral hepatitis;

  16\) Has a history of immunodeficiency, include HIV infection;

  17\) Treponema pallidum infection;

  18\) Received any experimental drugs or anti-tumor drugs within 2 weeks;

  19\) Subject has any condition that confounds the ability to interpret data from the study;

  20\) Females and males must practice true abstinence or agree to contraceptive methods throughout the study, and 6 months after the last giving F182112;

  21\) Any condition that the investigator or primary physician believes may not be appropriate for participating the study.