A Study of M701 (EpCAM and CD3) in Malignant Ascites

Y

YZY Biopharma

Status and phase

Unknown
Phase 1

Conditions

Cancer
Malignant Ascites

Treatments

Drug: Cohort 1 of M701
Drug: Cohort 3 of M701
Drug: Cohort 7 of M701
Drug: Cohort 5 of M701
Drug: Cohort 2 of M701
Drug: Cohort 4 of M701
Drug: Cohort 6 of M701

Study type

Interventional

Funder types

Industry

Identifiers

NCT04501744
M70102

Details and patient eligibility

About

This study is to investigate the safety, tolerability, PK, PD and immunogenicity of multiple ascending doses of M701 administered intraperitoneally to patients with malignant ascites caused by advanced solid tumors.

Full description

To evaluate the safety and tolerability of multiple ascending doses of M701 administered intraperitoneally in patients with malignant ascites.

Enrollment

42 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Males or females, aged > 18 years;
  • Histologically- or cytologically-confirmed advanced solid tumors;
  • Patients who require therapeutic paracentesis, defined as at least 1 therapeutic paracentesis (e.g., to relieve abdominal pressure and discomfort) during 4 weeks prior to the baseline paracentesis;
  • Patients who have failed to standard treatment, or who have no standard treatment available that may confer clinical benefit;
  • EpCAM+ tumor cells in ascites fluid;
  • Patients who have received anti-tumor therapy including chemotherapy, hormone therapy, radiotherapy (except local radiotherapy for pain relief) ≥ 2 weeks or received immunotherapy, biological agents ≥ 3 weeks prior to the first dose of study drug;
  • Patients who have recovered from any toxic reaction to previous medications (Grade 0 or 1 based on NCI-CTCAE v5.0);
  • Patients with an ECOG Performance Status score (PS) 0-3;
  • Patients with a life expectancy > 8 weeks;

Organ function levels must meet the following requirements:

Bone marrow: absolute neutrophil count (ANC) ≥ 1.5 ×10^9/L, platelet count ≥ 80 ×10^9/L, hemoglobin ≥ 9.0 g/dL (without blood transfusion within14 days of the first dose of study drug); Liver: bilirubin ≤ 1.5 x upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤ 3 x ULN ( ≤ 5 x ULN in case of liver metastases); Kidney: serum creatinine ≤1.5 x ULN and estimated glomerular filtration rate (eGFR) ≥ 50 ml/min;

Patients must understand and voluntarily sign the informed consent form.

Exclusion criteria

  • Known to have a history of allergy to the active ingredients of M701; or with a definite history of drug allergy or specific allergy (asthma, rubella, eczema dermatitis);
  • Known or suspected hypersensitivity to M701 or similar antibodies;
  • Extensive liver metastases (> 70% organ volume comprises malignancy);
  • Uncontrolled active infection (CTCAE ≥ Grade 2);
  • Serious diarrhea (CTCAE ≥ Grade 2);
  • Serious dyspnea requiring oxygen therapy;
  • History of auto-immune diseases (e.g. inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, serious psoriasis, rheumatoid arthritis);
  • History of acute or chronic pancreatitis;
  • Other serious diseases that may prevent patients participation in this trial (such as uncontrolled diabetes mellitus, severe gastrointestinal disorders);
  • Cardiac insufficiency, NYHA class III or IV;
  • Intestinal obstruction that occurred within 30 days prior to the first dose of study drug;
  • Non-drainable ascites;
  • Confirmed portal vein obstruction;
  • History of immunodeficiency, including positive HIV test;
  • Active hepatitis B virus infection or hepatitis C virus infection, positive syphilis antibody test and positive HIV antibody test;
  • Pregnant or breastfeeding woman;
  • Plan to conceive within six months;
  • Previous confirmed history of neurological or mental disorders, including epilepsy and dementia;
  • Have received a clinical study active drug treatment within 1 month prior to the first dose of study drug;
  • Those that are deemed ineligible for this clinical trial by study personnel.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

42 participants in 1 patient group

M701
Experimental group
Description:
Patients will undergo a 2-week screening period and a 4-week core treatment period, and eligible patients who complete the core treatment period will receive a cycle of extended treatment (once weekly for 4 weeks) until disease progression or toxicity intolerance.
Treatment:
Drug: Cohort 6 of M701
Drug: Cohort 4 of M701
Drug: Cohort 2 of M701
Drug: Cohort 5 of M701
Drug: Cohort 7 of M701
Drug: Cohort 3 of M701
Drug: Cohort 1 of M701

Trial contacts and locations

0

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Central trial contact

Xiong Wang

Data sourced from clinicaltrials.gov

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