Safety, Tolerability, and Pharmacokinetics of MW11 in Patients With Advanced Solid Tumors

NCT04478461 | Unknown Phase 1

• 1 other identifier: MW11-2019-CP101
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase Ia, single-center, open label, dose escalation clinical study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and anti-tumor efficacy of MW11 (a recombinant humanized anti-PD-1 monoclonal antibody) for injection in patients with advanced solid tumors.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Adverse Event (AE )

  safety evaluation

  2 years

• Severity Adverse Event (SAE)

  safety evaluation

  2 years

Secondary Outcomes (13)

• Elimination half life（t1/2）

  2 years

• Area under the concentration-time curve（AUC）

  2 years

• volume of distribution （Vz）

  2 years

• Plasma Clearance （CL）

  2 years

• Maximum Plasma Concentration（Cmax）

  2 years

Study Arms (1)

MW11 injection

EXPERIMENTAL

1, 3, 10 mg/kg and maybe an additional fixed dose (e.g., to evaluate 200 mg or other fixed dose as RP2D). The drug is scheduled to be administrated Q3W.

Drug: PD-1 monoclonal antibody

Interventions

PD-1 monoclonal antibody DRUG

The enrollment mainly depends on "3+3" principle. A total of 3 or 4 dose groups will be evaluated during the dose escalation period: 1, 3, 10 mg/kg, and maybe an additional fixed dose (e.g., to evaluate 200 mg or other fixed dose as RP2D). The drug is scheduled to be administrated Q3W

Also known as: MW11 injection

MW11 injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged from 18 to 75 (including 18 and 75).
• Pathological diagnosis of advanced or metastatic solid tumors.
• Advanced solid tumors that are progressed after standard antitumor therapy and can not accept or refuse to receive standard treatment.
• The ECOG score is 0 or 1.
• The subjects are expected to survive at least 3 months.
• Subjects must have at least 1 measurable lesion according to response evaluation criteria in solid tumors RECIST V1.1. The measurable lesion must be absent from the previous radiotherapy area or have progressed radiologically 4 weeks after radiotherapy.
• The subjects have proper organ and hematopoietic function, no serious heart, lung, liver, renal function abnormalities or immune deficiency according to the following laboratory tests:
• Hematology: Absolute neutrophils count (ANC) ≥ 1.5×109/L, platelet ≥ 100×109/L, hemoglobin ≥ 90g/L.
• Renal function: serum creatinine ≤ 1.5 times the upper limit of normal value (ULN) or creatinine clearance ≥ 50 mL/ min (Chockcroft-Gault formula was used for creatinine clearance).
• Liver function: AST and ALT ≤ 2.5 times ULN(AST and ALT ≤ 5 times ULN in patients with liver cancer or liver metastasis; serum total bilirubin (TBIL) ≤ 1.5 times ULN; alkaline phosphatase ≤ 1.5 times ULN(alkaline phosphatase≤ 5 times ULN in patients with liver cancer or liver metastasis, or patients with bone metastasis).
• Coagulation function: international normalized ratio (INR) ≤ 2 times ULN, or activated partial thromboplastin time (APTT) ≤ 1.5 times ULN (except for the subjects who are receiving anticoagulant therapy).
• Male subjects with fertility and female subjects of reproductive age are willing to take effective contraceptive measures from the signing of informed consent until 6 months after the last dose of drug administration. Female subjects of reproductive age (before menopause and women after menopause within 2 years) must have negative blood pregnancy test results within 7 days before the first drug administration.
• Subjects sign informed consent voluntarily, to make sure they understand the study and are willing to follow and able to complete all trial procedures.

You may not qualify if:

• Prior or current medical conditions:
• Previous history of other malignant tumors (any malignant tumor other than the tumor species treated in this study), except that the tumor has been cured for ≥ 2 years before screening and treatment is not required during the study period.
• Brain metastases.
• Prior adverse reactions failed to recover to CTCAE V5.0 grade score ≤ 1, with the exception of residual hair loss effect.
• Fluid accumulations in the body cavity (pleural effusion, ascites, pericardial effusion, etc.) that are not well controlled and require local treatment or repeated drainage.
• With active, or history of autoimmune diseases that may recur (E.G. systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis, etc.) , or high-risk patients, such as those who have received an organ transplant and require immunosuppressive therapy. But subjects with the following diseases are allowed to be enrolled:
• Subjects with type I diabetes whose condition is stable after receiving fixed dose of insulin (HgbA1C ≤ 6.5%).
• Autoimmune hypothyroidism requiring only hormone replacement therapy. Vitiligo, or skin diseases that do not require systemic treatment (such as eczema that accounts for less than 10% of the body surface, psoriasis without ophthalmic symptoms, etc.).
• Sudden onset of pulmonary disease, Interstitial lung disease or pneumonia, or other uncontrolled systemic disease including diabetes, pulmonary fibrosis, acute lung disease, cardiovascular disease including hypertension (for example, LVEF ≤50% or NYHA ≥ III) , with the exception of locally interstitial pneumonia due to radiotherapy.
• Subjects infected by human immunodeficiency virus (HIV), or with other acquired or congenital immunodeficiency diseases, or with a history of organ transplantation or stem cell transplantation.
• Subjects with active tuberculosis infection within 5 years before enrollment.
• Subjects who were seriously infected within 4 weeks prior to the first drug administration, or who had any signs or symptoms of active infection within 2 weeks priorly, or who required antibiotic treatment within 2 weeks priorly (except for the prophylactic antibiotics); or patients who had unexplained fever \>38.5℃ before the first drug administration (subject with fever caused by tumor can be enrolled according to the investigator's judgment).
• Prior medication or treatment:
• Patients who have received anti-PD-1 or PD-L1 antibody therapy or have received any other antibody/drug (such as CTLA-4) therapy targeting T-cell co-regulatory proteins (immune checkpoint) within 12 weeks prior to the first drug administration of the study.
• Subjects who have received anti-tumor therapy except:

Sponsors & Collaborators

• Mabwell (Shanghai) Bioscience Co., Ltd.: lead

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, China

RECRUITING

MeSH Terms

Interventions

spartalizumab

Study Officials

• Suxia Luo, professor

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shan An

CONTACT

13613865536; watermelonas@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 20, 2020
• Study Start: September 3, 2020
• Primary Completion: January 5, 2023
• Study Completion: February 2, 2023
• Last Updated: November 13, 2020

Record last verified: 2020-11

Locations

CN (1)