Clinical trial NCT05911984: A Study to Evaluate the Safety, Tolerability, Pharmacokinetic Properties and Preliminary Efficacy of 9MW3811 in Patients With Advanced Solid Tumors
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetic Properties and Preliminary Efficacy of 9MW3811 in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced Malignant Solid Tumor
Lead sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-06-22
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single ascending dose study of 9MW3811, the primary objective of which is to evaluate the safety, tolerability and preliminary efficacy of 9MW3811 in patients with advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

1. Male or female participants between 18 and 75 years of age, inclusive.
2. Histologically or cytologically confirmed advanced malignant solid tumors, for which standard therapy does not exist or has proven ineffective or intolerable.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Life expectancy of ≥ 3 months.
5. Participants must have measurable disease according to RECIST (version 1.1).
6. Adequate organ functions.
7. Sexually active fertile participants, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy.

Exclusion Criteria:

1. Participants with cancerous meningitis and/or central nervous system metastases with clinical symptoms.
2. History of other active malignant tumor within 3 years prior to screening.
3. Suffering from poorly controlled body cavity effusion.
4. Suffering from active autoimmune disease.
5. History of chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, or other respiratory diseases that require hospitalization within 4 weeks prior to the first dose of study drug.
6. History of clinically significant cardiac or cerebrovascular diseases within 6 months prior to the first dose of study drug.
7. History of other severe or uncontrolled systemic disease, i.e. poorly controlled diabetes.
8. Previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
9. Major surgery within 28 days prior to the first dose of study drug.
10. Participants with one or more clinically significant positive test results of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, treponema pallidum antibody or human immunodeficiency virus (HIV) antibody.
11. Participants who have received treatment with biotherapy, endocrine therapy, immunotherapy, or other anti-tumor therapy within 2 weeks prior to the first dose of study drug; Radical radiotherapy received within 3 weeks or palliative radiotherapy received within 2 weeks prior to the first dose of study drug; Received treatment with chemotherapy within 3 weeks prior to the first dose of study drug (6 weeks for nitrosourea or mitomycin); Received treatment with oral fluorouracil or small molecule targeted drugs within 2 weeks or 5 half-lives prior to the first dose of study drug (whichever is shorter); Received treatment with anti-tumor traditional Chinese medicine within 1 week prior to the first dose of study drug; Participated in other clinical trials within 4 weeks prior to the first dose of study drug.
12. Participants who have received systemic treatment with immunosuppressants within 2 weeks prior to the first dose of study drug.

Primary outcomes:
measure: Incidence of adverse events (AEs) as assessed by CTCAE v5.0
timeFrame: up to 24 weeks
measure: Incidence of dose-limiting toxicity (DLT) as assessed by CTCAE v5.0
timeFrame: Cycle 1 Day 1 to Cycle 1 Day 21
Secondary outcomes:
measure: Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators
timeFrame: up to 24 weeks
measure: Disease Control Rate (DCR), According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators
timeFrame: up to 24 weeks
measure: Duration of Response (DoR), According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators
timeFrame: up to 24 weeks
measure: Progression Free Survival (PFS), According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators
timeFrame: up to 24 weeks
measure: Maximum Plasma Concentration (Cmax)
timeFrame: up to 24 weeks
measure: Time to reach Cmax (Tmax)
timeFrame: up to 24 weeks
measure: Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t)
timeFrame: up to 24 weeks
measure: Terminal elimination half-life (t1/2)
timeFrame: up to 24 weeks
measure: AUC from time 0 extrapolated to infinity (AUC0-inf)
timeFrame: up to 24 weeks
measure: Terminal elimination rate constant (λz)
timeFrame: up to 24 weeks
measure: Apparent clearance (CL)
timeFrame: up to 24 weeks
measure: Volume of distribution (Vz)
timeFrame: up to 24 weeks
measure: Incidence of antidrug antibodies (ADA) at specified timepoints relative to baseline
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References: