Clinical trial NCT05416749: A Clinical Study of 8MW2311 in Subjects With Locally Advanced or Metastatic Solid Tumors
Official title: Phase I/II Clinical Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Preliminary Antitumor Activity of 8MW2311 in Subjects With Locally Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
PHASE2
Conditions: Solid Tumors
Lead sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-06-13
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a Phase 1/2, first-in-human, open-label, dose-escalation and cohort expansion study designed to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, preliminary antitumor activity and immunogenicity of 8MW2311 administered by intravenous (IV) infusion.


Eligibility criteria: Inclusion Criteria:

1. Male or female, aged≥18 years old;
2. Histologically or cytologically confirmed locally advanced or metastatic solid tumor;
3. Subjects must have measurable disease according to RECIST (version 1.1)；
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;
5. Life expectancy \>3 months;
6. Adequate organ performance based on laboratory blood tests;
7. Sexually active fertile subjects, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy；
8. Ability to understand and the willingness to sign a written informed consent document；

Exclusion Criteria:

1. History of other malignancy within 3 years before the first dose of study drug.
2. History of IL-2 or IL-2 analogues anticancer therapy.
3. Chemotherapy or radiotherapy within 21 days prior to the first dose of study drug, or any other anticancer therapy within 14 days prior to the first dose of study drug.
4. Major surgery within 28 days prior to first dose of study drug.
5. Any live vaccines within 28 days before first dose of study drug or during the study.
6. Systemic glucocorticoids or other immunosuppressants received within 14 days before first dose of study drug.
7. Toxicity related to preexisting treatment ≥Grade 2.
8. Central nervous system metastasis and/or cancerous meningitis.
9. Inadequately controlled body cavity effusions.
10. Interstitial pneumonia or interstitial lung disease, other pneumonia history or active pneumonia that may interfere with the judgement of immune-related pulmonary toxicity.
11. Active autoimmune disease, or autoimmune diseases history with recurrence possibility.
12. Clinically significant cardiac or cerebrovascular disease.
13. Use of any investigational drug within 28 days prior to the first dose of study drug.
14. Known sensitivity to any of the ingredients of the study drug.
15. Known active hepatitis B or C infection, or other serious infection.
16. History of drug abuse or drug addiction.
17. Pregnancy or lactation.
18. Other disease or condition which may put the subject at significant risk.

Primary outcomes:
measure: AEs
timeFrame: Up to 28 days post last dose
measure: ORR
timeFrame: Up to 24 months
Secondary outcomes:
measure: BOR
timeFrame: Up to 24 months
measure: DCR
timeFrame: Up to 24 months
measure: CBR
timeFrame: Up to 24 months
measure: PFS
timeFrame: Up to 24 months
measure: DoR
timeFrame: Up to 24 months
measure: TTR
timeFrame: Up to 24 months
measure: TTP
timeFrame: Up to 24 months
measure: OS
timeFrame: Up to 24 months
measure: PK Parameter AUC
timeFrame: Up to 24 months
measure: PK Parameter Cmax
timeFrame: Up to 24 months
measure: PK Parameter Tmax
timeFrame: Up to 24 months
measure: PK Parameter T1/2
timeFrame: Up to 24 months
measure: Incidence of ADA
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The first affiliated hospital of bengbu medicial college
state: Anhui
city: Changsha
country: China
facility: Hunan cancer hospital
state: Hunan
city: Shanghai
country: China
facility: Jian Zhang
state: Shanghai
Study officials:
affiliation: Fudan University
name: Jian Zhang
role: PRINCIPAL_INVESTIGATOR
References: