Clinical trial NCT05773937: A Clinical Study of 9MW2821 in Advanced Malignant Solid Tumors
Official title: A Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of 9MW2821 in Advanced Malignant Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Malignant Solid Tumors
Lead sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-03-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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, first-in-human, open-label, dose-escalation and cohort expansion study designed to characterize the safety, tolerability, pharmacokinetics, preliminary antitumor activity and immunogenicity of 9MW2821 administered by intravenous (IV) infusion.


Eligibility criteria: Inclusion Criteria:

* Competent to comprehend, sign, and date an independent ethics committee/institutional review board/research ethics board (IEC/IRB/REB) approved informed consent form.
* Male or female subjects aged 18 to 80 years (including 18 and 80 years).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Phase Ia：Histologically or cytologically confirmed advanced malignant solid tumors (except sarcoma). Phase Ib：Only local advanced or metastatic UC tumors.
* Subjects must have received ICIs or GC/GP therapies in the previous treatment.
* Subjects must submit tumor tissues for test.
* Life expectancy of ≥ 3 months.
* Subjects must have measurable disease according to RECIST (version 1.1).
* Adequate organ functions.
* 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.
* Subjects are willing to follow study procedures.

Exclusion Criteria:

* Chemotherapy、radiotherapy or immunotherpy within 14 days prior to the first dose of study drug.
* Preexisting treatment related toxicity Grade ≥ 2 (except alopecia).
* Major surgery within 28 days prior to first dose of study drug.
* History of uncontrolled diabetes mellitus.
* Preexisting peripheral neuropathy Grade ≥ 2.
* Received treatment of ADCs with MMAE payload.
* Any live vaccines within 4 weeks before first dose of study drug or during the study.
* Documented history of clinically significant cardiac or cerebrovascular diseases within 6 months prior to the first dose of study drug.
* Other severe or uncontrolled disease, i.e. severe respiratory system disease, thromboembolic events, active bleeding or active infection.
* Uncontrolled central nervous system metastases.
* History of another malignancy within 3 years before the first dose of study drug. Subjects with curable malignancies are allowed.
* History of autoimmune disease requiring systemic treatment within 2 years before the first dose of study drug.
* Has ocular conditions that may increase the risk of corneal epithelium damage.
* Known sensitivity to any of the ingredients of the investigational product; History of drug abuse or mental illness.
* Any P-glycoprotein (P-gp) inducers/inhibitors or CYP3A4 inducers/inhibitors for high and medium effect within 14 days prior to the first dose of study drug.
* Use of any investigational drug or device within 30 days prior to the first dose of study drug.
* Conditions or situations which may put the subject at significant risk.

Primary outcomes:
measure: Incidence of adverse events
timeFrame: Up to 28 days post last drug administration
Secondary outcomes:
measure: Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)
timeFrame: 24 months
measure: Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)
timeFrame: 24 months
measure: Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)
timeFrame: 24 months
measure: Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)
timeFrame: 24 months
measure: Objective Response Rate
timeFrame: Up to 24 months
measure: Disease Control Rate
timeFrame: Up to 24 months
measure: Duration of Response
timeFrame: Up to 24 months
measure: Time to Response
timeFrame: Up to 24 months
measure: Progression Free Survival
timeFrame: Up to 24 months
measure: Overall Survival
timeFrame: Up to 24 months
measure: Incidence of Anti-Drug Antibody (ADA)
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing University Cancer Hospital
state: Beijing
Study officials:
References: