Testing 9MW2821 for advanced malignant solid tumors

A Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of 9MW2821 in Advanced Malignant Solid Tumors

This study is testing a new treatment called 9MW2821 to see if it is safe and effective for people with advanced solid tumors.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. (industry)
• Drugs / interventions: Chemotherapy
• Locations: 2 sites (Beijing, Beijing Municipality and 1 other locations)
• Trial ID: NCT05773937 on ClinicalTrials.gov

What this trial studies

This Phase 1 clinical study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of 9MW2821 in patients with advanced malignant solid tumors. It involves a dose-escalation and cohort expansion approach, where participants will receive the treatment via intravenous infusion. The study aims to gather data on the immunogenicity of the drug and its effects on tumor progression.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with confirmed advanced malignant solid tumors who have previously received immune checkpoint inhibitors or specific chemotherapy regimens.

Not a fit: Patients with sarcomas or those who do not meet the eligibility criteria, such as having inadequate organ function or a life expectancy of less than three months, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced malignant solid tumors.

How similar studies have performed: While this approach is novel in its specific application, similar studies involving immunotherapy for solid tumors have shown promising results.

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.

Where this trial is running

Beijing, Beijing Municipality and 1 other locations

• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (RECRUITING)
• Beijing University Cancer Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Conditions: Advanced Malignant Solid Tumors