Testing a new drug for advanced solid tumors

A Phase Ⅰ/Ⅱ Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of 7MW3711 in Subjects With Advanced Solid Tumors

This study is testing a new drug for people with advanced solid tumors that haven't responded to standard treatments to see if it is safe and effective.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 281 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. (industry)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (Shanghai, 上海市)
• Trial ID: NCT06008366 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, pharmacokinetics, and efficacy of 7MW3711, an antibody-drug conjugate, in patients with advanced solid tumors. It consists of two parts: a dose escalation phase to determine the maximum tolerated dose and a dose expansion phase to further assess the drug's effects. Participants must have tumors that have progressed after standard therapies or for which no effective standard therapies exist. The study is open-label and multicenter, allowing for a diverse patient population.

Who should consider this trial

Good fit: Ideal candidates are adults with histologically confirmed advanced solid tumors that have progressed after standard treatments.

Not a fit: Patients with other malignancies within the last three years 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 solid tumors who have limited treatment choices.

How similar studies have performed: Other studies involving antibody-drug conjugates have shown promising results, indicating potential for success with this approach.

Eligibility criteria

Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
* Life expectancy of at least 3 months as assessed by the Investigator.
* Histologically or cytologically confirmed locally advanced or metastatic solid tumor, progressive after last treatment received and who progressed on or after standard therapies or intolerant to approved therapies or who lack of effient standard therapies.
* An archival tumor tissue sample(formalin-fixed paraffin-embedded (FFPE) tumor tissue block or at least 5 unstained slides) or a fresh tissue sample should be provided. If the tissue sample cannot be provided during dose escalation, enrollment into the study is allowed after discussion with the Investigator
* Measurable or evaluable disease by RECIST v1.1.
* Have adequate hematopoietic, renal and hepatic functions.
* Men or women willing to use adequate contraceptive measures throughout the study.

Exclusion Criteria:

* Have other prior malignancies within 3 years before the first administration.
* Known central nervous system metastatic disease or carcinomatous meningitis except for treated and stable brain metastases.
* Have significant, uncontrolled, or active cardiovascular disease.
* Known history of COPD, or intestinal lung disease, or other respiratory diseases requring inpatient treatments within 4 weeks prior to first administration.
* Have adverse events due to prior antitumor therapy not resolved to grade 1 or lower by NCI CTCAE V5.0.
* Have active infections requiring treatment within 14 weeks; have infection of HIV, active infection of HCV and HBV.
* Prior treatment with an antibody drug conjugate (ADC) that consists of an topoisomerase I inhibitor.
* Prior treatment with B7-H3 targeted agents.
* Have received chemotherapy, immunotherapy, curative radiation within 3 weeks prior to the first administration or targeted molecular within 2 weeks prior to first administration. have received Chinese patent medicine or Chinese herbs of anti-tumor indications within 1 weeks prior to the first administration.
* Have received any systemic immunosuppressants within 2 weeks prior to the first administration except for topical corticosteroids.
* Have received any other investigational drugs or medical device within 4 weeks prior to the first administration.
* History of drug abuse including narcotic and psychiatric drugs within 12 months prior to screening.
* Pregnant, or nursing females.

Where this trial is running

Shanghai, 上海市

• Ethics Committee of Fudan University Shanghai Cancer Center — Shanghai, 上海市, China (RECRUITING)

Study contacts

• Study coordinator: Jian Zhang, Ph.D

Conditions: Advanced Solid Tumor