Evaluating 7MW3711 for patients with advanced solid tumors

A Phase 1/2 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 called 7MW3711 to see if it is safe and effective for people with advanced solid tumors.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 164 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 5 sites (Zhengzhou, Henan and 4 other locations)
• Trial ID: NCT06008379 on ClinicalTrials.gov

What this trial studies

This study investigates the safety, tolerability, pharmacokinetics, and efficacy of 7MW3711, an antibody-drug conjugate, in patients with advanced solid tumors. It consists of two parts: the first part focuses on dose escalation to determine the maximum tolerated dose, while the second part involves cohort expansion to assess the preliminary efficacy of the drug in selected tumor types. The study is open-label and multicenter, allowing for a diverse patient population.

Who should consider this trial

Good fit: Ideal candidates include individuals with advanced solid tumors who have progressed after standard treatments or are intolerant to them.

Not a fit: Patients with early-stage tumors or those who have not received any prior systemic therapy 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 that have not responded to standard therapies.

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.
* Part 1: 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; part 2: Histologically or cytologically confirmed locally advanced or metastatic selected advanced solid tumors having progressed after at least one line of standard systermic therapy or intolerate 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

Zhengzhou, Henan and 4 other locations

• Henan Cancer Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
• Hunan Cancer Hospital — Changsha, Hunan, China (Not_yet_recruiting)
• Xuzhou Central Hospital — Xuzhou, Jiangsu, China (Not_yet_recruiting)
• The Lung Cancer Center of Shanghai Chest Hospital — Shanghai, Shanghai, China (Recruiting)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Sun Lu, Doctor

Conditions Advanced Solid Tumor