Clinical trial NCT06008366: A Phase 1/2 Study of 7MW3711 in Advanced Solid Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumor
Lead sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-08-23
Enrollment: 281
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 7MW3711 is an antibody-drug conjugate(ADC) directed to a target wildly expressed on solid tumors. This is an open-label, multicenter, phase 1/2 study to evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of 7MW3711 in subjects with advanced solid tumors.

Detailed description: Two parts are included in this study. The part of dose escalation and dose expansion(part 1) will enrolled subjects with advanced solid tumors and is to evaluate the safety and tolerability and to determine the maximum tolerated dose and/or the recommend phase 2 dose(RP2D) of 7MW3711 in subjects with advanced solid tumors.

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.

Primary outcomes:
measure: evaluation of the incidence of adverse events (AEs) (part 1)
timeFrame: approximately up to 16 cycles, 21 days a cycle
measure: Identification of the MTD and /or RP2D of 7MW3711(part 1)
timeFrame: from Day1 to Day21 in cycle1 of part 1
measure: Overall response rate (ORR) evaluated by investigators based on RECIST version 1.1 in selected solid tumors(part 2)
timeFrame: approximately up to 2 years
Secondary outcomes:
measure: overall response rate (ORR) (part1)
timeFrame: approximately up to 1 year
measure: evaluation of the incidence of adverse events (AEs) (part 2)
timeFrame: approximately up to 2 years
measure: evaluation of Peak Plasma Concentration (Cmax) of 7MW3711
timeFrame: approximately up to 2 years
measure: evaluation of AUC of 7MW3711
timeFrame: approximately up to 2 years
measure: evaluation of t1/2 of 7MW3711
timeFrame: approximately up to 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ethics Committee of Fudan University Shanghai Cancer Center
state: 上海市
Study officials:
References: