A Study of 7MW3711 in Subjects 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

7MW3711 is a antibody-drug conjugate(ADC) drected 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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: 7MW3711 for injection; Drug: 7MW3711 for injection

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 pahse 2 dose(RP2D) of 7MW3711 in subjects with advanced solid tumors.

The part of cohort expansion(part 2) will enrolled subejcts with selected advanced solid tumors and is to assess the preliminary efficacy of 7MW3711 in selected advanced solid tumors.

• Study Type: Interventional
• Enrollment (Estimated): 164
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Sun Lu, Doctor; Phone Number: 021-22200000*3121; Email: shun-lu@hotmail.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China
      • Not yet recruiting
      • Henan Cancer Hospital
      • Contact: qiming Wang
  • Hunan
    • Changsha, Hunan, China
      • Not yet recruiting
      • Hunan Cancer Hospital
      • Contact: Yongzhong Luo
  • Jiangsu
    • Xuzhou, Jiangsu, China, 221009
      • Not yet recruiting
      • Xuzhou Central Hospital
      • Contact: Liang Han
  • Shanghai
    • Shanghai, Shanghai, China, 2000043
      • Recruiting
      • The Lung Cancer Center of Shanghai Chest Hospital
      • Contact: Sun Lu, Doctor; Phone Number: 021-22200000*3121; Email: shun-lu@hotmail.com
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Not yet recruiting
      • Zhejiang Cancer Hospital
      • Contact: Zhengbo Song, Doctor; Email: songzb@zjcc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dose escalation and dose expansion; all subjects enrolled in the part of dose escalation and dose expansion will receive 7MW3711 by introvenous infusion	Drug: 7MW3711 for injection; IV administration of 7MW3711, Q3W, 3 weeks a cycle; Drug: 7MW3711 for injection; IV administration of 7MW3711, the dosage regimen including dosage and dosing frequency for cohort expansion is conformed on basis of the data in part 1
Experimental: cohort expansion; all subjects enrolled in the part of cohort expansion will be treated by 7MW3711 will receive 7MW3711 by introvenous infusion	Drug: 7MW3711 for injection; IV administration of 7MW3711, Q3W, 3 weeks a cycle; Drug: 7MW3711 for injection; IV administration of 7MW3711, the dosage regimen including dosage and dosing frequency for cohort expansion is conformed on basis of the data in part 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluation of the incidence of adverse events (AEs) (part 1)	Incidence and seriousness of adverse events (AEs) and serious adverse events (SAEs) by CTCAE version 5.0.	approximately up to 16 cycles, 21 days a cycle
Identification of the MTD and /or RP2D of 7MW3711(part 1)		from Day1 to Day21 in cycle1 of part 1
Overall response rate (ORR) evaluated by investigators based on RECIST version 1.1 in selected solid tumors. (part 2)	ORR:defined as the proportion of patients who achieved a best overall response of completeresponse (CR) or partial response (PR)	approximately up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluation of PK parameters of 7MW3711	Maximum observed concentration(Cmax)	approximately up to 2 years
evaluation of PK parameters of 7MW3711	the time to Cmax(tmax)	approximately up to 2 years
evaluation of PK parameters of 7MW3711	half-live(t1/2)	approximately up to 2 years
evaluation of PK parameters of 7MW3711	Area under the concentration-time curve(AUC)	approximately up to 2 years
overall response rate (ORR) (part1)	ORR:defined as the proportion of patients who achieved a best overall response of completeresponse (CR) or partial response (PR) based on RECIST version 1.1.	approximately up to 1 years
disease control rate(DCR)	DCR:defined as the proportion of subjects with CR, PR, and SD based on RECIST 1.1 criteria	approximately up to 2 years
progression-free survival(PFS)	PFS:defined as time from the date of first administration to the date of first documented disease progression based on RECIST 1.1 criteria, or death due to any cause, whichever occurs first	approximately up to 2 years
time to response (TTR)	TTR:defined as time from the date of first administration to the date of first documented CR or PR	approximately up to 2 years
evaluation of the immunogenicity of 7MW3711	Frequency and percentage of subjects with positive anti-drug antibody after being treated by 7MW3711.	approximately up to 2 years
evaluation of the incidence of adverse events (AEs) (part 2)	Incidence and seriousness of adverse events (AEs) and serious adverse events (SAEs) by CTCAE version 5.0.	approximately up to 2 years

Collaborators and Investigators

• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2023
• Primary Completion (Estimated): August 30, 2025
• Study Completion (Estimated): January 30, 2026

Study Registration Dates

• First Submitted: August 7, 2023
• First Submitted That Met QC Criteria: August 18, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 7MW3711-2023-CP102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No