A Phase 1/2 Study of 7MW3711 in Advanced Solid Tumors

NCT06008366 | Unknown Phase 1

• 1 other identifier: 7MW3711-2023-CP101
• Study Type: interventional
• Target: 281
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (3)

• 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)

  MTD(maximum tolerated dose) and /or RP2D(recommended phase II dose)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 complete response (CR) or partial response (PR)

  approximately up to 2 years

Secondary Outcomes (5)

• overall response rate (ORR) (part1)

  approximately up to 1 year

• evaluation of the incidence of adverse events (AEs) (part 2)

  approximately up to 2 years

• evaluation of Peak Plasma Concentration (Cmax) of 7MW3711

  approximately up to 2 years

• evaluation of AUC of 7MW3711

  approximately up to 2 years

• evaluation of t1/2 of 7MW3711

  approximately up to 2 years

Study Arms (2)

Dose escalation and dose expansion

EXPERIMENTAL

All subjects enrolled in the part of dose escalation and dose expansion will receive 7MW3711 by introvenous infusion

Drug: 7MW3711 for injection

Cohort expansion

EXPERIMENTAL

All subjects enrolled in the part of cohort expansion will be treated by 7MW3711 will receive 7MW3711 by introvenous infusion

Drug: 7MW3711 for injection

Interventions

7MW3711 for injection DRUG

IV administration of 7MW3711, Q3W, 3 weeks a cycle

Dose escalation and dose expansion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Ethics Committee of Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Jian Zhang, Ph.D

CONTACT

18017312991; syner2000@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 23, 2023
• Study Start: September 5, 2023
• Primary Completion: August 30, 2025
• Study Completion: February 1, 2026
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

CN (1)