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Recruiting NCT07265622

First-in-human Study of 7MW4911 in Patients With Advanced Solid Tumors

Phase I / Phase II Interventional Solid Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 7MW4911.
Who it may be relevant to
Registry conditions: Solid Tumors. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of 7MW4911 in Patients With Advanced Solid Tumors

Overview

This is the first-in-human study of 7MW4911 in Chinese patients, to investigate its prelimary safety and efficacy in patients with Advanced Solid Tumors.

Interventions

  • Drug 7MW4911
    7MW4911 for IV infusion of various dose strengths administered

Primary outcome measures

  • Incidence and rates of adverse events [Time frame: Up to approximately 2 years]
  • Maximum tolerated dose (MTD), recommended expansion dose (RED) and the recommended phase II dose (RP2D) [Time frame: Up to approximately 2 years]
Secondary outcome measures (7)
  • Objective response rate [Time frame: Up to approximately 2 years]
  • Progression-free survival [Time frame: Up to approximately 2 years]
  • Immunogenicity [Time frame: Up to approximately 2 years]
  • Tmax [Time frame: Up to 3 months]
  • Cmax [Time frame: Up to 3 months]
  • t1/2 [Time frame: Up to 3 months]
  • Area under the curve [Time frame: Up to 3 months]

Eligibility criteria

Inclusion criteria

  • Aged 18\~75.
  • ECOG 0-1.
  • Life expectancy ≥ 3 months.
  • Participants with pathologically (histologically or cytologically) confirmed advanced solid tumors.
  • Disease progression after the most recent treatment regimen.
  • At least one measurable lesion according to RECIST v1.1.
  • Provision of archival tumor tissue or fresh biopsy.
  • Adequte hematologic funciton, liver function and renal function.
  • Comply with contraceptive requirements.

Exclusion criteria

  • Other concurrent malignancy in the recent 3 years except for adequately treated carcinoma in situ.
  • Active, untreated or symptomatic CNS metastasis.
  • Effusions that require frequent drainage.
  • Patients with active autoimmune disease, except for type I diabetes, hypothyroidism and other autoimmune disease that does not require systemic treatment.
  • Severe respiratory disease that required hospitalization in the last 28 days.
  • Significant and uncontrolled cardiovascular disease or events in the 6 months prior to study drug administration.
  • Poorly controlled blood glucose with fasting blood glucose above 10 mmol/L.
  • Recipient of allogeneic stem cell transplant or organ transplant
  • Active HIV or hepatitis B/C infection. Infection requiring systemic IV in the 14 days prior to study drug administration.
  • Experiencing toxicities from prior anti-cancer therapies that have not recovered to CTCAE grade 0-1, except for alopecia and endocrinopathies.
  • Prohibited treatment and treatment that requires washout period: (1) Has received another Topo-I payload ADC, and/or another CDH17 targeting therapy. (2) Received other cancer therapy within 5 half-lives or 21 days prior to study drug administration. (3) Major surgeries within 28 days prior to study drug administration. (4) Investigational therapy within 28 days prior to study drug administration. (5) Systemic treatment with immunosuppressive agents within 28 days prior to first drug administration. Physiological dose of glucocorticoid, topical glucocorticoid are allowed. (6) Use of strong CYP3A4 inhibitor or inducer.
  • Known hypersensitivity to 7MW4911 or components of the formulation.
  • Abuse of narcotic or psychoactive drugs.
  • Pregnant or breastfeeding women.
  • Other circumstances or conditions where the investigator judges to be unsuitable for study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Fudan University Shanghai Cancer Center — Shanghai

Identifiers

NCT: NCT07265622 · 7MW4911-CP102

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗