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NCT Number: NCT06947226

A Clinical Study of 9MW2821 Monotherapy or Combined With Other Anticancer Therapy in Advanced Solid Tumors

This study is a Phase Ib/ll, open-label, multicenter study designed to evaluate the safety and efficacy of 9MW2821 monotherapy or combined with other anticancer therapy in advanced solid tumors.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 451161, China

Location contact

Feng Wang

CONTACT

[email protected]

13938244776

Feng Wang

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Competent to comprehend, sign, and date an independent ethics committee/institutional review board/research ethics board (IEC/IRB/REB) approved informed consent form.
  • Male or female subjects aged 18 to 75 years (including 18 and 75 years).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Histopathological diagnosed of recurrent or locally advanced or metastatic solid tumors.
  • Adequate tumor tissues submitted for test.
  • Life expectancy of ≥ 12 weeks.
  • Subjects must have measurable disease according to RECIST (version 1.1).
  • Adequate organ functions.
  • Sexually active fertile subjects, and their partners, must agree to use contraception during the study and at least 6 months after termination of study therapy.
  • Subjects are willing to follow study procedures.

Exclusion criteria

  • History of another malignancy within 3 years before the first dose of study drug.
  • Ongoing clinically significant toxicities related to prior treatment.
  • Grade ≥ 2 peripheral neuropathy.
  • Severe or uncontrolled gastrointestinal diseases.
  • Other severe or uncontrolled diseases, including severe respiratory diseases, cardiovascular and cerebrovascular diseases of clinical significance.
  • Experienced clinically significant bleeding or had a clear bleeding tendency.
  • Central nervous system (CNS) metastasis and/or malignant meningitis.
  • Clinically significant pleural, abdominal, or pericardial effusion.
  • Chemotherapy or radiotherapy within 21 days prior to the first dose of study drug;
  • Known sensitivity to any of the ingredients of the investigational product; History of drug abuse or mental illness.
  • Pregnant and lactating women.
  • Other conditions that, in the Investigator's opinion, may not be suitable for the subject to be enrolled.

Treatment and study plan

9MW2821

Drug

Subjects will receive intravenous (IV) infusion of 9MW2821 as per protocol

Other anti-cancer therapy

Drug

Subjects will receive other anticancer therapy as per protocol

Primary outcomes

  1. Incidence of AE/SAE (phase Ib)

    Time frame: Up to approximately 24 months

    Adverse event (AE), serious adverse event (SAE)

  2. Objective Response Rate, ORR (phase II)

    Time frame: Up to approximately 24 months

    The proportion of participants with complete response (CR) or partial response (PR)

Secondary outcomes

  1. Duration of Response, DOR

    Time frame: Up to approximately 24 months

    Time from the date of the first CR or PR to the earliest date of disease progression or death

  2. Time To Response, TTR

    Time frame: Up to approximately 24 months

    Time from the date of first infusion to the date of CR or PR

  3. Disease Control Rate, DCR

    Time frame: Up to approximately 24 months

    The percentage of subjects who experience CR, PR or stable disease (SD)

  4. Progression-Free Survival, PFS

    Time frame: Up to approximately 24 months

    Time from the date of first infusion to the earliest date of disease progression or death

  5. Overall Survival, OS

    Time frame: Up to approximately 24 months

    Time from the date of first infusion to the date of death

  6. Pharmacokinetics parameter, Tmax

    Time frame: Up to approximately 24 months

    Peak time

  7. Pharmacokinetics parameter, Cmax

    Time frame: Up to approximately 24 months

    Maximum concentration

  8. Pharmacokinetics parameter, AUC

    Time frame: Up to approximately 24 months

    Area under the concentration-time curve

  9. Pharmacokinetics parameter, t1/2

    Time frame: Up to approximately 24 months

    Half-life

  10. Pharmacokinetics parameter, V

    Time frame: Up to approximately 24 months

    Apparent volume of distribution

  11. Pharmacokinetics parameter, CL

    Time frame: Up to approximately 24 months

    Clearance

  12. Immunogenicity parameter

    Time frame: Up to approximately 24 months

    Anti-Drug Antibody (ADA) of 9MW2821

Study contacts

Contact information is provided by the study sponsor or research team.

Feng Wang

CONTACT

[email protected]

13938244776

Sponsors and collaborators

Lead sponsor

Mabwell (Shanghai) Bioscience Co., Ltd.

Industry

Registry information

Official study title

A Phase Ib/ll Clinical Study of Safety and Efficacy of 9MW2821 Monotherapy or Combined With Other Anticancer Therapy in Advanced Solid Tumors

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 27, 2025
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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