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NCT Number: NCT06026605

A Dose Escalation and Dose Expansion Trial of WTX212A in the Treatment of Patients with Advanced Malignant Tumors

This trial is a multi-center, open-label investigator-initiated clinical study (IIT) to evaluate the safety, pharmacokinetics, pharmacodynamics and effectiveness of WTX212A injection in the treatment of patients with unresectable or metastatic advanced solid tumors who failed in previous systematic therapy.

The study was divided into two phases: dose escalation and dose expansion

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

the First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location status: Recruiting

Location contact

Qi Zhang

CONTACT

13858108798

About this study

The study was divided into two phases: dose escalation and dose expansion Detailed Description: This trial is a multi-center, open-label investigator-initiated clinical study(llT)to evaluate the safety, pharmacokinetics, pharmacodynamics and effectiveness of WTX212A injection in the treatment of patients with unresectable or metastatic advanced solid tumors who failed in previous systematic therapy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 1. Must signs an informed consent form, understands this study, is willing to follow and has the ability to complete all experimental procedures; 2. Aged 18 to 75 years old (including threshold); 3. Histopathology diagnosed unresectable or metastatic solid tumors who have failed systemic treatment or have no effective standard treatment, or who are unwilling to accept standard treatment or are not suitable for standard treatment; 4. ECOG≤1; 5. Expected life ≥ 3 months; 6. Male participants, their spouses, and female participants of childbearing age should agree to use a medically recognized effective contraceptive method from the signing of the informed consent form until 3 months after the last administration; 7. Women of childbearing age must have a negative pregnancy testing results within ≤ 7 days before the first trial drug administration.

Exclusion criteria

  • 1. Other serious medical diseases, including but not limited to: uncontrolled diabetes, active peptic ulcer, active bleeding, etc., and people with uncontrollable or serious cardiovascular diseases, 2. Pleural and ascitic fluids with clinical symptoms and the need for repeated drainage; 3. Previous or recent history of pulmonary fibrosis, severe lung function damage caused by pneumoconiosis, radiation pneumonia, and drug-related pneumonia; 4. History of adverse events related to the use of IO drugs that require permanent cessation of IO treatment; 5. Known to have other malignant tumors, currently progressing or completing treatment at least once in the past 3 years.
  • Symptomatic central nervous system (CNS) metastasis confirmed by imaging or pathological examination and clinically unstable for at least 14 days prior to enrollment who require steroid treatment; 7. Hereditary bleeding tendencies or coagulation disorders, or a history of thrombosis, hemolysis, or hemorrhagic diseases; 8. Received significant surgical treatment or obvious traumatic injury within 28 days prior to the start of research treatment;

Treatment and study plan

WTX212A

Drug

WTX212A infusion once every 21 days

Primary outcomes

  1. incidence of adverse events

    Time frame: through study completion, an average of 1 year

    The incidence of Adverse Events during the treatment of WTX212A injection

  2. incidence of treatment related adverse events (TRAE)

    Time frame: through study completion, an average of 1 year

    The incidence of TRAE during the treatment of WTX212A injection

  3. incidence of severe adverse events (SAE)

    Time frame: through study completion, an average of 1 year

    The incidence of SAE during the treatment of WTX212A injection

Secondary outcomes

  1. Cmax

    Time frame: through study completion, an average of 1 months

    Cmax

  2. Tmax

    Time frame: through study completion, an average of 1 months

    Tmax

  3. AUC0-t

    Time frame: through study completion, an average of 1 months

    AUC0-t

  4. t1/2

    Time frame: through study completion, an average of 1 months

    t1/2

  5. CL

    Time frame: through study completion, an average of 1 months

    CL

  6. Cmin,ss

    Time frame: through study completion, an average of 1 months

    Cmin,ss

  7. Cmax,ss

    Time frame: through study completion, an average of 1 months

    Cmax,ss

  8. Tmax,ss

    Time frame: through study completion, an average of 1 months

    Tmax,ss

  9. AUC(0-τ)ss.

    Time frame: through study completion, an average of 1 months

    AUC(0-τ)ss.

  10. the occupancy rate of PD-1 receptor on the surface of peripheral blood T cells

    Time frame: through study completion, an average of 1 year

    the occupancy rate of PD-1 receptor on the surface of peripheral blood T cells in subjects after WTX212A infusion

  11. Objecive Response Rate (ORR)

    Time frame: through study completion, an average of 4 months

    According to Response Evaluation Criteria In Solid Tumors Version 1.1

  12. Anti-drug antibody (ADA)

    Time frame: through study completion, an average of 1 year

    escribe the number and percentage of anti-drug antibodies (ADA) produced by subjects at each time point after treatment, and the time of producing ADA

Other outcomes

  1. Anti-drug antibodies (ADA)

    Time frame: through study completion, an average of 1 year

    The proportion of anti-drug antibodies (ADA) after WTX212A infusion

  2. The absolute value of immune cell subsets

    Time frame: through study completion, an average of 1 year

    The absolute value of immune cell subsets

  3. The percentage of immune cell subsets

    Time frame: through study completion, an average of 1 year

    The percentage of immune cell subsets

  4. The proportion of PD-L1 expression in tumor cells/immune cells

    Time frame: through study completion, an average of 1 year

    The proportion of PD-L1 expression in tumor cells/immune cells

Study contacts

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

Qi Zhang, M.D.

CONTACT

[email protected]

13858108798

Qihan Fu, M.D.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Official study title

A MulticenterOpen LableDose Escalat Tion and Dose Expansion Clinical Study to Evaluate the Safety, Tolerance and Ini Itial Effectiveness of WTX212A Injection in Patients with Unresectable or Metasta Atic Advanced Solid Tumors

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 7, 2023
Registry last updated
Jan 16, 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.