WTX212A Monotherapy and in Combination With PD -1/PD-L1 Monoclonal Antibody

NCT06106152 | Recruiting Early Phase 1

• 1 other identifier: Reboot-105
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is a single-center, open-label designed investigator-initiated clinical study (IIT) to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of WTX212A injection WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in patients with advanced lung cancer

Conditions

Advanced Lung Cancer

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy of WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in the treatment of patients with IO- resistant advanced lung cancer.

  Overall Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors Version 1.1

  1 year

Secondary Outcomes (3)

• the safety of WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in the treatment of IO- resistant advanced lung cancer patients

  1 year

• To evaluate the pharmacokinetic ( PK ) characteristics of WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in patients with IO- resistant advanced lung cancer

  1 year

• To evaluate the immunogenicity of WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in patients with IO -resistant advanced lung cancercheckpoint inhibitor resistance in advanced lung cancer patients

  1 year

Other Outcomes (3)

• To evaluate the pharmacodynamics ( PD ) characteristics of WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in patients with IO- resistant advanced lung cancer

  1 year

• To explore and evaluate WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in the treatment of IO- resistant advanced lung cancer before and after treatment, analysis of immune cell subpopulations

  1 year

• To explore and evaluate the changes in spleen size in patients with IO- resistant advanced lung cancer before and after treatment with WTX212A injection combined with PD -1/PD-L1 monoclonal antibody

  1 year

Study Arms (2)

Fixed-dose in patients with advanced lung cancer

EXPERIMENTAL

WTX212A injection Fixed-dose in advanced lung cancer patients

Drug: WTX212A injection

Combined Study in patients with advanced lung cancer

EXPERIMENTAL

Fixed-dose WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in patients with advanced lung cancer

Drug: WTX212A injection; Drug: PD -1/PD-L1 monoclonal antibody

Interventions

WTX212A injection DRUG

The WTX212A infusion is given every 21 days

Also known as: autologous red blood cell PD-1 inhibitor conjugate

Combined Study in patients with advanced lung cancer; Fixed-dose in patients with advanced lung cancer

PD -1/PD-L1 monoclonal antibody DRUG

The PD -1/PD-L1 monoclonal antibody is given every 21 days

Also known as: PD -1/PD-L1antibody

Combined Study in patients with advanced lung cancer

Eligibility Criteria

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

You may qualify if:

• The subject signs an informed consent form, understands this study, is willing to follow and has the ability to complete all experimental procedures;
• Regardless of gender, aged 18 to 75 years old (including threshold);
• Histologically or cytologically confirmed locally advanced (stage IIB/IIC) or metastatic (stage IV) non-small cell lung cancer (NSCLC) with disease progression or intolerance after treatment or extensive stage small cell Lung cancer (SCLC)
• Patients with lung cancer who have been treated with at least 1 line system therapy or cannot currently receive standard therapy, and who have been treated with PD-1 or PD-L1 inhibitor antibody in the terminal line therapy regimen for ≥ 2 cycles;
• ECOG ≤1
• Expected life ≥ 3 months；
• 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;

You may not qualify if:

• People with 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,
• Patients with clinical symptoms and the need for repeated drainage of pleural and ascitic fluids;
• Previous or recent history of pulmonary fibrosis, severe lung function damage caused by pneumoconiosis, radiation pneumonia, and drug-related pneumonia;
• There have been adverse events related to the use of IO drugs that require permanent cessation of IO treatment;
• Known to have other malignant tumors, currently progressing or completing treatment at least once in the past 3 years. Exceptions include early tumors that have received radical treatment (carcinoma in situ or grade 1 tumor, non ulcerative primary melanoma with a depth of less than 1mm and no lymph nodes involved), skin basal cell carcinoma, skin squamous cell carcinoma, cervical carcinoma in situ, or breast carcinoma in situ that has received potential radical treatment;
• Subjects with 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;
• Having hereditary bleeding tendencies or coagulation disorders, or a history of thrombosis, hemolysis, or hemorrhagic diseases;
• Received significant surgical treatment or obvious traumatic injury within 28 days prior to the start of research treatment;

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Westlake Therapeutics: collaborator

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

Study Officials

• pingli wang, phD

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

pingli wang, phD

CONTACT

(0571)87783520; pingliwang@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Respiratory and Critical Care Medicine Department,pHD,MD

Model Details: Single-center, open-label, exploratory study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in patients with advanced lung cancer

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 30, 2023
• Study Start: December 5, 2023
• Primary Completion: October 30, 2024
• Study Completion: December 31, 2025
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)