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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Unresectable or Metastatic Advanced Solid Tumors
• Intervention / Treatment: Drug: WTX212A

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Qi Zhang, M.D.; Phone Number: 13858108798; Email: qi.zhang@zju.edu.cn
• Study Contact Backup: Name: Qihan Fu, M.D.; Email: ayfuqihan@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

6. 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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WTX212A; WTX212A infusion once every 21 days	Drug: WTX212A; WTX212A infusion once every 21 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of adverse events	The incidence of Adverse Events during the treatment of WTX212A injection	through study completion, an average of 1 year
incidence of treatment related adverse events (TRAE)	The incidence of TRAE during the treatment of WTX212A injection	through study completion, an average of 1 year
incidence of severe adverse events (SAE)	The incidence of SAE during the treatment of WTX212A injection	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Cmax	through study completion, an average of 1 months
Tmax	Tmax	through study completion, an average of 1 months
AUC0-t	AUC0-t	through study completion, an average of 1 months
t1/2	t1/2	through study completion, an average of 1 months
CL	CL	through study completion, an average of 1 months
Cmin,ss	Cmin,ss	through study completion, an average of 1 months
Cmax,ss	Cmax,ss	through study completion, an average of 1 months
Tmax,ss	Tmax,ss	through study completion, an average of 1 months
AUC（0-τ）ss.	AUC（0-τ）ss.	through study completion, an average of 1 months
the occupancy rate of PD-1 receptor on the surface of peripheral blood T cells	the occupancy rate of PD-1 receptor on the surface of peripheral blood T cells in subjects after WTX212A infusion	through study completion, an average of 1 year
Objecive Response Rate (ORR)	According to Response Evaluation Criteria In Solid Tumors Version 1.1	through study completion, an average of 4 months
Anti-drug antibody (ADA)	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	through study completion, an average of 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-drug antibodies (ADA)	The proportion of anti-drug antibodies (ADA) after WTX212A infusion	through study completion, an average of 1 year
The absolute value of immune cell subsets	The absolute value of immune cell subsets	through study completion, an average of 1 year
The percentage of immune cell subsets	The percentage of immune cell subsets	through study completion, an average of 1 year
The proportion of PD-L1 expression in tumor cells/immune cells	The proportion of PD-L1 expression in tumor cells/immune cells	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Zhejiang University

Study record dates

Study Major Dates

• Study Start (Estimated): August 30, 2023
• Primary Completion (Estimated): August 30, 2024
• Study Completion (Estimated): May 30, 2025

Study Registration Dates

• First Submitted: August 21, 2023
• First Submitted That Met QC Criteria: September 6, 2023
• First Posted (Actual): September 7, 2023

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Reboot-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No