A Study Explore WJ01075 Tablets in Patients With Advanced Solid Tumors

NCT05470933 | Terminated Phase 1

• 1 other identifier: JS124-001-I
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I study to Investigate the safety and tolerability, DLT(Dose limited toxicity), MTD(Maximum tolerated dose), and RP2D(Recommended phase II dose) of WJ01075 tablets in patients with advanced malignant solid tumors, including phase Ia (dose escalation phase) and Phase Ib (dose expansion phase,cohort expansion phase).The study includes screening, treatment and follow-up periods. In phase Ia, accelerated titration (the first two dose groups) and "3 + 3" combination (the subsequent dose group) were used for dose escalation. In phase Ib, specific dose groups will be selected for dose expansion according to PK(Pharmacokinetics) and safety data of different dose groups in dose escalation phase.It is planned that SMC(Safety Monitoring Committee) will select one or more dose groups based on previous data for cohort expansion studies to further determine RP2D, safety tolerability and initial efficacy.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (5)

• Dose limited toxicity (DLT)

  incidence and severity of Dose limited toxicity(DLT);

  3 years

• Adverse event (AE)

  incidence and severity of adverse event (AE), Abnormal changes in laboratory and other tests of clinical significance;

  3 years

• Serious adverse event (SAE)

  incidence and severity of Serious adverse event (SAE);

  3 years

• Maximum tolerated dose (MTD)

  Maximum tolerated dose (MTD)

  2 years

• Recommended phase II dose (RP2D)

  Recommended phase II dose (RP2D)

  2 years

Secondary Outcomes (21)

• Objective response rate(ORR)

  2 years

• Duration of response (DOR)

  2 years

• Disease control rate (DCR)

  2 years

• Time to response(TTR)

  2 years

• Progression-free survival (PFS)

  2 years

Study Arms (1)

WJ01075 tablets

EXPERIMENTAL

Once a week (QW).

Drug: WJ01075

Interventions

WJ01075 DRUG

Phase Ia: Dose Escalation Accelerated titration (the first two dose groups) and "3 + 3" combination (the subsequent dose group) were used for dose escalation. Phase Ib: Dose Expansion and Cohort Expansion The actual dose, dosing schedule (including combination) and indication selection will be evaluated based on the results of existing trials.

WJ01075 tablets

Eligibility Criteria

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

You may qualify if:

• Patient with advanced malignant solid tumors clearly diagnosed pathologically and/or cytologically, who have failed to receive standard treatment, or who currently do not/or refuse standard treatment, or who are intolerant to standard treatment;
• Patient must have at least one measurable lesion as defined per RECIST v1.1;
• Aged between 18 and 75 (including 18 and 75), male and female patients;
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score ≤1;
• Life expectancy ≥ 3 months;
• The functions of patients' major organs were basically normal, and the laboratory tests performed within 7 days prior to the first administration of study drugmet the following criteria, Patients must not have required a blood transfusion or growth factor support within 14 days before the examination:
• Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤2.5 × Upper limit of Normal (ULN); Total Bilirubin≤ 1.5×ULN; International Normalized Ratio (INR) ≤1.5; Creatinine ≤ 1.5 × ULN, and Creatinine Clearance Rate (calculated by Cockcroft-Gault formula) ≥ 50 mL/min; Hemoglobin (Hg) ≥ 90g/L; Platelets ≥ 100×10⋀9/L; Absolute Neutrophil Count(ANC) ≥ 1.5×10⋀9/L
• Fertile women must confirm a negative blood pregnancy test within 7 days prior to the first administration of study drug;All enrolled patients (both male and female) are required to use adequate and effective contraceptive measures throughout the treatment period and within 3 months after the end of treatment;
• Those who voluntarily participate in the study and sign the written Informed Consent Form upon full informed consent.

You may not qualify if:

• Prior treatment with XPO1 inhibitors;
• Have a history of allergy to any component or excipient of WJ010175 tablets;
• Patient with a primary malignancy other than the tumor treated in the study within 5 years prior to the first administration of study drug (exceptions include cured malignancies that did not recur within 3 years prior to enrollment;Basal cell and squamous cell carcinoma completely resected;Complete excision of any type of carcinoma in situ, etc.);
• Received other anti-tumor therapies, including but not limited to chemotherapy, radiotherapy, targeted therapy, immunotherapy and other anti-tumor therapies (such as anti-tumor traditional Chinese medicine), within 4 weeks or 5 half-life periods (whichever is longer) prior to the first administration of study drug;Or long-term treatment with potent CYP1A2 inhibitors, potent CYP3A4 inducers and potent CYP3A4 inhibition;
• Thrombosis or embolism occurred within 6 months prior to the first administration of study drug;
• Received medium or major surgical treatment within 4 weeks prior to the first administration of study drug, other than diagnostic biopsy ;
• Any of the following conditions within 6 months prior to the first administration of study drug: New York Cardiology Association (NYHA) \> Grade II cardiac insufficiency, congestive heart failure, severe/unstable angina pectoris (symptoms of resting angina pectoris), myocardial infarction, arrhythmias requiring treatment, uncontrolled hypertension or hypertensive crisis or hypertensive encephalopathy;
• Adverse events and/or complications caused by previous treatment are not relieved to \< Level 2 (per NCI-CTCAE V5.0);Any level of hair loss/pigmentation and long-term toxicity caused by other treatment, other than those that the investigator diagnosiss cannot be recovered and do not affect study administration or compliance and patient safety;
• Patient with central nervous system metastasis or tumors originating in the central nervous system;,
• Patient with grade ≥ 2 neuropathy (per NCI-CTCAE V5.0);
• Severe infections requiring antibiotic treatment within 14 days prior to the first administration of study drug ( \> CTCAE Grade 2 ), such as severe pneumonia, bacteremia, infection complications requiring hospitalization;
• Uncontrolled pericardial effusion, pleural effusion or clinically obvious moderate to severe abdominal effusion during screening is defined as meeting the following criteria: having clinical symptoms and detectable thoracic and abdominal effusion during physical examination;Or in the screening process, the thoracoabdominal effusion needs to be punctured pumping liquid and/or intravenously administered;
• Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
• Patient has serious psychological or mental abnormalities affecting the compliance of the subjects to participate in the study;
• With active Hepatitis B, or Hepatitis C, or Human Immunodeficiency Virus positive \[HIV (+)\] and syphilis antibody (+);Note: Hepatitis B virus surface Antigen (HBsAg) or core antibody (HBcAb) positive should be tested for HBV-DNA, and HBV-DNA should be below the lower limit of the reference range.Patients who are positive for Hepatitis C virus Antibody (HCV Ab) will be tested for HCV RNA and can be enrolled if they are below the upper limit of normal.

Sponsors & Collaborators

• Suzhou Junjing BioSciences Co., Ltd.: lead

Study Sites (1)

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Group

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 22, 2022
• Study Start: August 23, 2022
• Primary Completion: April 18, 2023
• Study Completion: April 18, 2023
• Last Updated: September 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)