A Clinical Study to Evaluate the Safety and Tolerability of JS012 in Advanced or Metastatic Solid Tumors

NCT05388279 | Terminated Phase 1 DMC

• 1 other identifier: JS012-001-I
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this phase I clinical study was to evaluate the safety and tolerability of JS012 monotherapy and combination with chemotherapy in patients with Advanced or Metastatic Solid Tumors.

Conditions

Advanced or Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (5)

• Incidence of DLT

  The Incidence of dose-limiting toxicity（DLT）

  Up to approximately 41 months from first patient in.

• Incidence and severity of AE

  The incidence and severity of adverse events (AE)

  Up to approximately 41 months from first patient in.

• Incidence and severity of SAE

  The incidence and severity of serious adverse events (SAE)

  Up to approximately 41 months from first patient in.

• MTD

  Determine maximum tolerated dose (MTD, if possible)

  Up to approximately 41 months from first patient in.

• RP2D

  Recommended phase II dose (RP2D) for JS012 monotherapy and combination therapy

  Up to approximately 41 months from first patient in.

Secondary Outcomes (23)

• Drug concentrations

  Up to approximately 41 months from first patient in.

• Cmax

  Up to approximately 41 months from first patient in.

• Tmax

  Up to approximately 41 months from first patient in.

• Ctrough

  Up to approximately 41 months from first patient in.

• AUC0-T

  Up to approximately 41 months from first patient in.

Study Arms (2)

JS012

EXPERIMENTAL

Drug: JS012

JS012 combination with chemotherapy

EXPERIMENTAL

Combination Product: JS012 combine with chemotherapy

Interventions

JS012 DRUG

JS012, i.v., q3w

JS012

JS012 combine with chemotherapy COMBINATION_PRODUCT

JS012 i.v., q3w combine with chemotherapy

JS012 combination with chemotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subjects voluntarily participated in the study with full informed consent and signed written informed consent form;
• Aged ≥18 years and ≤70 years when the subject signed the informed consent;
• Locally advanced unresectable or metastatic malignant solid tumors diagnosed histologically ;
• Provide past tumor samples or fresh tumor tissue biopsy samples;
• There should be at least one measurable lesion according to RECIST V1.1 evaluation criteria;
• The expected survival is ≥3 months;
• The physical status score is 0 or 1 on the Eastern Oncology Collaboration (ECOG) scale;
• Good organ function;
• Within 7 days prior to the first dose, women of reproductive age must be confirmed as having a negative serum pregnancy test and consent to use effective contraception during the duration of study drug use and for 90 days after the last dose. Male patients with a female partner of reproductive age agreed to use effective contraception during the study drug use period and for 90 days after the last dose.

You may not qualify if:

• A history of severe allergic reactions to other monoclonal antibodies or to any component of JS012, or to other drugs or excipients involved in the trial protocol ;
• Prior treatment with drugs or other therapies targeting CLDN18.2;
• Malignant tumors other than the target tumor within 5 years before the first dose (except for cured cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer, or breast ductal carcinoma in situ);
• Pregnant or lactation female patients;
• History of allogeneic organ transplantation or hematopoietic stem cell transplantation;
• Presence of uncontrolled or symptomatic active central nervous system (CNS) metastases;
• Poorly controlled pleural effusion, peritoneal effusion or pericardial effusion (thoracoabdominal drainage frequency ≥1 times/month) ;
• Clinically significant ileus;
• Poorly controlled tumor-related pain;
• BMI less than 17.5 at the time of signing the informed consent, or weight loss \>10% in the first 2 months (significant pleural effluents should be considered) or other indicators of severe malnutrition;
• The following within 6 months prior to the first study dose: myocardial infarction, severe/unstable angina, NYHA class 2 or higher cardiac insufficiency, clinically significant supraventricular or ventricular arrhythmia, and symptomatic congestive heart failure , hypertensive crisis, or hypertensive encephalopathy; patients with known hypertension, coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction \<50% must be treated with optimal stabilization as determined by the treating physician medical plan;
• Received a drug or treatment prohibited by the protocol prior to the first dose;
• Serious infection (CTC AE\> grade 2) occurred within 28 days before the first dose, such as severe pneumonia, bacteremia, infectious complications requiring hospitalization, etc.
• Active infection;
• History of autoimmune disease;

Sponsors & Collaborators

• Shanghai Junshi Bioscience Co., Ltd.: lead

Study Sites (1)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

MeSH Terms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Yi Ba, M.D.

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Sequential

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 24, 2022
• Study Start: April 28, 2022
• Primary Completion: September 19, 2022
• Study Completion: September 19, 2022
• Last Updated: March 23, 2023

Record last verified: 2023-03

Locations

CN (1)