NCT05388279
Terminated
Phase 1
A Phase I Clinical Study Evaluating the Safety ,Tolerability, Pharmacokinetics of JS012 in Patients With Advanced or Metastatic Solid Tumors
Shanghai Junshi Bioscience Co., Ltd.1 site in 1 country3 target enrollmentApril 28, 2022
ConditionsAdvanced or Metastatic Solid Tumors
DrugsJS012
Overview
- Phase
- Phase 1
- Intervention
- JS012
- Conditions
- Advanced or Metastatic Solid Tumors
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Incidence and severity of AE
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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;
- •Any adverse events and/or complications resulting from prior treatment, including surgery or radiation therapy, that have been adequately resolved to level 0 or 1 (according to the NATIONAL Cancer Institute Standard for General Terminology of Adverse Events (NCI-CTCAE 5.0) or to the level specified in the inclusion criteria; Any grade of hair loss/pigmentation and other long-term toxicity caused by treatment, except those that are irreversible and do not affect study dosing/compliance and patient safety at the discretion of the investigator;
- •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.
Exclusion Criteria
- •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;
Arms & Interventions
JS012
Intervention: JS012
JS012 combination with chemotherapy
Intervention: JS012 combine with chemotherapy
Outcomes
Primary Outcomes
Incidence and severity of AE
Time Frame: Up to approximately 41 months from first patient in.
The incidence and severity of adverse events (AE)
Incidence and severity of SAE
Time Frame: Up to approximately 41 months from first patient in.
The incidence and severity of serious adverse events (SAE)
MTD
Time Frame: Up to approximately 41 months from first patient in.
Determine maximum tolerated dose (MTD, if possible)
RP2D
Time Frame: Up to approximately 41 months from first patient in.
Recommended phase II dose (RP2D) for JS012 monotherapy and combination therapy
Incidence of DLT
Time Frame: Up to approximately 41 months from first patient in.
The Incidence of dose-limiting toxicity（DLT）
Secondary Outcomes
- 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.)
- AUC0-INF(Up to approximately 41 months from first patient in.)
- t1/2(Up to approximately 41 months from first patient in.)
- CL(Up to approximately 41 months from first patient in.)
- MRT(Up to approximately 41 months from first patient in.)
- Vss(Up to approximately 41 months from first patient in.)
- Css, Max(Up to approximately 41 months from first patient in.)
- Css, min(Up to approximately 41 months from first patient in.)
- AUCss(Up to approximately 41 months from first patient in.)
- Rac(Up to approximately 41 months from first patient in.)
- Immunogenicity(Up to approximately 41 months from first patient in.)
- ADCC(Up to 21 days from pre-dose of JS012 administration in cycle 1 for each subject in the dose escalation and dose expansion phases)
- CDC(Up to 21 days from pre-dose of JS012 administration in cycle 1 for each subject in the dose escalation and dose expansion phases)
- ORR(Up to approximately 41 months from first patient in.)
- DOR(Up to approximately 41 months from first patient in.)
- DCR(Up to approximately 41 months from first patient in.)
- TTR(Up to approximately 41 months from first patient in.)
- PFS(Up to approximately 41 months from first patient in.)
- OS(Up to approximately 41 months from first patient in.)
Study Sites (1)
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