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Advanced or Metastatic Solid TumorsPhase 1NCT05388279

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

A Phase 1 study testing JS012 and JS012 combine with chemotherapy in people with Advanced or Metastatic Solid Tumors, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Advanced or Metastatic Solid Tumors
What is being tested?
JS012 and JS012 combine with chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteChina
Study dates
28 Apr 2022to 19 Sep 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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;
  • Idiopathic pulmonary fibrosis, drug-induced pneumonia, machine-induced pneumonia (bronchiolitis obliterans), radioactive pneumonia with clinical symptoms or requiring steroid treatment, active pneumonia, or other moderate to severe lung diseases that seriously affect lung function ;
  • Inability to swallow pills, malabsorption syndrome, or any condition that affects gastrointestinal absorption;
  • The presence of other serious physical or mental disorders or abnormal laboratory tests, or the presence of alcohol or drug abuse, may increase the risk of study participation, affect treatment compliance, or interfere with study results, as well as other patients deemed unsuitable for study participation by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300060

Other trials in China

About this study

Official title: A Phase I Clinical Study Evaluating the Safety ,Tolerability, Pharmacokinetics of JS012 in Patients With Advanced or Metastatic Solid Tumors

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.

Being tested
JS012, JS012 combine with chemotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JS012Drug

    JS012, i.v., q3w

  • JS012 combine with chemotherapyCombination product

    JS012 i.v., q3w combine with chemotherapy

Study groups in NCT05388279
Study groupRoleWhat they receive
JS012ExperimentalNot described
Receives: Drug: JS012
JS012 combination with chemotherapyExperimentalNot described
Receives: Combination Product: JS012 combine with chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of DLT

    The Incidence of dose-limiting toxicity（DLT）

    Measured: Up to approximately 41 months from first patient in.

  2. Incidence and severity of AE

    The incidence and severity of adverse events (AE)

    Measured: Up to approximately 41 months from first patient in.

  3. Incidence and severity of SAE

    The incidence and severity of serious adverse events (SAE)

    Measured: Up to approximately 41 months from first patient in.

  4. MTD

    Determine maximum tolerated dose (MTD, if possible)

    Measured: Up to approximately 41 months from first patient in.

  5. RP2D

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

    Measured: Up to approximately 41 months from first patient in.

Secondary outcomes (23)

  1. Drug concentrations

    Drug concentrations in individual subjects at different time points after dosing

    Measured: Up to approximately 41 months from first patient in.

  2. Cmax

    Peak concentration

    Measured: Up to approximately 41 months from first patient in.

  3. Tmax

    Peak time

    Measured: Up to approximately 41 months from first patient in.

  4. Ctrough

    Minimum concentration

    Measured: Up to approximately 41 months from first patient in.

  5. AUC0-T

    Area under the curve from time zero to the time of the t

    Measured: Up to approximately 41 months from first patient in.

  6. AUC0-INF

    Area under the curve from time zero to infinity

    Measured: Up to approximately 41 months from first patient in.

  7. t1/2

    elimination half-life

    Measured: Up to approximately 41 months from first patient in.

  8. CL

    clearance

    Measured: Up to approximately 41 months from first patient in.

  9. MRT

    mean retention time

    Measured: Up to approximately 41 months from first patient in.

  10. Vss

    steady-state apparent volume of distribution (Vss) (if applicable)

    Measured: Up to approximately 41 months from first patient in.

  11. Css, Max

    steady-state peak concentration Degree (Css, Max) (if applicable)

    Measured: Up to approximately 41 months from first patient in.

  12. Css, min

    Steady state minimum observed concentration (if applicable)

    Measured: Up to approximately 41 months from first patient in.

  13. AUCss

    steady-state area under curve (AUCss) (if applicable)

    Measured: Up to approximately 41 months from first patient in.

  14. Rac

    accumulation ratio (Rac) (if applicable)

    Measured: Up to approximately 41 months from first patient in.

  15. Immunogenicity

    Incidence of anti-drug antibody (ADA) and/or neutralizing antibody (Nab), titer of ADA positive samples

    Measured: Up to approximately 41 months from first patient in.

  16. ADCC

    Antibody Dependent cell-mediated cytotoxicity (ADCC)

    Measured: Up to 21 days from pre-dose of JS012 administration in cycle 1 for each subject in the dose escalation and dose expansion phases

  17. CDC

    Complement dependent cytotoxicity(CDC)

    Measured: Up to 21 days from pre-dose of JS012 administration in cycle 1 for each subject in the dose escalation and dose expansion phases

  18. ORR

    Objective response rate (ORR) was assessed based on RECIST V1.1 criteria

    Measured: Up to approximately 41 months from first patient in.

  19. DOR

    Duration of response (DOR) was assessed based on RECIST V1.1 criteria

    Measured: Up to approximately 41 months from first patient in.

  20. DCR

    Disease control rate (DCR) was assessed based on RECIST V1.1 criteria

    Measured: Up to approximately 41 months from first patient in.

  21. TTR

    Time to response (TTR) was assessed based on RECIST V1.1 criteria

    Measured: Up to approximately 41 months from first patient in.

  22. PFS

    Progression-free survival (PFS) was assessed based on RECIST V1.1 criteria

    Measured: Up to approximately 41 months from first patient in.

  23. OS

    Overall survival (OS)

    Measured: Up to approximately 41 months from first patient in.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2022
  2. Study start28 Apr 2022
  3. Primary completion19 Sep 2022
  4. Study completion19 Sep 2022

Why it stopped: Due to the adjustment and change of the sponsor's R\&D strategy, we now plan to voluntarily terminate this clinical trial.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
Sequential
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05388279
Sponsor's protocol ID
JS012-001-I
Status last verified
Mar 2023
First submitted
10 May 2022
Last updated
23 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JS012 and JS012 combine with chemotherapy in people with Advanced or Metastatic Solid Tumors, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Due to the adjustment and change of the sponsor's R\&D strategy, we now plan to voluntarily terminate this clinical trial.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of DLT (time frame: Up to approximately 41 months from first patient in.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05388279.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.

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