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Advanced Solid TumorsPhase 1/2NCT05824455

A Clinical Study of IMP4297 Capsule (JS109) Combined With Irinotecan in the Treatment of Advanced Malignant Solid Tumors

A Phase 1/2 study testing JS109 combine with irinotecan in people with Advanced Solid Tumors, run by Shanghai Jun Pai Ying Shi Therapeutics 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 Phase Ib study was designed to evaluate the safety of JS109 in combination with irinotecan in the treatment of advanced solid tumors and to determine the Phase II recommended dose (RP2D). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumors
What is being tested?
JS109 combine with irinotecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteChina
Study dates
23 Mar 2023to 28 Sep 2023
Phase
Phase 1/2
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 75 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 ≤75 years when the subject signed the informed consent;
  • Histologically confirmed advanced malignant solid tumor(phase Ib: Subjects with advanced malignant solid tumors who have failed standard therapy, do not currently have or refuse standard therapy, or are intolerant to standard therapy, and who have received no more than 3 lines of systemic therapy for advanced disease;phase II:Subjects with extensive stage SCLC who developed disease progression after receiving only the first-line standard platinum-containing regimen; Or subjects with localized SCLC who have progressed or relapsed after receiving prior chemoradiotherapy (platinum-containing chemotherapy), and the treatment free interval from the end of chemotherapy, radiotherapy, or chemoradiotherapy to the diagnosis of extensive stage SCLC is no more than 6 months);
  • There should be at least one measurable lesion according to RECIST V1.1 evaluation criteria(Phase II only);
  • The expected survival is ≥3 months;
  • The physical status score is 0 or 1 on the Eastern Oncology Collaboration (ECOG) scale;
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  • 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

  • Histologically confirmed combined SCLC or transformed SCLC ;
  • Known allergy to study drug or excipients;
  • Prior treatment with drugs or other therapies that target PARP;
  • Had been treated with irinotecan in the past;
  • Subjects who received a CYP3A4 potent inhibitor or CYP3A4 potent inducer prior to the first investigational agent (≥5 half-lives from the first investigational agent to qualify for inclusion) and who required continued treatment with these agents during the study period;
  • Inability to swallow oral formulations and gastrointestinal dysfunction may interfere with study drug absorption;
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  • Subjects with malignancies other than target cancer (other than cured cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ of the breast) within 5 years prior to the first dose ;
  • Pregnant or lactating female subjects;
  • Myelodysplastic syndrome (MDS)/acute myelocytic cell (AML) leukemia subjects;
  • Known history of allogeneic organ transplantation or allohematopoietic stem cell transplantation;
  • Active central nervous system metastasis. Treated subjects with brain metastases were enrolled if they met the following criteria: corticosteroid therapy should be discontinued at least 7 days before the first dose; No disease progression was observed on imaging examinations from the end of brain orientation therapy to the time of randomization, when compared with pre-treatment imaging (at least 4 weeks apart);
  • Known to have Gillbert syndrome;
  • Clinically significant gastrointestinal disorders such as chronic inflammatory bowel disease and/or intestinal obstruction or diarrhea > grade 1.
  • Poorly controlled pleural effusion, peritoneal effusion or pericardial effusion (Hydrothorax and Ascites drainage frequency ≥1 time/month); Subjects who need to be stabilized for at least 1 week prior to the first dose after drainage (stable is defined as no definite increase in pleural fluid without any intervention) can be enrolled;
  • Poorly controlled tumor-related pain;
  • Myocardial infarction, severe/unstable angina, NYHA grade 2 or higher cardiac insufficiency, clinically significant supracentricular or ventricular arrhythmias, and symptomatic congestive heart failure, hypertensive crisis, or hypertensive encephalopathy during the 6 months preceding of the first dose; Known hypertension, coronary artery disease, congestive heart failure, congestive heart failure that does not meet the above criteria or patients with left ventricular ejection fraction <50% must be treated with an optimal stabilization regimen as determined by the treating physician;
  • Participated in or planned to participate in other interventional studies, received systemic antitumor therapy, underwent major surgery, and received radiation therapy for radical treatment within 28 days prior to the first dose;
  • Severe infection( CTCAE>Grade 2) occurred within 28 days prior to the first dose, such as severe pneumonia, bacteremia, infection comorbidities that require hospitalization;
  • Active infections, including, but not limited to, tuberculosis (clinical diagnosis including clinical history, physical examination and imaging findings, as well as TB testing based on local medical practices), hepatitis B, hepatitis C or human immunodeficiency virus;
  • The investigators judged a history of clinically significant liver disease, including active viral activity (Same as the definition of exclusion Criterion 19) or other hepatitis, a history of alcohol abuse, or cirrhosis;
  • The presence of other serious physical or mental illnesses, abnormalities in laboratory tests, alcohol or drug abuse that may increase the risk of study participation, affect treatment compliance, or interfere with study results, and other subjects who are deemed unsuitable for the study by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510062

Other trials in China

About this study

Official title: An Open, Multicenter, Phase Ib/II Clinical Study of IMP4297 Capsule (JS109) Combined With Irinotecan in the Treatment of Advanced Malignant Solid Tumors

The Phase Ib study was designed to evaluate the safety of JS109 in combination with irinotecan in the treatment of advanced solid tumors and to determine the Phase II recommended dose (RP2D). The Phase II study was designed to evaluate the efficacy and safety of the combination regimen in patients with extensive small-cell lung cancer (SCLC) that failed first-line platinum-containing regimen.

Being tested
JS109 combine with irinotecan

What participants receive

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

  • JS109 combine with irinotecanCombination product

    JS109 PO,QD, q3w combine with irinotecan(65mg/m2,IV,D1,8,Q3w)

Study groups in NCT05824455
Study groupRoleWhat they receive
JS109 combination with irinotecanExperimentalNot described
Receives: Combination Product: JS109 combine with irinotecan

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 16 months from first patient in.

  2. Incidence and severity of AE

    The incidence and severity of adverse events (AE)

    Measured: Up to approximately 16 months from first patient in.

  3. Incidence and severity of SAE

    The incidence and severity of serious adverse events (SAE)

    Measured: Up to approximately 16 months from first patient in.

  4. Abnormal changes in laboratory and other tests of clinical significance

    The incidence and severity of abnormal changes in laboratory and other tests of clinical significance

    Measured: Up to approximately 16 months from first patient in.

Secondary outcomes (21)

  1. MTD

    Determine maximum tolerated dose (MTD, if possible)

    Measured: Up to approximately 16 months from first patient in.

  2. RP2D

    Recommended phase II dose (RP2D) for JS109 combination therapy

    Measured: Up to approximately 16 months from first patient in.

  3. Tmax

    Peak time

    Measured: Up to approximately 16 months from first patient in.

  4. Cmax

    Peak concentration

    Measured: Up to approximately 16 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 16 months from first patient in.

  6. AUC0-INF

    Area under the curve from time zero to infinity

    Measured: Up to approximately 16 months from first patient in.

  7. Vd/F

    Apparent volume of distribution

    Measured: Up to approximately 16 months from first patient in.

  8. CL/F

    Clearance

    Measured: Up to approximately 16 months from first patient in.

  9. t1/2

    Elimination half-life

    Measured: Up to approximately 16 months from first patient in.

  10. Css, Max

    Steady-state peak concentration Degree (Css, Max)

    Measured: Up to approximately 16 months from first patient in.

  11. Css, min

    Steady state minimum observed concentration

    Measured: Up to approximately 16 months from first patient in.

  12. Cav,ss

    Mean blood drug concentration at steady-state

    Measured: Up to approximately 16 months from first patient in.

  13. Tmax,ss

    Peak time at steady state

    Measured: Up to approximately 16 months from first patient in.

  14. AUCss

    Steady-state area under curve (AUCss)

    Measured: Up to approximately 16 months from first patient in.

  15. Rac

    Accumulation ratio (Rac)

    Measured: Up to approximately 16 months from first patient in.

  16. FD

    Fluctuation coefficient

    Measured: Up to approximately 16 months from first patient in.

  17. ORR

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

    Measured: Up to approximately 16 months from first patient in.

  18. DOR

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

    Measured: Up to approximately 16 months from first patient in.

  19. DCR

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

    Measured: Up to approximately 16 months from first patient in.

  20. PFS

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

    Measured: Up to approximately 16 months from first patient in.

  21. OS

    Overall survival (OS)

    Measured: Up to approximately 16 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 posted21 Apr 2023
  2. Study start23 Mar 2023
  3. Primary completion28 Sep 2023
  4. Study completion28 Sep 2023

Why it stopped: The sponsor voluntarily requested termination

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
Sequential
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05824455
Sponsor's protocol ID
JS109-003-Ib/II
Status last verified
Sep 2024
First submitted
9 Apr 2023
Last updated
5 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing JS109 combine with irinotecan in people with Advanced Solid Tumors, run by Shanghai Jun Pai Ying Shi Therapeutics 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 9 inclusion and 21 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 5 Sep 2024. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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: The sponsor voluntarily requested termination). 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 16 months from first patient in.). The study lists 4 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 NCT05824455.

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 5 Sep 2024.

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