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Locally Advanced Unresectable or Metastatic Solid TumorPhase 1NCT05781360

A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0237 in Adult Participants with Advanced Solid Tumors

A Phase 1 study testing SIM0237 in people with Locally Advanced Unresectable or Metastatic Solid Tumor, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 9 sites in 2 countries.

Terminated

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

Official record
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Trial summary

This is a multicenter, open-label, phase I study to evaluate the safety, efficacy, and pharmacokinetic (PK)/pharmacodynamic(PD) characteristics of SIM0237 in participants with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SIM0237
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
192 participants
Where
9 sitesin 2 countries
Study dates
8 Mar 2023to 25 May 2024
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent;
  • ≥18 years of age;
  • Histological/cytological diagnosis of selected locally advanced unresectable or metastatic solid tumor not amenable to local therapies (clinical diagnosis of HCC is allowed); participants must have failed to derive clinical benefit on standard therapies, or ineligible for the standard of care therapy
  • Presence of at least one measurable lesion according to RECIST Version 1.1
  • ECOG performance status score of 0 or 1;
  • Life expectancy of ≥12 weeks;
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  • Participant must have adequate main organ function.
  • Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 72 hours prior to the start of study treatment. WOCBP must be willing to use either 2 adequate barrier methods or a barrier method plus a hormonal method of contraception to prevent pregnancy or to abstain from heterosexual activity throughout the study, starting from the first dose of the study treatment through 180 days after the last dose of study treatment.
  • Male participants must agree to use adequate contraception starting from the first dose of the study treatment through 180 days after the last dose of the study treatment.

Who cannot join

  • Within the defined washout periods for prior anti-cancer treatments;
  • Participant is currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of first dose of SIM0237.
  • Any other malignancy within 2 years prior to the first dose of the study treatment except for localized cancers that are considered to have been cured and in the opinion of the Investigator present a low risk for recurrence.
  • Participant has not recovered (i.e., to Grade 1 or to baseline) from previous anticancer therapy-induced AEs.
  • Participants with a history of recently (within previous 2 years of the first dose of the study treatment) active diverticulitis or symptomatic peptic ulcer disease;
  • Major surgery within 2 weeks of receiving the first dose of study treatment;
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  • Participant has symptomatic central nervous system (CNS) metastases, or CNS metastases requiring CNS-directed local therapy (such as radiotherapy or surgery) or corticosteroids therapy within 2 weeks of first dose of study treatment;
  • Participants with a history of active pulmonary tuberculosis infection within 1 year; participants with history more than 1 year prior to the first dose of study treatment may be considered suitable if there is no evidence of active pulmonary tuberculosis judged by the Investigator;
  • Participants with clinically significant cardiovascular diseases, in the past 6 months prior to the first dose of the study treatment; symptomatic coronary heart disease requiring drug treatment; arrhythmia requiring drug treatment; QTcF interval >480 msec; or uncontrolled hypertension;
  • Participants who have ascites requiring drainage or pleural effusion or pericardial effusion requiring drainage within 28 days after previous drainage; Known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS);
  • Active or chronic hepatitis B or hepatitis C infection; participant with HBsAg positive or detective HBV-DNA at screening should receive antiviral treatment as per local practice during the study.
  • Concomitant therapy with any other anti-cancer therapy or chronic use of immunosuppressive doses (more than 10 mg/day of prednisone or equivalent) of systemic corticosteroids.
  • Active known or suspected autoimmune disease.
  • History of non-infectious pneumonitis that has required a course of oral or intravenous steroids to assist with recovery, or interstitial lung disease or severe obstructive pulmonary disease;
  • History of severe hypersensitivity reactions to mAbs;
  • History of allogeneic organ transplantation or graft-versus-host disease;
  • Use of any live vaccine therapy within 4 weeks prior to the first dose of study treatment;
  • Any active infection requires systemic treatment via intravenous infusion within 2 weeks prior to the first dose of study treatment;
  • Known psychiatric disorder or drug abuse that would interfere the trial requirements;
  • Previous treatment with IL-15 agonists;
  • Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.
  • Other conditions that researchers consider inappropriate for inclusion.

Trial locations and contacts

9 sites in 2 countries.

9 sites in 2 countries

China6 sites

  • Hunan Cancer Hospital

    Changsha, Hunan, 410031

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

  • Anhui Provincial Hospital

    Hefei, Anhui, 230061

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003

Other trials in China

United States3 sites

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Indiana University Melvin and Bren Simon Comprehensive Cancer Center

    Indianapolis, Indiana, 46202

  • NYU Langone

    New York, New York, 10016

Other trials in United States

About this study

Official title: A Phase I First-in-human, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0237 in Adult Participants with Advanced Solid Tumors

This is a multicenter, open-label, phase I study to evaluate the safety, efficacy, and pharmacokinetic (PK)/pharmacodynamic(PD) characteristics of SIM0237 in participants with advanced solid tumors.

Read the detailed description

The study starts with a dose escalation part (Part 1) followed by a dose expansion part (Part 2). The main purpose of this study is to evaluate the safety and tolerability of SIM0237 and determine the maximum tolerated dose (MTD) (if any) and/or the recommended dose(s) (RD) and preliminary anti-tumor activity when given once every week or other dosing regimens. Additional purposes of the study are to evaluate the pharmacokinetics (PK) properties, immunogenicity, correlation of the biomarkers and PK profile with anti-tumor activity.

Being tested
SIM0237
Medical subject headings
Neoplasm Metastasis

What participants receive

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

  • SIM0237Drug

    SIM0237 should be administered intravenously at recommended dose qw or other dosing regimens

Study groups in NCT05781360
Study groupRoleWhat they receive
Experimental: PART ONE- Dose escalationExperimentalThe purpose of the Dose Escalation Phase (Part one) is to characterize the safety and tolerability of SIM0237 and determine the maximum tolerated dose (MTD) (if any) and/or the recommended dose(s) (RD) based on the frequency of the occurrence of DLTs in each cohort during the DLT evaluation period.
Receives: Drug: SIM0237
Experimental: PART TWO- Dose expansionExperimentalPatients will be administered a recommended dose of SIM0237 established from the Dose Escalation Phase of the study.
Receives: Drug: SIM0237

What is being measured

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

  1. Dose Escalation (Part One): Incidence and nature of Dose-Limiting Toxicity (DLT)

    DLTs will be defined using NCI CTCAE version 5.0 or ASTCT criteria for Cytokine Release Syndrome (CRS).

    Measured: 18 months

  2. Dose Escalation (Part One): Percentage of participants experiencing treatment-emergent adverse events (TEAEs)

    Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and lab abnormalities, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 and American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading

    Measured: 18 months

  3. Dose Escalation (Part One): Percentage of participants experiencing AE related dose interruptions and dose delays, dose intensity

    Occurrence of AE related dose interruptions, dose delays and dose intensity (duration of SIM0237 exposure).

    Measured: 18 months

  4. Dose Expansion (Part Two): Objective Response Rate (ORR)

    Proportion of participants who have a confirmed Complete Response (CR) or a Partial Response (PR), as the Best Overall Response (BOR) determined by Investigator per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Measured: 12 months

Secondary outcomes (13)

  1. Dose Expansion (Part Two): Percentage of participants experiencing treatment-emergent adverse events (TEAEs)

    Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and lab abnormalities, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 and American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading

    Measured: 18 months

  2. Dose Expansion (Part Two): Percentage of participants experiencing AE related dose interruptions and dose delays, dose intensity

    Occurrence of AE related dose interruptions, dose delays and dose intensity (duration of SIM0237 exposure).

    Measured: 18 months

  3. Dose Escalation and Expansion: Assessment of SIM0237 Cmax

    Maximum concentration observed (Cmax) observed from the PK profile

    Measured: 30 months

  4. Dose Escalation and Expansion: Assessment of SIM0237 AUC

    Area under the concentration versus time curve calculated using the trapezoidal method

    Measured: 30 months

  5. Dose Escalation and Expansion: Assessment of SIM0237 T1/2

    The time it takes for half the drug concentration to be eliminated calculated using slope of the terminal line

    Measured: 30 months

  6. Dose Escalation and Expansion: Assessment of SIM0237 antibody (ADA)

    Incidence, duration, titer of serum anti-SIM0237 ADA

    Measured: 30 months

  7. Dose Escalation (Part One): Objective Response Rate (ORR)

    Proportion of participants who have a confirmed complete response (CR) or a Partial Response (PR), as the Best Overall Response (BOR) determined by Investigator per the RECIST v1.1

    Measured: 48 months

  8. Dose Escalation and Expansion: Duration Of Response (DOR) assessed by investigator per RECIST Version 1.1

    DOR is defined as the time from the measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease.

    Measured: 48 months

  9. Dose Escalation and Expansion: Disease Control Rate (DCR) assessed by investigator per RECIST Version 1.1

    Disease Control Rate is defined as the percentage of participants who have achieved CR or PR or have demonstrated stable disease

    Measured: 48 months

  10. Dose Escalation and Expansion: Progression-Free Survival (PFS) assessed by investigator per RECIST Version 1.1

    PFS is defined as the time from the date of first administration of SIM0237 to the date of the first documented disease progression determined by Investigator as per RECIST 1.1 or death from any cause, whichever occurs first

    Measured: 48 months

  11. Dose Escalation and Expansion: Time-To-Progression (TTP) assessed by investigator per RECIST Version 1.1

    TTP is defined as the time from the date of first administration of SIM0237 to the date of the first documented disease progression

    Measured: 48 months

  12. Dose Escalation and Expansion: Overall Survival (OS)

    Overall Survival is defined as the time from the date of first administration of SIM0237 to death due to any cause

    Measured: 48 months

  13. Dose Escalation and Expansion: ORR in participants with different PD-LI expression levels

    ORR is defined as proportion of participants who have a confirmed Complete Response (CR) or a Partial Response (PR), as the Best Overall Response (BOR) determined by Investigator per RECIST v1.1. PD-L1 expression will be tested using 22C3 IHC and scored using TPS and/or CPS algorithm.

    Measured: 48 months

Timeline

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

  1. First posted23 Mar 2023
  2. Study start8 Mar 2023
  3. Primary completion25 May 2024
  4. Study completion25 May 2024

Why it stopped: An internal business decision, not based on safety or regulatory considerations.

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
192 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05781360
Sponsor's protocol ID
SIM0237-101
Status last verified
Dec 2024
First submitted
17 Feb 2023
Last updated
20 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SIM0237 in people with Locally Advanced Unresectable or Metastatic Solid Tumor, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 9 sites in 2 countries.

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 22 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 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in China, United States. 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: An internal business decision, not based on safety or regulatory considerations.). 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?

Dose Escalation (Part One): Incidence and nature of Dose-Limiting Toxicity (DLT) (time frame: 18 months). 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 NCT05781360.

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 20 Dec 2024.

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