AzTrials
AzTrials

Advanced Solid TumorPhase 1NCT05781386

A Phase I Trial of SIM1811-03 in Subjects With Advanced Tumors

A Phase 1 study testing SIM1811-03 or in combination with Sintilimab injectiont in people with Advanced Solid Tumor and Cutaneous T Cell Lymphoma, run by Jiangsu Simcere Biologics Co., Ltd at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This is a first in human, open-label, dose escalation and expansion Phase I study of SIM1811-03 in adult patients with advanced tumors. SIM1811-03 is a first-in-class IgG1-based humanized anti-tumor necrosis factor type 2 receptor (TNFR2) monoclonal antibody for the treatment of malignant tumors. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SIM1811-03 or in combination with Sintilimab injectiont
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
255 participants
Where
1 siteChina
Study dates
6 Mar 2022to 30 Dec 2025
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 must be obtained prior to any procedures that are not considered standard of care.
  • ≥18 years old on the day of signing informed consent, male or female;
  • Histologically and/or cytologically documented advanced/metastatic solid tumors or histologically confirmed CTCL;
  • Have relapsed or refractory advanced solid tumors or CTCL, whose disease has progressed during or after standard therapy
  • At least one measurable tumor lesion (RECIST 1.1) for participants with solid tumors. Tumor lesions previously treated with radiotherapy or local therapy should not be considered as measurable unless progression is documented.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
Show all 9Show fewer
  • Life expectancy of ≥ 12 weeks.
  • Adequate organ and marrow functions 9） Provide archived or fresh biopsy tumor tissue samples or tissue sections
  • 10) Females of childbearing potential require strict contraception during the study.

Who cannot join

  • 1) Participated in an interventional clinical trial or has used investigational devices within 28 days prior to first dose of study drug or received systemic anti-cancer treatments.
  • 2）Toxicity due to previous antineoplastic therapy has not recovered to grade 0 or 1 unless such AEs are not considered to pose safety risks.
  • 3) Required use of corticosteroids for more than 7 consecutive days within 14 days prior to the first dose of study treatment.
  • 4) Participated with active or history of or risk of autoimmune disease 5) Major surgery (except biopsy) or unhealed wound within 4 weeks prior to first dose of study drug.
  • 6) Other known malignancies within 2 years prior to enrollment. 7) Has known active central nervous system (CNS) metastases. 8) History of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis, symptomatic interstitial lung disease or evidence of active pneumonia that is not considered appropriate by the investigator.
  • 9) Participants with a history of active pulmonary tuberculosis infection within 1 year prior to first dose of study drug.
  • 10) History of hemorrhagic disease requiring transfusion within the last 3 months.

Trial locations and contacts

1 site in 1 country.

Jiongyan Li, MD contact

86(25)8556 6666

lijiongyan@zaiming.com

Jing Wang contact

wangjing16f919@zaiming.com

China1 site, 1 recruiting

  • Sun Yat-Sen University Cancer Center

    Guanzhou, Guangdong

    Ruihua Xu, MD, 86-20-8734-3468, xurh@sysucc.org.cn

    Recruiting

Other trials in China

About this study

Official title: An Open-label, Phase I Trial of SIM1811-03 to Assess the Safety, Efficacy and Pharmacokinetics/Pharmacodynamics in Subjects With Advanced Tumors

This is a first in human, open-label, dose escalation and expansion Phase I study of SIM1811-03 in adult patients with advanced tumors. SIM1811-03 is a first-in-class IgG1-based humanized anti-tumor necrosis factor type 2 receptor (TNFR2) monoclonal antibody for the treatment of malignant tumors.

Read the detailed description

This is a phase I trial to evaluate the safety, efficacy, and pharmacokinetic/ pharmacodynamic characteristics of SIM1811-03 in participants with advanced tumors.

The trial is composed of two parts, Part I and Part II. Part I is a dose escalation part to determine the MTD and/or RD of SIM1811-03 or SIM1811-03 in combination with Sintilimab Injection . Part II is a dose expansion part at RD level SIM1811-03 determined in Part I to assess the anti-tumor activity of SIM1811-03 or SIM1811-03 in combination with Sintilimab Injection in participants with advanced solid tumors or CTCL. The tumor types in Part II will be adjusted based on the response observed in Part I.

Being tested
SIM1811-03 or in combination with Sintilimab injectiont
Medical subject headings
Lymphoma, T-Cell, Cutaneous

What participants receive

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

  • SIM1811-03 or in combination with Sintilimab injectiontDrug

    SIM1811-03 is a first-in-class igG-1 based humanized anti-tumor necrosis factor type 2 receptor (TNFR2) monoclonal antibody for the treatment of malignant tumor.

    Sintilimab is an IgG4 humanized monoclonal antibody against programmed cell death protein 1 (PD-1)

Study groups in NCT05781386
Study groupRoleWhat they receive
SIM1811-03 monotherapy or SIM1811-03 in combination with Sintilimab injectionExperimentalAll participants receive SIM1811-03 or SIM1811-03 in combination with Sintilimab injection
Receives: Drug: SIM1811-03 or in combination with Sintilimab injectiont

What is being measured

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

  1. Part I The maximum tolerated dose (MTD) or recommended dose (RD)

    Part I (dose escalation): To estimate the maximum tolerated dose (MTD) or recommended dose (RD) of SIM1811-03 Monotherapy or in combination with sintilimab

    Measured: Within 28 days after the first dose in Q2W; Within 21 days after the first dose in Q3W

  2. Part II ORR for Solid Tumor

    Solid tumors: objective response rate (ORR) assessed by Investigator per RECIST 1.1 from baseline to disease progression

    Measured: Q2W: Participants will be evaluated every 8 weeks from baseline to Treatment Cycle 12 (an average of 1 year); Q3W:Participants will be evaluated every 6 weeks from baseline to Treatment Cycle 12 (an average of 1 year)

  3. Part II ORR for CTCL

    CTCL: ORR assessed by Investigator per global response score

    Measured: Q2W:Participants will be evaluated every 8 weeks from baseline to Treatment Cycle 12 (an average of 1 year); Q3W:Participants will be evaluated every 6 weeks from baseline to Treatment Cycle 12 (an average of 1 year)

Secondary outcomes (9)

  1. safety and tolerability (incidence of AE and SAE)

    Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

    Measured: All AEs/SAEs will be collected in this study from the time the subject signs the informed consent form until 90 days after the last dose

  2. Pharmacokinetics profile of SIM1811-03 and in combination with Sintilimab

    Serum concentrations of study drugs

    Measured: from Cycle 1 to Last dose (an average of 1 year)

  3. Pharmacokinetics profile of SIM1811-03 and in combination with Sintilimab

    Area under the concentration-time curve (AUC)

    Measured: from Cycle 1 to Last dose (an average of 1 year)

  4. Pharmacokinetics profile of SIM1811-03 and in combination with Sintilimab

    Maximum concentration (Cmax)

    Measured: from Cycle 1 to Last dose (an average of 1 year)

  5. Pharmacokinetics profile of SIM1811-03 and in combination with Sintilimab

    Pre-dose (trough) concentration (Ctrough)

    Measured: from Cycle 1 to Last dose (an average of 1 year)

  6. Pharmacokinetics profile of SIM1811-03 and in combination with Sintilimab

    Time to maximum concentration (Tmax)

    Measured: from Cycle 1 to Last dose (an average of 1 year)

  7. Pharmacokinetics profile of SIM1811-03 and in combination with Sintilimab

    Half-life (T1/2)

    Measured: Collection point would Predose, 0 hour, 24 hours, 168hours, 336 hours post-dose from Cycle 1 to Last dose (an average of 1 year)

  8. Antidrug antibodies of SIM1811-03 and Sintilimab

    Incidence of serum antidrug antibodies.

    Measured: before staring the treatment for the first 7 treatment cycles (each cycle would be 28 days/21 days)

  9. Neutralizing antibodies of SIM1811-03 and Sintilimab

    Incidence of neutralizing antibodies to study drugs.

    Measured: before staring the treatment for the first 7 treatment cycles (each cycle would be 28 days/21 days)

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 start6 Mar 2022
  3. Primary completion30 Jun 2025 (estimated)
  4. Study completion30 Dec 2025 (estimated)

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
Single group
Masking
None (open label)
Enrolment
255 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05781386
Sponsor's protocol ID
SIM1811-03-TNFR2-101
Status last verified
Mar 2023
First submitted
31 Jan 2023
Last updated
21 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gao Z, Zhang Q, Chen H, Chen J, Kang J, Yu H, Song Y, Zhang X. TNFR2 promotes pancreatic cancer proliferation, migration, and invasion via the NF-kappaB signaling pathway. Aging (Albany NY). 2023 Aug 16;15(16):8013-8025. doi: 10.18632/aging.204941. Epub 2023 Aug 16.

    PubMed 37589506

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SIM1811-03 or in combination with Sintilimab injectiont in people with Advanced Solid Tumor and Cutaneous T Cell Lymphoma, run by Jiangsu Simcere Biologics 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 7 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: status not confirmed, as of the sponsor's last update on 21 Sep 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?

Results are not available in the source record.

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

Contact Jiongyan Li, MD (86(25)8556 6666, lijiongyan@zaiming.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part I The maximum tolerated dose (MTD) or recommended dose (RD) (time frame: Within 28 days after the first dose in Q2W; Within 21 days after the first dose in Q3W). The study lists 3 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 NCT05781386, which also lists 1 linked publication.

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 21 Sep 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in