An Open-label, Phase I Trial of SIM1811-03 to Assess the Safety, Efficacy and Pharmacokinetics/Pharmacodynamics in Subjects With Advanced Tumors
Sponsor study identifier
interventional
255
1 country
1
Study Start
March 6, 2022
Actual (reported)Primary Completion
June 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 6, 2022
Actual (reported)January 31, 2023
Actual (reported)March 23, 2023
Actual (reported)June 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Within 28 days after the first dose in Q2W; Within 21 days after the first dose in Q3W
Part II ORR for Solid Tumor
Solid tumors: objective response rate (ORR) assessed by Investigator per RECIST 1.1 from baseline to disease progression
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)
Part II ORR for CTCL
CTCL: ORR assessed by Investigator per global response score
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)
safety and tolerability (incidence of AE and SAE)
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
Pharmacokinetics profile of SIM1811-03 and in combination with Sintilimab
from Cycle 1 to Last dose (an average of 1 year)
Pharmacokinetics profile of SIM1811-03 and in combination with Sintilimab
from Cycle 1 to Last dose (an average of 1 year)
Pharmacokinetics profile of SIM1811-03 and in combination with Sintilimab
from Cycle 1 to Last dose (an average of 1 year)
Pharmacokinetics profile of SIM1811-03 and in combination with Sintilimab
from Cycle 1 to Last dose (an average of 1 year)
All participants receive SIM1811-03 or SIM1811-03 in combination with Sintilimab injection
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)
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These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Treatment programme
SIM1811-03 or in combination with Sintilimab injectiont
The registry describes a treatment programme. Individual components, doses and actual administration are not established by this entry.
View registry recordSun Yat-Sen University Cancer Center
Guanzhou, Guangdong, China
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.
Ruihua Xu, MD
Sun Yat-sen University
First Submitted
January 31, 2023
First Posted
March 23, 2023
Study Start
March 6, 2022
Actual (reported)Primary Completion
June 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
A Study of KM602 in Patients With Advanced Solid Tumors
Contact the study team to confirm eligibility.
Study Completion
December 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 21, 2023
Record last verified: 2023-03
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Source: ClinicalTrials.gov.
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