A Phase 1 interventional study of RC48-ADC and RC98 in Gastric Cancer, sponsored by RemeGen Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-12-18.
Sponsored by RemeGen Co., Ltd. · Phase 1, Interventional, and Treatment
This is a single-center, open-label, dose-escalation phase I clinical study.This study aimed to evaluate the safety, tolerability, pharmacokinetics and preliminary clinical efficacy of RC48-ADC combined with RC98 in subjects with advanced gastric cancer.Which will provide a reference basis for dose confirmation in subsequent clinical studies.
The dose escalation phase will enroll subjects with HER2-expressing locally advanced or metastatic gastric cancer, including gastroesophageal junction adenocarcinoma. HER2 expression is defined as follows (meets one of the following):
The dose-escalation phase preset doses for this combination therapy are as follows:
RC48-ADC: 2.5mg/kg Q2W; RC98 increasing dose: 5.0mg/kg Q2W, 10.0mg/kg Q2W, 15.0mg/kg Q2W. The dose escalation phase of the combination therapy adopts the Bayesian optimal interval (BOIN) design method: the fixed dose of RC48-ADC is 2.5 mg/kg, and the dose of RC98 is escalated, and the initial incremental dose of RC98 is 5.0 mg/kg. MTD has a target toxicity rate of 0.3 and a maximum sample size of 24. The subjects will be enrolled in units of 3, with a maximum of 12 subjects in each dose group; the 28 days after the first dose will be used as the observation window of DLT to make decisions such as dose increase and decrease. If the DLT criteria were not met within 28 days after the first dose, dose escalation was not continued to observe DLT and MTD. After the dose escalation period is over, the investigator decides the recommended phase 2 dose (RP2D) based on the available safety, tolerability, PK, and efficacy information.
After completing the dose-limiting toxicity (DLT) evaluation, the subject can continue to receive the original dose of study drug treatment (but not more than the currently ongoing escalating dose or the maximum tolerated dose under the condition that the investigator judges that there may be benefits) ), subjects received treatment until intolerable toxicity, disease progression, or termination of the study by the sponsor.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's planned enrollment of 24 is below the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →RemeGen Co., Ltd. is the lead sponsor of 77 studies on the registry; 37 are open to participants now.
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Adequate organ and bone marrow hematopoiesis 8. Bone marrow function:
Exclusion Criteria:
Drug: RC48-ADC · Drug: RC98
RC48 for injection is a novel antibody-drug conjugate, with a her-2-targeting antibody and a microtube inhibitor
Also known as: RC48-ADC injection
RC98 is a recombinant humanized IgG1 monoclonal antibody targeting programmed cell death-Ligand 1 (PD-L1)
Also known as: RC98 injection
Dose limiting toxicity (DLT)
In the DLT evaluation window (observation period 1-28 days after the first administration), according to the NCI-CTCAE v5.0 grading standard, the investigator or the sponsor believes that toxic reaction which are reasonably related to RC48 and/or RC98 treatment
Time frame: 28 days after first treatment
The incidence and severity of adverse events (AE)
Adverse events was assessed by investigator(s) according to NCI-CTCAE v5.0
Time frame: From the day of ICF sign to 28 days after the day of the last treatment
Cmax of RC48
Peak Plasma Concentration of RC48
Time frame: 24 months
AUC of RC48
Area under the plasma concentration versus time curve of RC48
Time frame: 24 months
Cmax of RC98
Peak Plasma Concentration of RC98
Time frame: 24 months
AUC of RC98
Area under the plasma concentration versus time curve of RC98
Time frame: 24 months
AUC of MMAE
Area under the plasma concentration versus time curve of MMAE
Time frame: 24 months
Cmax of MMAE
Peak Plasma Concentration of MMAE
Time frame: 24 months
Immunogenicity of RC48
Anti-drug antibody (ADA) of RC48 positive samples, etc.
Time frame: 24 months
Immunogenicity of RC98
Anti-drug antibody (ADA) of RC98 positive samples, etc.
Time frame: 24 months
Objective response rate (ORR)
Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)
Time frame: 24 months
Duration of Remission (DOR)
Duration of response is the length of time that a tumor continues to respond to treatment without the cancer growing or spreading
Time frame: 24 months
Disease Control Rate(DCR)
Proportion of patients whose tumors shrank or stabilized for a certain period of time
Time frame: 24 months
Progression-free survival
Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time frame: 24 months
Plan to share: No
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RemeGen Co., Ltd.