A Phase 1/2 interventional study of SHR2150 and Anti-Cancer Agent in Solid Tumor, sponsored by Chinese PLA General Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-10-19.
Sponsored by Chinese PLA General Hospital · Phase 1/2, Interventional, and Treatment
This phase I/II trial aims to evaluate safety and efficacy of SHR2150 in combination with chemotherapy plus PD-1 or CD47 antibody in subjects with unresectable/ metastatic solid tumors. Patients will receive the combined regimen in 3-week treatment cycles. During the Phase 1 dose escalation portion of the trial, three oral doses of SHR2150 will be combined with intravenous administration of chemotherapy and PD-1 or CD47 antibody. In the Phase 2 dose expansion portion, patients will be treated with the Recommended Phase 2 Dose (RP2D) of SHR2150 in combination with chemotherapy plus PD-1 or CD47 antibody.
Identification of T cell inhibitory signals, including PD-1/L1, has prompted the development of a new class of cancer immunotherapy that could restore an adequate immunosurveillance against the neoplasm and enhance T-cell-mediated anticancer immune responses. However, elimination of cancer by T cells is only one step in the cancer-immunity cycle, which enable providing several therapeutic targets and tailoring of combinations of immune therapies. SHR2150 is a small molecule agonist of toll-like receptors (TLRs) 7 designed to activate antigen-presenting cells and functions as mucosal immunoadjuvants in pre-clinical studies. This study is a first-in-man, Phase I/II, dose escalation/expansion study of a combined regimen of SHR2150 in combination with chemotherapy plus PD-1 or CD47 antibody in subjects with unresectable/ metastatic solid tumors. This study is designed to assess the safety, tolerability, RP2D and clinical efficacy of this regimen.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 50 is close to the median of 50 across 7,253 interventional studies indexed under Neoplasms.
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Exclusion Criteria:
With a standard 3+3 dose escalation design, the enrollment will proceed until the MTD has been defined or the highest dose level has been reached.
Drug: SHR2150 · Drug: Anti-Cancer Agent
SHR2150 RP2D will be combined with chemotherapy plus PD-1 or CD47 antibody in 3-week treatment cycles.
Drug: Anti-Cancer Agent · Drug: SHR2150
Patients will receive escalating doses of SHR-2150 (starting dose 2 mg) in 3-week treatment cycles.
The previously resistant first-line cytotoxic regimens, anti-PD-1 antibody and/or anti-CD47 antibody will be administered intravenously Q3W.
Patients will receive SHR-2150 at RP2D in 3-week treatment cycles.
Safety of the combined regimen of SHR2150, chemotherapy, PD-1 or CD47 antibody
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0. AEs were considered to be treatment-related if they had started or worsened within the interval from first study drug administration until the follow-up visit.
Time frame: 60 days after last dose
Identify a RP2D of SHR2150 when given in combined regimen
The Recommended Phase 2 Dose (RP2D) of SHR2150 in the combined regimen will be identified at Phase 1 dose escalation period, and will be used in the phase 2 dose expansion period.
Time frame: 30 days
Object response rate (ORR)
ORR is defined as the proportion of subjects who achieved a partial response (PR) or complete response (CR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame: 24 month
Disease control rate (DCR)
DCR is defined as the proportion of subjects who achieved a stable disease (SD), partial response (PR) or complete response (CR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame: 24 months
Progression-free survival (PFS)
PFS was measured from study entry to the first documentation of disease progression or death. Disease progression was determined per the RECIST V1.1.
Time frame: 24 months
Duration of Response (DOR)
DOR is defined as the time from the date of first documented response that is subsequently confirmed until date of documented progression or death in the absence of disease progression, the end of response should coincide with the date of progression or death from any cause used for the PFS endpoint. If the disease does not progress after a response, their duration of response will use the PFS censoring time.
Time frame: 24 months
Overall survival (OS)
OS was measured from the study entry to the date of death.
Time frame: 24 months
Time to Response (TTR)
TTR is defined as the period from the date of first dose to the date of the first evaluated response of CR or PR. If the response is not confirmed, it will not be included.
Time frame: 6 months
Number of participants with laboratory test abnormalities
The bead-based immunoassay of serum cytokines and chemokines, such as IFN-α/β/γ, IL-6 and so on, will be performed on day 1 and 3 of each cycle, and the abnormality will be determined by the investigator.
Time frame: Approximately 6 months
Number of participants with pathological immunology marker change
Tumor tissues will be collected by biopsy at baseline and specified time points for all subjects. Tumor samples were analyzed by immunohistochemical pathological analysis and multiplex immunostaining.
Time frame: Approximately 6 months
Plan to share: Undecided
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Chinese PLA General Hospital