A Pan-RAS Inhibitor in Combination With Anti-Tumor Therapy in Participants With Advanced Pancreatic Cancer
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhejiang University
About this trial
This study aims to evaluate the safety, tolerability, and efficacy of HRS-2329 in combination with other anti-tumor therapies in participants with advanced pancreatic cancer harboring RAS mutations or amplifications.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years.
Histopathologically confirmed locally advanced or metastatic pancreatic adenocarcinoma (originating from pancreatic ductal epithelium) that is not amenable to curative therapy.
RAS mutation or amplification detected in tumor tissue or blood (by RAS testing).
For cohort HRS-2329-A: at least one line of standard systemic therapy in the advanced setting;
Disqualifiers
Prior treatment with drugs similar to the investigational product.
Known presence of central nervous system (CNS) metastases.
Acute or chronic pancreatitis requiring clinical intervention.
Gastrointestinal disorders that may affect drug administration/absorption, including but not limited to dysphagia, malabsorption syndrome, refractory nausea, vomiting, or diarrhea, Crohn's disease, and ulcerative colitis.
Trial design
Design model
Sequential
Treatments tested in this trial
HRS-2329 Tablet
DrugHRS-2329 is a novel, potent, oral pan-RAS inhibitor. HRS-2329 is given orally (to be swallowed whole, not chewed). It should be taken orally within 30 minutes after breakfast each morning.
Nimotuzumab
DrugNimotuzumab is a marketed drug, a recombinant humanized monoclonal antibody targeting the epidermal growth factor receptor (EGFR). Nimotuzumab is administered at 400 mg by intravenous infusion over at least 60 minutes on Days 1 and 8 of each 3-week cycle.
HS-20093
DrugHS-20093 is a B7-H3 antibody-drug conjugate (ADC).
Adebrelimab
DrugAdebrelimab is a recombinant humanized anti-PD-L1 monoclonal antibody injection. It specifically blocks the binding of PD-1 to PD-L1, thereby terminating the immunosuppressive signals transmitted through PD-1 to T cells. This enables T cells to re-recognize tumor cells and exert cytotoxic effects, ultimately inhibiting tumor growth. Adebrelimab injection is administered at 1200 mg by intravenous infusion on Day 1 of each 3-week cycle.
Treatment groups
80 Participants
are divided into 3 treatment groupsGroup A: Arm AExperimental treatment 2 interventions
Group B: Arm BExperimental treatment 3 interventions
Group C: Arm CExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Objective Response Rate
The proportion of patients whose tumor size shrinks as complete response or partial response, as assessed by RECIST1.1.
Time frame
From enrollment to upto 2 yearsSecondary outcomes
1
Disease Control Rate (DCR)
defined as the proportion of patients with advanced or metastatic cancer who have achieved a complete response (CR), partial response (PR), or stable disease (SD) as the best overall response, relative to the total number of evaluable patients.
Time frame
From enrollment to upto 2 years2
Duration of Response
defined as the time from the first documented objective response (Complete Response \[CR\] or Partial Response \[PR\]) to the first documented disease progression (per RECIST 1.1 criteria) or death due to any cause, whichever occurs first.
Time frame
From enrollment to upto 2 years3
Progression-Free Survival
defined as the time from initiation of treatment until the first documented disease progression per RECIST 1.1 criteria, or death due to any cause, whichever occurs first.
Time frame
From enrollment to upto 2 years4
Overall Survival
defined as the time from initiation of treatment until death from any cause.
Time frame
From enrollment to upto 2 yearsSponsors and contacts
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Source ClinicalTrials.gov
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