A First-in-Human Escalation and Expansion Study of Patients With Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJiaRay Group
About this trial
The goal of this clinical trial is to learn if the investigational drug (JR8603) is safe and effective in treating patients with solid tumors after their initial rounds of treatment with other drugs did not work.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥18 years of age.
Histologically confirmed, locally advanced, or metastatic solid tumor which has progressed on, or patients intolerant to, all standard therapy, or no standard therapy available, or it is documented that the therapy is refused by the patient.
Measurable disease per RECIST v1.1.
Life expectancy ≥3 months.
Disqualifiers
Any condition that in the opinion of the Investigator would place the patient at an unacceptable risk or cause the patient to be unlikely to fully participate or comply with study procedures.
Received systemic anticancer chemotherapy, targeted agents, antibody therapy for cancer, immunotherapy for cancer, hormonal therapy, or an investigational agent within 2 weeks or 5 half-lives (whichever is shorter) prior to start of study drug treatment.
Major surgery within 3 weeks prior to start of study drug treatment.
Radiation therapy within 4 weeks prior to start of study drug treatment (palliative radiation or stereotactic radiosurgery within 7 days prior to start of study drug treatment). Patients must have recovered from all acute radiotherapy-related toxicities.
Trial design
Design model
Sequential
Treatments tested in this trial
JR8603
DrugIV infusion on Days 1, 8, and 15 of continuous 28-day cycles
Treatment groups
94 Participants
are divided into 9 treatment groups9
Treatment groupsSee each treatment group below.
Group A: Escalation Cohort - Dose Level -1Experimental treatment 1 intervention
Group B: Escalation Cohort - Dose Level 1Experimental treatment 1 intervention
Group C: Escalation Cohort - Dose Level 2Experimental treatment 1 intervention
Group D: Escalation Cohort - Dose Level 3Experimental treatment 1 intervention
Group E: Escalation Cohort - Dose Level 4Experimental treatment 1 intervention
Group F: Escalation Cohort - Dose Level 5Experimental treatment 1 intervention
Group G: Escalation Cohort - Dose Level 6Experimental treatment 1 intervention
Group H: Expansion Cohort 1Experimental treatment 1 intervention
Group I: Expansion Cohort 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Adverse Events (Including Serious Adverse Events)
The severity of all AEs will be graded according to the NCI CTCAE v5.0 criteria.
Time frame
From study drug administration until 28 (±7) days after the last dose of study drug, up to approximately 1 year2
Dose-Limiting Toxicity (DLT)
Incidence of DLTs
Time frame
From study drug administration until 28 (±7) days after the last dose of study drug, up to approximately 1 year3
Maximum tolerated dose (MTD)
Evaluated based on DLT-Evaluable patients in part 1 Dose Escalation
Time frame
From study drug administration until 28 (±7) days after the last dose of study drug, up to approximately 1 year4
Dose Expansion - to assess preliminary evidence of efficacy for each cohort
Measured by Overall Response Rate (ORR) as defined by RECIST v1.1.
Time frame
From study drug administration until 28 (±7) days after the last dose of study drug, up to approximately 1 yearSecondary outcomes
1
Overall Response Rate (ORR)
Defined as the proportion of patients with a best overall response of confirmed Complete Response (CR) or Partial Response (PR) per RECIST v1.1
Time frame
From study drug administration until 28 (±7) days after the last dose of study drug, up to approximately 1 year2
Assess Plasma concentrations and relevant PK parameters for JR8603 and the active metabolite (mitomycin C)
Will be assessed based on blood samples collected from patients during the study.
Time frame
From study drug administration until 28 (±7) days after the last dose of study drug, up to approximately 1 year3
Time to Response (TTR)
Defined as the time from the date of the first dose to the date at which criteria are first met for Complete Response (CR) or Partial Response (PR) per RECIST v1.1.
Time frame
From study drug administration until 28 (±7) days after the last dose of study drug, up to approximately 1 year4
Duration of Response (DOR)
Defined as the time from the start of the first response (CR or PR) to the first occurrence of progressive disease per RECIST v1.1 or death due to any cause
Time frame
From study drug administration until 28 (±7) days after the last dose of study drug, up to approximately 1 yearSponsors and contacts
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Source ClinicalTrials.gov