Phase I/II Study of IPG1094 in Advanced Solid Tumors Patients
ConditionSolid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNanjing Immunophage Biotech Co., Ltd
About this trial
This is a phase 1, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) characteristics and initial anti-tumor activity of IPG1094 in patients with advanced solid tumors. The study will be conducted in two parts: dose escalation phase (Part A) and expansion phase (Part B).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female aged ≥ 18 years.
Subjects must have failed or have been intolerant to established standard therapies, or standard therapies did not exist or were no longer effective for a given tumor type, or in the opinion of the investigator have been considered ineligible for a particular form of standard therapy on medical grounds.
Subjects must have at least one evaluable lesion according to RECIST v1.1.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
Disqualifiers
Subjects who received anti-tumor therapy (except for mitomycin, nitrosourea, and fluorouracil oral drugs) within 4 weeks before the first dose, including but not limited to chemotherapy, radiotherapy (palliative radiotherapy is completed at least 2 weeks before the first dose can be enrolled), targeted therapy or immunotherapy.
Subjects who have previous toxicity of anti-tumor therapy that has not been returned to level 0 or 1. (Alopecia, chemotherapy-induced peripheral neurotoxicity and ototoxicity ≤ Grade 2 can be enrolled).
Subjects who received CYP3A4 strong inhibitors or CYP3A4 strong inducers (see https://drug-interactions.medicine.iu.edu/MainTable.aspx) within 14 days prior to the first dose and the subjects who need to continue using these drugs throughout the study.
Subjects who received clinical intervention for biliary obstruction 14 days prior to the first dose or the investigator judges that the symptoms had not resolved or required anti-infective treatment.
Trial design
Design model
Parallel
Treatments tested in this trial
IPG1094
DrugIPG1094 Activity: An inhibitor of macrophage migration inhibitory factor (MIF) Dosage form: Tablet Strength: 50 mg and 100 mg
Treatment groups
60 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Cohort 1 (200 mg BID)Experimental treatment 1 intervention
Group B: Cohort 2 (250 mg BID)Experimental treatment 1 intervention
Group C: Cohort 3 (NSCLC)Experimental treatment 1 intervention
Group D: Cohort 4 (TNBC)Experimental treatment 1 intervention
Group E: Cohort 5 (head and neck cancer)Experimental treatment 1 intervention
Group F: Cohort 6 (brain glioma)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary endpoint
Safety (AE occured over grade 3 in Subjects)
Time frame
Up to 6 months2
Primary endpoint
Tolerability (AE occured over grade 3 in Subjects)
Time frame
Up to 2 months3
Primary endpoint
maximum tolerated dose (MTD)
Time frame
Up to 3 months4
Primary endpoint
recommended phase 2 dose (RP2D)
Time frame
Up to 8 monthsSecondary outcomes
1
Secondary endpoint 1
Pharmacokinetic of IPG1094: Maximum Plasma Concentration \[Cmax\], etc,
Time frame
Up to 6-8 months2
Secondary endpoint 2
Anti-tumor activity of IPG1094: RECIST 1.1 evaluation
Time frame
Up to 6-8 monthsSponsors and contacts
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Source ClinicalTrials.gov