Phase1/2a Study for IPG7236 in Patients With Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNanjing Immunophage Biotech Co., Ltd
About this trial
This is a Phase 1/2a first-in-human, multi-center, non-randomized, open-label study to assess the safety, tolerability, pharmacokinetics profile, and preliminary anti-tumor activity of IPG7236 administered orally as a single agent to patients with advanced solid tumors.
The study will include a dose escalation phase (Phase 1) and a dose expansion phase (Phase 2a).
Each part will consist of a screening period of up to 28 days, a treatment period, an end of treatment visit and a safety follow-up of approximately 30 days after the last dose. IPG7236 will be given on an empty stomach (either one hour before or two hours after a meal) twice daily (approximately every 12±1 hours) in continuous 28-day cycles.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
A written informed consent must be signed prior to performing any study procedures.
Male or females 18 years or older.
Diagnosis of advanced or recurrent, histologically or cytologically confirmed, a solid malignancy that is either metastatic or unresectable.
Part 1 Dose Escalation: all solid tumor types.
Disqualifiers
Subjects with primary malignancy of the central nervous system or malignancies related to human immunodeficiency virus (HIV) or solid organ transplant.
Subjects who have not recovered from all toxic effects from prior antitumor therapy or surgical procedures, defined as toxicities (other than alopecia) not yet resolved to Grade ≤ 1 according to NCI CTCAE v5.0.
Subjects with recent prior therapy defined as
Any investigational or Food and Drug Administration (FDA)-approved anti-cancer drug within 14 days or 5 half-lives, whichever is longer, prior to the first dose of study drug.
Trial design
Design model
Parallel
Treatments tested in this trial
IPG7236
DrugThe IPG7236 drug product is supplied as oral tablet dosage form, containing two strengths: 25 mg and 100 mg, respectively, which contain IPG7236.
Treatment groups
196 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Cohort 1Experimental treatment 1 intervention
Group B: Cohort 2Experimental treatment 1 intervention
Group C: Cohort 3Experimental treatment 1 intervention
Group D: Cohort 4Experimental treatment 1 intervention
Group E: Cohort 5Experimental treatment 1 intervention
Group F: Cohort 6Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Occurrence of all adverse events
Evaluation of adverse events
Time frame
Up to 33 days2
Maximum tolerated dose (MTD）
MTD will be defined as the maximum dose level at which no more than 1 of 3 participants experience a dose-limiting toxicity (DLT) within the first 33days of multiple dosing.
Time frame
Up to 33 days3
Phase II dose (RP2D)
The number and proportion of patients experiencing at least 1 dose-limiting toxicity (DLT) will be used as the primary measure to evaluate the RP2D of IPG7236
Time frame
Up to 33 days4
Disease Control Rate(DCR)
Disease Control Rate(DCR) will be determined based on the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time frame
up to 1 year(anticipated)Secondary outcomes
1
Maximum plasma concentration（Cmax）
Pharmacokinetic (PK) parameters after a single oral dose of IPG7236
Time frame
Up to 33 days2
Time to Cmax (tmax)
Pharmacokinetic (PK) parameters after a single oral dose of IPG7236
Time frame
Up to 33 days3
Area under the serum concentration-time curve (AUC[0-t]
Pharmacokinetic (PK) parameters after a single oral dose of IPG7236
Time frame
Up to 33 days4
Area under the serum concentration-infinity curve AUC[0-infinity]
Pharmacokinetic (PK) parameters after a single oral dose of IPG7236
Time frame
Up to 33 daysSponsors and contacts
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Source ClinicalTrials.gov