Phase1/2a Study for IPG7236 in Patients With Advanced Solid Tumors

Part of paid clinical trials in Portland, Oregon.

Sponsor
Nanjing Immunophage Biotech Co., Ltd
Study ID
NCT05142592
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Pharmacokinetics
  • Safety Issues
  • Tolerability

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IPG7236 — DRUG
    The IPG7236 drug product is supplied as oral tablet dosage form, containing two strengths: 25 mg and 100 mg, respectively, which contain IPG7236.

Study Details

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.

Key Dates

Start date
Nov 15, 2021
Status verified
Mar 2025
Primary completion
Sep 21, 2025
Completion
Dec 21, 2025

Study Design

Enrollment
196 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    1\~6 subjects in this cohort will receive IPG7236 50 mg bid orally.
  • Experimental: Cohort 2
    3\~6 subjects in this cohort will receive IPG7236 100 mg bid orally.
  • Experimental: Cohort 3
    3\~6 subjects in this cohort will receive IPG7236 150 mg bid orally.
  • Experimental: Cohort 4
    3\~6 subjects in this cohort will receive IPG7236 200 mg bid orally.
  • Experimental: Cohort 5
    3\~6 subjects in this cohort will receive IPG7236 250 mg bid orally.
  • Experimental: Cohort 6
    3\~6 subjects in this cohort will receive IPG7236 300 mg bid orally.

Primary Outcome Measure

Occurrence of all adverse events [ Time Frame: Up to 33 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Providence Portland Medical CenterPortlandOregon97222
Rachel Sanborn
NEXT OncologyAustinTexas12221
Andrae Vandross, MD

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