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

NCT05142592 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2025-09-24

No results posted yet for this study

Summary

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.

Conditions

  • Safety Issues
  • Tolerability
  • Pharmacokinetics

Interventions

DRUG

IPG7236

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

Sponsors & Collaborators

  • Nanjing Immunophage Biotech Co., Ltd

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-15
Primary Completion
2025-09-21
Completion
2025-12-21
FDA Drug
Yes

Countries

  • United States
  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05142592 on ClinicalTrials.gov