RecruitingPhase 1Phase 2NCT05142592

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

A Phase 1/2a, Multi-center, Non-randomized, Open-label, Dose-escalation, and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of IPG7236 Administered Orally as a Single Agent in Patients With Advanced Solid Tumors


Sponsor

Nanjing Immunophage Biotech Co., Ltd

Enrollment

196 participants

Start Date

Nov 15, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 1/2a study is testing a new oral cancer drug called IPG7236 in people with advanced solid tumors that have not responded to standard treatments. IPG7236 is a targeted therapy taken as a pill. The first part of the study tests different doses to find the safest and most effective amount; the second part focuses on specific cancer types including kidney cancer, triple-negative breast cancer, head and neck cancer, and melanoma. You may be eligible if: - You are 18 years of age or older - You have an advanced or metastatic solid tumor confirmed by biopsy or cytology - Your cancer has progressed or you are not eligible for standard treatments - You have at least one measurable tumor on imaging - You have a life expectancy of at least 3 months - Your ECOG performance status is 0 or 1 - You can swallow pills - Your blood counts, kidney, and liver function are adequate You may NOT be eligible if: - You have cancer of the brain or spinal cord as the primary site - You have active hepatitis B or C, or HIV infection - You are pregnant or breastfeeding - You have received recent chemotherapy, immunotherapy, or other anti-cancer drugs (within specified time periods) - You have a prolonged QT interval on your ECG - You have a serious uncontrolled illness - You have had a prior malignancy within the last 3 years (with some exceptions) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIPG7236

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


Locations(7)

Providence Portland Medical Center

Portland, Oregon, United States

NEXT Oncology

Austin, Texas, United States

The First Affiliated Hospital Nanchang Univeristy

Nanchang, Jiangxi, China

Shandong Cancer Hospital

Jinan, Shangdong, China

Shanghai East Hospital

Shanghai, China

Shanghai General Hospital

Shanghai, China

Shanghai GoBroad Cancer Hospital China Pharmaceutical University

Shanghai, China

View Full Details on ClinicalTrials.gov

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NCT05142592


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