Phase I/II Study of IPG1094 in Advanced Solid Tumors Patients

Solid Tumor Clinical Trial

Official title: A Phase I/II, Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic Characteristics and Initial Anti-tumor Activity of IPG1094 in Patients With Advanced Solid Tumors

Status Not yet recruiting

Clinical Trial Summary

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).

Clinical Trial Description

Part A:

In this phase, dose escalation will start from 200 mg and the present 2 dose cohorts are 200 mg BID and 250 mg BID. Up to 12 subjects are expected to be enrolled in this part. In each cohort, all subjects will receive a single oral dose of IPG1094, followed by a 3-day single-dose PK study period. If no significant toxicity occurs, subjects will receive consecutive daily doses (QD, 28 days/cycle) until disease progression, death, unacceptable toxicity, or withdrawal of informed consent (whichever comes first). The DLT evaluation period includes the single-dose PK study period and the first cycle of treatment (within 31 days after the first dose). The remaining subjects within the same cohort will be dosed if no significant safety signals are identified in the first subject in 3 days.

Starting at 200 mg cohort, 3 subjects will be enrolled initially at each subsequent dose cohort in accordance with the 3+3 dose-escalation design. After 3 subjects in each cohort completed DLT evaluation, the Safety Monitoring Committee (SMC) will review all available safety and PK/PD data from all treated subjects (DLT evaluable and non-DLT evaluable subjects), taking into consideration the dose-assignment recommendation based on 3+3 decision rule (as described in the table below), to make the recommendation on the conduct of the study including the dose level and dose schedule for subsequent subjects.

Part B:

After all subjects in Part A completed DLT evaluations, the SMC will review all available safety, PK/PD and efficacy data from all treated subjects, to recommend 1 dose level for Part B. Phase B is an expansion study to evaluate the anti-tumor efficacy and safety of IPG1094 in patients with several types of solid tumors, including but not limited to small cell lung cancer, triple-negative breast cancer, head and neck cancer, and melanoma (specific tumor types will depend on the results of Part A), with 12 subjects in each cohort. A sparse sampling approach for PK with 3 to 4 time points on Day 1 and 3 to 4 time points on Day 28 of Cycle 1, and pre-dose on Day 1 of Cycle 2 and every other cycle thereafter (for example, C4D1, C6D1, C8D1) to allow for population PK and exposure-response (efficacy and safety endpoints) analyses.

Subjects will receive consecutive doses (at the recommended schedule, 28 days/cycle) until disease progression, death, unacceptable toxicity, or withdrawal of informed consent (whichever comes first).

The RP2D will be established by taking into consideration of the PK/PD profiles, safety and efficacy data from both Part A and Part B.

The anti-tumor activity will be evaluated according to the response evaluation criteria in solid tumors version 1.1 (RECIST v1.1). Efficacy assessments will be performed at the screening (within 28 days prior to first administration) and every 2 cycles (8 weeks±7 days) until disease progression, death, withdrawal of informed consent, or study discontinuation. Subjects who discontinue treatment for reasons other than disease progression or death should continue with imaging assessments per protocol-defined schedule until disease progression, death, starting new anti-tumor therapies or withdrawal of informed consent, whichever occurs first. Subjects may be contacted via phone for vital status every 3 months post the last dose until death, withdrawal of informed consent, loss to follow-up or study discontinuation. ;

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

• NCT number: NCT06212076
• Study type: Interventional
• Source: Nanjing Immunophage Biotech Co., Ltd
• Contact: Albert Gao, Master
• Phone: +8613636666256
• Email: ygao@immunophage.com.cn
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: February 20, 2024
• Completion date: August 15, 2024