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

NCT06212076 | Recruiting Phase 1

• 1 other identifier: IPG1094-C002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (4)

• Primary endpoint

  Safety (AE occured over grade 3 in Subjects)

  Up to 6 months

• Primary endpoint

  Tolerability (AE occured over grade 3 in Subjects)

  Up to 2 months

• Primary endpoint

  maximum tolerated dose (MTD)

  Up to 3 months

• Primary endpoint

  recommended phase 2 dose (RP2D)

  Up to 8 months

Secondary Outcomes (2)

• Secondary endpoint 1

  Up to 6-8 months

• Secondary endpoint 2

  Up to 6-8 months

Study Arms (6)

Cohort 1 (200 mg BID)

EXPERIMENTAL

Starting at 200mg BID cohort, 3 subjects will be enrolled. After 3 subjects 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 , to make the recommendation on the conduct of the study including the dose level and dose schedule for subsequent subjects.

Drug: IPG1094

Cohort 2 (250 mg BID)

EXPERIMENTAL

Starting at 250 mg BID cohort, 3 subjects will be enrolled. After 3 subjects 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 , to make the recommendation on the conduct of the study including the dose level and dose schedule for subsequent subjects.

Drug: IPG1094

Cohort 3 (NSCLC)

EXPERIMENTAL

Phase B is an expansion study to evaluate the anti-tumor efficacy and safety of IPG1094 in patients with non small cell lung cancer (specific tumor types will depend on the results of Part A), with 12 subjects enrolled. 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.

Drug: IPG1094

Cohort 4 (TNBC)

EXPERIMENTAL

Phase B is an expansion study to evaluate the anti-tumor efficacy and safety of IPG1094 in patients with triple-negative breast cancer (specific tumor types will depend on the results of Part A), with 12 subjects enrolled. 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.

Drug: IPG1094

Cohort 5 (head and neck cancer)

EXPERIMENTAL

Phase B is an expansion study to evaluate the anti-tumor efficacy and safety of IPG1094 in patients with head and neck cancer (specific tumor types will depend on the results of Part A), with 12 subjects enrolled. 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.

Drug: IPG1094

Cohort 6 (brain glioma)

EXPERIMENTAL

Phase B is an expansion study to evaluate the anti-tumor efficacy and safety of IPG1094 in patients with brain glioma (specific tumor types will depend on the results of Part A), with 12 subjects enrolled. 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.

Drug: IPG1094

Interventions

IPG1094 DRUG

IPG1094 Activity: An inhibitor of macrophage migration inhibitory factor (MIF) Dosage form: Tablet Strength: 50 mg and 100 mg

Cohort 1 (200 mg BID); Cohort 2 (250 mg BID); Cohort 3 (NSCLC); Cohort 4 (TNBC); Cohort 5 (head and neck cancer); Cohort 6 (brain glioma)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet all of the following criteria to be included in the study:
• Male or female aged ≥ 18 years.
• In Part A:
• Subjects must have a histological diagnosis of locally advanced or metastatic malignant solid tumors, and that is not amenable to curative surgical and/or locoregional therapies;
• In Part B:
• Subjects must have a histological diagnosis of locally advanced or metastatic malignant solid tumors, and that is not amenable to curative surgical and/or locoregional therapies (tumor types in Part B will include but not limited to small cell lung cancer, triple-negative breast cancer, head and neck cancer, and melanoma).
• Subjects must have failed or have been intolerant to established standard therapies, or standard therapies did not exist or were no longer effective for a given tumor type, or in the opinion of the investigator have been considered ineligible for a particular form of standard therapy on medical grounds.
• Subjects must have at least one evaluable lesion according to RECIST v1.1.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
• Life expectancy ≥ 12 weeks.
• Subjects must have adequate organ and bone marrow function (no hematopoietic growth factor, blood transfusion, or platelet therapy within 2 weeks before the screening and during the screening):
• Complete blood count (CBC): neutrophils ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L, hemoglobin ≥ 9.0 g/dL.
• Liver function: total bilirubin ≤ 1.5 × ULN; ALT/AST ≤ 2.5 × ULN without liver metastasis; ALT/AST ≤ 5 × ULN with liver metastasis;
• Coagulation: International normalized ratio (INR) ≤ 1.5 × ULN and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (for patients undergoing anticoagulant therapy. The investigator will judge that the INR and APTT are within a safe treatment range);
• Renal function: creatinine clearance \> 50 mL/min (calculated using the Cockcroft-Gault formula) in the condition of creatinine level \> ULN; urine protein qualitative ≤ 1 + (if ≥ 2+, 24 hours of urine protein test is required, if 24 hours urine protein \<1 g, then allowed to enroll);

You may not qualify if:

• Subjects who meet any of the following criteria will be excluded from the study:
• Subjects who received anti-tumor therapy (except for mitomycin, nitrosourea, and fluorouracil oral drugs) within 4 weeks before the first dose, including but not limited to chemotherapy, radiotherapy (palliative radiotherapy is completed at least 2 weeks before the first dose can be enrolled), targeted therapy or immunotherapy.
• Note: Mitomycin and nitrosourea have been treated within 6 weeks after the last dose; oral fluorouracil such as tegafur and capecitabine has been treated within 2 weeks after the last dose.
• Subjects who have previous toxicity of anti-tumor therapy that has not been returned to level 0 or 1. (Alopecia, chemotherapy-induced peripheral neurotoxicity and ototoxicity ≤ Grade 2 can be enrolled).
• Subjects who received CYP3A4 strong inhibitors or CYP3A4 strong inducers (see https://drug-interactions.medicine.iu.edu/MainTable.aspx) within 14 days prior to the first dose and the subjects who need to continue using these drugs throughout the study.
• Subjects who received clinical intervention for biliary obstruction 14 days prior to the first dose or the investigator judges that the symptoms had not resolved or required anti-infective treatment.
• Subjects who had clinically uncontrollable pleural effusion, ascites, or pericardial effusion within 2 weeks prior to the first dose.
• Subjects who have symptomatic brain metastases or spinal cord compression. Subjects who have previously treated for brain metastases, if the clinical condition is stable and imaging evidence does not show disease progression within 4 weeks prior to the first dose and do not need corticosteroid treatment within 2 weeks prior to the first dose, can be enrolled.
• Subjects who have active bacterial or fungal infections (≥ Grade 2) that required systemic treatment within 14 days prior to the first dose.
• Subjects who participated in any other study in which receipt of an investigational new drug, or investigational device occurred within 28 days or 5 half-lives (whichever is shorter) of the first dose of the study drug.
• Receiving systemic steroid therapy (\> 10 mg/day of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study drug.
• Subjects who have a chronic or active infection requiring systemic therapy.
• Subjects who have gastrointestinal disorders that will affect oral administration or the investigator judges that the absorption of IPG1094 will be interfered.
• Known or suspected allergy or hypersensitivity to any component of IPG1094.
• Subjects who received a diagnosis of, and/or tested positive at screening for human immunodeficiency virus (HIV).

Sponsors & Collaborators

• Nanjing Immunophage Biotech Co., Ltd: lead

Study Sites (2)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

RECRUITING

Shanghai GoBroad Cancer Hospital China Pharmaceutical University

Shanghai, China

RECRUITING

Central Study Contacts

Filipe Huang

CONTACT

+8621 34782827; yfhuang@immunophage.com.cn

Yang Hu

CONTACT

+8621 34782827; yhu@immunophage.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2023
• First Posted: January 18, 2024
• Study Start: July 11, 2024
• Primary Completion (Estimated): July 9, 2027
• Study Completion (Estimated): July 9, 2027
• Last Updated: September 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)