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Phase 1 is an open-label, multi-center dose escalation/dose expansion study designed to assess the safety, tolerability and pharmacokinetics (PK) for the recommended phase 2 dose (RP2D) of IMX-110. The RP2D will be evaluated in a further dose expansion Phase 2a study submitted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imx-110 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imx-110 | Drug | a nanoparticle encapsulating a Stat3/NF-kB/poly-tyrosine kinase inhibitor and low-dose doxorubicin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events assessed by CTCAE v4.03. | 28 days | |
| Maximum tolerated dose (MTD) of IMX-110 in patients with advanced solid tumors for evaluation in Phase 2a. | The MTD is defined as the highest dose at which ≤ 33% of the patients treated during the 3+3 design experience a DLT and/or at least two ≥ grade 2 toxicities during the first treatment cycle, and will be used to identify the RP2D to be taken forward to Phase 2a. | 28 days |
| Recommended Phase 2 Dose (RP2D) of IMX-110 in patients with advanced solid tumors | RP2D is defined as one dose level below MTD | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations of IMX-110 | Plasma concentrations of IMX-110 will be measured when administered in treatment Cycle 1. Samples will be collected on the first day (pre-dose, 0.5, 1, 2, 4, 6 and 24 hours post-dose) and the 5th day of dosing (pre-dose, 0.5, 1, 2, 4 and 6 hours post-dose). | 5 days |
| Response Rate |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic activity of IMX-110 with appropriate biomarkers. | Baseline and the end of Cycle 1 (each cycle is 28 days) |
Inclusion Criteria:
Male or female patients who are 18 years or older
Patients with confirmed advanced solid tumor as per histology, who have progressed, are refractory, or are intolerant to standard therapy appropriate for tumor type
Patients with an Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2 (Appendix 2)
Patients with a life expectancy of at least 3 months
Patients with adequate cardiac function as measured by left ventricular ejection fraction >50%
Patients who meet the following laboratory requirements:
Women of childbearing potential and men must agree to use highly effective, double barrier contraception during the study and for 6 weeks following the final dose of IMX-110. Double barrier contraception is defined as a condom AND one other form of the following:
Male patients must not donate sperm for at least 24 weeks post-dose of the last study treatment. Male partners of female patients and female partners of male patients must also use contraception, if they are of childbearing potential.
Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1.
Rhythm methods during the study and for 6 weeks after the dose of IMX-110 will not be acceptable.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sarcoma Oncology Research Center | Santa Monica | California | 90403 | United States | ||
| St George Hospital |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D001943 | Breast Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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Objective Response Rate as determined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1. |
| 8 weeks |
| Progression-free survival (PFS) | PFS is measured from the start of treatment to the time of progression or death, whichever occurs first while on the study. | 5 years |
| Overall Survival (OS) | OS is defined as the time from Cycle 1 Day1 to death due to any cause. | 5 years |
| Duration of Response (DOR) | DOR as determined by RECIST criteria version 1.1. | 5 years |
| Sydney |
| New South Wales |
| QLD 4487 |
| Australia |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |