NCT03382340

Brief Summary

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2018

Longer than P75 for phase_1

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 22, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

February 15, 2018

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

5.7 years

First QC Date

December 15, 2017

Last Update Submit

September 26, 2023

Conditions

Solid Tumor, AdultAdvanced Solid TumorsPancreatic CancerBreast CancerOvarian Cancer

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (5)

  • Plasma concentrations of IMX-110

    5 days

  • Response Rate

    8 weeks

  • Progression-free survival (PFS)

    5 years

  • Overall Survival (OS)

    5 years

  • Duration of Response (DOR)

    5 years

Other Outcomes (1)

  • Pharmacodynamic activity of IMX-110 with appropriate biomarkers.

    Baseline and the end of Cycle 1 (each cycle is 28 days)

Study Arms (1)

Imx-110

EXPERIMENTAL
Drug: Imx-110

Interventions

Imx-110DRUG

a nanoparticle encapsulating a Stat3/NF-kB/poly-tyrosine kinase inhibitor and low-dose doxorubicin

Imx-110

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • Absolute neutrophil count (ANC) ≥ 1.0 x 10\^9/L
  • Hemoglobin (HGB) ≥ 90.0 g/L (patients may be transfused to achieve this HGB level)
  • Platelet count ≥ 100 x 10\^9/L
  • Total bilirubin level ≤ 1.5 x ULN
  • AST and ALT ≤ 2.5 x ULN (≤5 x ULN if liver metastasis present)
  • Creatinine ≤ 1.5 x ULN (Creatinine clearance \>50 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal)
  • 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:
  • Birth control pills (The Pill)
  • Depot or injectable birth control
  • +7 more criteria

You may not qualify if:

  • Patients with a history of severe allergic reactions to any unknown allergens or any components of the study drug formulation.
  • Patients receiving any chemotherapy within 14 days of dosing, immunotherapy within 28 days of dosing, or biologic or hormonal therapy within 28 days of dosing for cancer treatment. Patients with prostate cancer can continue administration of Gonadotropin-releasing hormone (GnRH) agonists.
  • Subject participating in any other drug study ≤ 4 weeks (6 weeks for immunotherapy investigational agents) or 5 half-lives of the investigational product, whichever is longer, prior to study drug administration or is scheduled to receive one during the treatment or post-treatment period.
  • Patients who have reached their life time limit of DOX or who are anticipated to reach their lifetime limit (550 mg/m2) within the first 2 cycles of IMX-110 administration.
  • Patients who are expected to need surgery or benefit from other anti-cancer therapy to be initiated during the study period.
  • Patients with a history of and/or risk factors for ischemic heart disease, congestive heart failure, symptomatic bradycardia, atrioventricular (AV) block, prolonged QTcF interval (\>450 msec in men and \>470 msec in women and additional risk factors for QT prolongation (e.g. hyperthyroidism, electrolyte imbalance).
  • Patients who have not recovered from adverse events (AEs; ≥ CTCAE grade 2) due to prior treatment (i.e. chemotherapy, targeted therapy, radiation, or surgery) within 7 days prior to Cycle 1 Day 1, unless deemed to be irreversible, or approved by the Sponsor and Medical Monitor.
  • Females who are pregnant or lactating or intend to become pregnant before, during, or within 24 weeks after participating in this study; or intending to donate ova during such time period.
  • Patients with a known positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C antibodies (HCV). Patients may be enrolled if they have HBV or HCV with viral load suppressed by anti-virals.
  • Any condition that, in the opinion of the investigator or sponsor, would interfere with evaluation of the investigational product.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sarcoma Oncology Research Center

Santa Monica, California, 90403, United States

Location

St George Hospital

Sydney, New South Wales, QLD 4487, Australia

Location

MeSH Terms

Conditions

Pancreatic NeoplasmsBreast NeoplasmsOvarian Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesGonadal Disorders

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2017

First Posted

December 22, 2017

Study Start

February 15, 2018

Primary Completion

October 31, 2023

Study Completion

December 31, 2023

Last Updated

September 28, 2023

Record last verified: 2023-09

Locations

AU(1)US(1)