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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03382340




Registration number
NCT03382340
Ethics application status
Date submitted
15/12/2017
Date registered
22/12/2017
Date last updated
28/09/2023

Titles & IDs
Public title
IMX-110 in Patients With Advanced Solid Tumors
Scientific title
A Phase 1/2a Open-Label, Dose-Escalation/Dose-Expansion Safety, Tolerability and Pharmacokinetic Study of IMX-110 in Patients With Advanced Solid Tumors
Secondary ID [1] 0 0
IMX-110-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumor, Adult 0 0
Advanced Solid Tumors 0 0
Pancreatic Cancer 0 0
Breast Cancer 0 0
Ovarian Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Imx-110

Experimental: Imx-110 -


Treatment: Drugs: Imx-110
a nanoparticle encapsulating a Stat3/NF-kB/poly-tyrosine kinase inhibitor and low-dose doxorubicin
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with treatment-related adverse events assessed by CTCAE v4.03.
Timepoint [1] 0 0
28 days
Primary outcome [2] 0 0
Maximum tolerated dose (MTD) of IMX-110 in patients with advanced solid tumors for evaluation in Phase 2a.
Timepoint [2] 0 0
28 days
Primary outcome [3] 0 0
Recommended Phase 2 Dose (RP2D) of IMX-110 in patients with advanced solid tumors
Timepoint [3] 0 0
28 days
Secondary outcome [1] 0 0
Plasma concentrations of IMX-110
Timepoint [1] 0 0
5 days
Secondary outcome [2] 0 0
Response Rate
Timepoint [2] 0 0
8 weeks
Secondary outcome [3] 0 0
Progression-free survival (PFS)
Timepoint [3] 0 0
5 years
Secondary outcome [4] 0 0
Overall Survival (OS)
Timepoint [4] 0 0
5 years
Secondary outcome [5] 0 0
Duration of Response (DOR)
Timepoint [5] 0 0
5 years

Eligibility
Key inclusion criteria
1. Male or female patients who are 18 years or older
2. Patients with confirmed advanced solid tumor as per histology, who have progressed, are refractory, or are intolerant to standard therapy appropriate for tumor type
3. Patients with an Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2 (Appendix 2)
4. Patients with a life expectancy of at least 3 months
5. Patients with adequate cardiac function as measured by left ventricular ejection fraction >50%
6. Patients who meet the following laboratory requirements:

1. Absolute neutrophil count (ANC) = 1.0 x 10^9/L
2. Hemoglobin (HGB) = 90.0 g/L (patients may be transfused to achieve this HGB level)
3. Platelet count = 100 x 10^9/L
4. Total bilirubin level = 1.5 x ULN
5. AST and ALT = 2.5 x ULN (=5 x ULN if liver metastasis present)
6. Creatinine = 1.5 x ULN (Creatinine clearance >50 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal)
7. 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:

1. Birth control pills (The Pill)
2. Depot or injectable birth control
3. IUD (Intrauterine Device)
4. Birth control patch (e.g. Ortho Evra)
5. NuvaRing®
6. Documented evidence of surgical sterilization at least 6 months prior to the screening visit, i.e., tubal ligation or hysterectomy for women or vasectomy for men.

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with a history of severe allergic reactions to any unknown allergens or any components of the study drug formulation.
2. 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.
3. 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.
4. 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.
5. Patients who are expected to need surgery or benefit from other anti-cancer therapy to be initiated during the study period.
6. 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).
7. 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.
8. 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.
9. 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.
10. Any condition that, in the opinion of the investigator or sponsor, would interfere with evaluation of the investigational product.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/02/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St George Hospital - Sydney
Recruitment postcode(s) [1] 0 0
QLD 4487 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Immix Biopharma Australia Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT03382340
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03382340