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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03382340
Ethics application status
Date submitted
15/12/2017
Date registered
18/12/2017
Date last updated
27/02/2018

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
Cancer 0 0 0 0
Pancreatic

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. - 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.
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 - RP2D is defined as one dose level below MTD
Timepoint [3] 0 0
28 days
Secondary outcome [1] 0 0
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).
Timepoint [1] 0 0
5 days
Secondary outcome [2] 0 0
Response Rate - Objective Response Rate as determined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1.
Timepoint [2] 0 0
8 weeks
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
5 years
Secondary outcome [4] 0 0
Overall Survival (OS) - OS is defined as the time from Cycle 1 Day1 to death due to any cause.
Timepoint [4] 0 0
5 years
Secondary outcome [5] 0 0
Duration of Response (DOR) - DOR as determined by RECIST criteria version 1.1.
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
Gender
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
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/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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

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/show/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
Ilya Rachman, MD
Address 0 0
Country 0 0
Phone 0 0
888-958-1084
Fax 0 0
Email 0 0
info@immixbio.com
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Not applicable