IMX-110 in Patients With Advanced Solid Tumors

• ClinicalTrials.gov Identifier: NCT03382340
• Recruitment Status: Active, not recruiting
• First Posted: December 22, 2017
• Last Update Posted: September 28, 2023
• Sponsor: Immix Biopharma Australia Pty Ltd
• Information provided by (Responsible Party): Immix Biopharma, Inc. ( Immix Biopharma Australia Pty Ltd )

Tracking Information

• First Submitted Date: December 15, 2017
• First Posted Date: December 22, 2017
• Last Update Posted Date: September 28, 2023
• Actual Study Start Date: February 15, 2018
• Estimated Primary Completion Date: October 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 18, 2017)

• Number of participants with treatment-related adverse events assessed by CTCAE v4.03. [ Time Frame: 28 days ]
• Maximum tolerated dose (MTD) of IMX-110 in patients with advanced solid tumors for evaluation in Phase 2a. [ Time Frame: 28 days ]
  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.
• Recommended Phase 2 Dose (RP2D) of IMX-110 in patients with advanced solid tumors [ Time Frame: 28 days ]
  RP2D is defined as one dose level below MTD

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 18, 2017)

• Plasma concentrations of IMX-110 [ Time Frame: 5 days ]
  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).
• Response Rate [ Time Frame: 8 weeks ]
  Objective Response Rate as determined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1.
• Progression-free survival (PFS) [ Time Frame: 5 years ]
  PFS is measured from the start of treatment to the time of progression or death, whichever occurs first while on the study.
• Overall Survival (OS) [ Time Frame: 5 years ]
  OS is defined as the time from Cycle 1 Day1 to death due to any cause.
• Duration of Response (DOR) [ Time Frame: 5 years ]
  DOR as determined by RECIST criteria version 1.1.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures (submitted: December 18, 2017): Pharmacodynamic activity of IMX-110 with appropriate biomarkers. [ Time Frame: Baseline and the end of Cycle 1 (each cycle is 28 days) ]
• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: IMX-110 in Patients With Advanced Solid Tumors
• Official 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Solid Tumor, Adult
• Advanced Solid Tumors
• Pancreatic Cancer
• Breast Cancer
• Ovarian Cancer

Intervention

Drug: Imx-110

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

Study Arms

Experimental: Imx-110

Intervention: Drug: Imx-110

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: December 18, 2017): 70
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2023
• Estimated Primary Completion Date: October 31, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, United States

Administrative Information

• NCT Number: NCT03382340
• Other Study ID Numbers: IMX-110-001
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Immix Biopharma, Inc. ( Immix Biopharma Australia Pty Ltd )
• Original Responsible Party: Immix Biopharma, Inc.
• Current Study Sponsor: Immix Biopharma Australia Pty Ltd
• Original Study Sponsor: Immix Biopharma, Inc.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Immix Biopharma, Inc.
• Verification Date: September 2023