Status:
UNKNOWN
IMX-110 in Patients With Advanced Solid Tumors
Lead Sponsor:
Immix Biopharma Australia Pty Ltd
Conditions:
Solid Tumor, Adult
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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. Th...
Eligibility Criteria
Inclusion
- 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
- IUD (Intrauterine Device)
- Birth control patch (e.g. Ortho Evra)
- NuvaRing®
- 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
- 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.
Key Trial Info
Start Date :
February 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03382340
Start Date
February 15 2018
End Date
December 31 2023
Last Update
September 28 2023
Active Locations (2)
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1
Sarcoma Oncology Research Center
Santa Monica, California, United States, 90403
2
St George Hospital
Sydney, New South Wales, Australia, QLD 4487