Malignant Solid Tumour
Conditions
Keywords
INNO-206, Phase 1, DOXO-EMCH, Advanced solid tumors
Brief summary
This is a phase 1b open-label study evaluating the preliminary safety and maximum tolerated dose of a new formulation of INNO-206 administered at doses of 230 mg/m2, 350 mg/m2 and 450 mg/m2 (165, 260, 325 mg/m2 doxorubicin equivalents, respectively) through intravenous infusion on Day 1 every 21 days for up to 6 cycles.
Interventions
DRUGINNO-206
INNO-206 at dosages of 230, 350, and 450 mg/m2 (doxorubicin equivalents of 165, 260, and 325 mg/m2) will be administered as a 30 minute IVI on Day 1 of each cycle.
Sponsors
ImmunityBio, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 70 years, male or female. * Histologically or cytologically confirmed malignant solid tumor that has relapsed or is refractory to standard therapy. * Subjects who have received prior radiation therapy with stable CNS metastasis with no progression of brain metastasis by CT/MRI scan in last 4 weeks. * Capable of providing informed consent and complying with trial procedures. * ECOG performance status 0-2. * Life expectancy \>12 weeks. * Measurable or evaluable disease according to RECIST 1.1 criteria. * Women must not be able to become pregnant (e.g. post menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study. * Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating. * Geographic accessibility to the site.
Exclusion criteria
* Palliative surgery, chemotherapy, immunotherapy and/or radiation less than 4 weeks prior to the Screening Visit. * Exposure to any investigational agent within 30 days of the Screening Visit. * Laboratory values: Screening serum creatinine greater than or equal to 1.5 mg/dL, alanine aminotransferase (ALT) greater than 3 times the upper limit of normal, total bilirubin greater than 3 times the upper limit of normal, white blood cell (WBC) count \< 3500/mm3, absolute neutrophil count \< 2000/mm3, platelet concentration \< 100,000/mm3, hematocrit level \< 33% for females or \< 35% for males, or coagulation tests (PT,PTT) \>1.5 times the upper limit or normal. * Clinically evident congestive heart failure \> class II of the New York Heart Association (NYHA) guidelines. * Serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V. * History or signs of active coronary artery disease with or without angina pectoris. * Serious myocardial dysfunction defined scintigraphically (MUGA, myocardial scintigram)or ultrasound determined absolute left ventricular ejection fraction (LVEF) \< 45% of predicted. * History of HIV infection. * Active, clinically significant serious infection requiring treatment with antibiotics, antivirals or antifungals. * Major surgery within 3 weeks prior to treatment. * Substance abuse or any condition that might interfere with the subject's participation in the study or in the evaluation of the study results. * Any condition that is unstable and could jeopardize the subject's participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | Up to 6 cycles (every 21 days) | Safety will be based on adverse events, tolerability, physical examinations, vital signs, ECG results, laboratory test results. MTD: If 2 of 5 subjects an any dose level experiences a grade 3 or 4 non-hematologic toxicity, or a platelet count \<25,000/uL or a neutrophil count \<500/uL lasting \>7 days and/or associated with fever \>38.5C, 3 more subjects will be entered at that dose level. If 2 of 3 of the additional subjects experience any of the above adverse events, the dose level immediately below will be identified as the MTD. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | Up to 6 cycles (every 21 days) | To evaluate the objective response reate (OR; RECIST 1.1 criteria). Changes in tumor measurements from baseline values that are confirmed by repeat assessments will be assigned a status of CR or PR. OR=CR+PR. |
Countries
United States
Outcome results
None listed