Safety and Maximum Tolerated Dose (MTD) Study of INNO-206 in Subjects With Advanced Solid Tumors
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: INNO-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. |
Drug: INNO-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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age between 18 and 70 years, male or female.
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Histologically or cytologically confirmed malignant solid tumor that has relapsed or is refractory to standard therapy.
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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.
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Capable of providing informed consent and complying with trial procedures.
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ECOG performance status 0-2.
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Life expectancy >12 weeks.
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Measurable or evaluable disease according to RECIST 1.1 criteria.
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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.
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Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating.
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Geographic accessibility to the site.
Exclusion Criteria:
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Palliative surgery, chemotherapy, immunotherapy and/or radiation less than 4 weeks prior to the Screening Visit.
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Exposure to any investigational agent within 30 days of the Screening Visit.
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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.
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Clinically evident congestive heart failure > class II of the New York Heart Association (NYHA) guidelines.
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Serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V.
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History or signs of active coronary artery disease with or without angina pectoris.
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Serious myocardial dysfunction defined scintigraphically (MUGA, myocardial scintigram)or ultrasound determined absolute left ventricular ejection fraction (LVEF) < 45% of predicted.
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History of HIV infection.
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Active, clinically significant serious infection requiring treatment with antibiotics, antivirals or antifungals.
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Major surgery within 3 weeks prior to treatment.
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Substance abuse or any condition that might interfere with the subject's participation in the study or in the evaluation of the study results.
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Any condition that is unstable and could jeopardize the subject's participation in the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sarcoma Oncology Center | Santa Monica | California | United States | 90403 |
Sponsors and Collaborators
- ImmunityBio, Inc.
Investigators
- Principal Investigator: Sant Chawla, M.D., Sarcoma Oncology Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- INNO-206-P1-MTD-01