Safety and Maximum Tolerated Dose (MTD) Study of INNO-206 in Subjects With Advanced Solid Tumors

NCT01337505 | Completed Phase 1

• 1 other identifier: INNO-206-P1-MTD-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Solid Tumour

Keywords

INNO-206; Phase 1; DOXO-EMCH; Advanced solid tumors

Outcome Measures

Primary Outcomes (1)

• Safety

  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.

  Up to 6 cycles (every 21 days)

Secondary Outcomes (1)

• Objective response rate

  Up to 6 cycles (every 21 days)

Study Arms (1)

INNO-206

EXPERIMENTAL

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

Interventions

INNO-206 DRUG

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.

Also known as: DOXO-EMCH

INNO-206

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ImmunityBio, Inc.: lead

Study Sites (1)

Sarcoma Oncology Center

Santa Monica, California, 90403, United States

Location

MeSH Terms

Interventions

DOXO-EMCH

Study Officials

• Sant Chawla, M.D.

  Sarcoma Oncology Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2011
• First Posted: April 19, 2011
• Study Start: April 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 10, 2022

Record last verified: 2013-02

Locations

US (1)