Malignant Solid TumourPhase 1NCT01337505
Safety and Maximum Tolerated Dose (MTD) Study of INNO-206 in Subjects With Advanced Solid Tumors
A Phase 1 study testing INNO-206 in people with Malignant Solid Tumour, run by ImmunityBio, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Malignant Solid Tumour
- What is being tested?
- INNO-206
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Dec 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sarcoma Oncology Center
Santa Monica, California, 90403
About this study
Official title: An Open-Label Phase 1 Study to Investigate the Safety and Maximum Tolerated Dose of INNO-206 (Doxorubicin-6-Maleimidocaproyl Hydrazone; DOXO-EMCH) Administered as a 30 Minute Infusion Every 3 Weeks in Subjects With Advanced Solid Tumors
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
- Being tested
- INNO-206
- Keywords
- INNO-206, Phase 1, DOXO-EMCH, Advanced solid tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INNO-206Drug
Also called DOXO-EMCH
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: INNO-206 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 cycles (every 21 days)
Secondary outcomes (1)
Objective response rate
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.
Measured: Up to 6 cycles (every 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionSep 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Solid TumourStudies of the same condition, open and under way.
- More trials run by ImmunityBio, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImmunityBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sant Chawla, M.D., Principal investigator, Sarcoma Oncology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01337505
- Sponsor's protocol ID
- INNO-206-P1-MTD-01
- Status last verified
- Feb 2013
- First submitted
- 14 Apr 2011
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Phase 1 Study to Investigate the Safety and Maximum Tolerated Dose of INNO-206 (Doxorubicin-6-Maleimidocaproyl Hydrazone; DOXO-EMCH) Administered as a 30 Minute Infusion Every 3 Weeks in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01337505
- Acronym / sponsor ID
- INNO-206-P1-MTD-01
- Conditions
- Malignant Solid Tumour
- Keywords
- INNO-206, Phase 1, DOXO-EMCH, Advanced solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- ImmunityBio, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 19 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INNO-206 | Experimental | Drug: INNO-206INNO-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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INNO-206Also: DOXO-EMCHINNO-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 |
Primary outcome
Safety
Time frame: 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.
1 secondary outcome
Objective response rate
Time frame: Up to 6 cycles (every 21 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sant Chawla, M.D. principal investigator
Sarcoma Oncology Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing INNO-206 in people with Malignant Solid Tumour, run by ImmunityBio, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: Up to 6 cycles (every 21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2022.