ChordomaPhase 1/2NCT03647423
QUILT-3.091 NANT Chordoma Vaccine vs Radiation in Subjects With Unresectable Chordoma.
A Phase 1/2 study testing Aldoxorubicin Hydrochloride, ALT-803 and ETBX-051 in people with Chordoma and Unresectable Malignant Neoplasm, run by ImmunityBio, Inc. at 1 site in United States.
Trial summary
QUILT 3.091 Chordoma Vaccine: Phase 1B/2 NANT Chordoma Vaccine vs Radiation in Subjects with Unresectable Chordoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chordoma, Unresectable Malignant Neoplasm
- What is being tested?
- Aldoxorubicin Hydrochloride, ALT-803 and ETBX-051
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2018to 28 Dec 2021
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Able to understand and provide a signed informed consent that fulfills the relevant IRB or Independent Ethics Committee (IEC) guidelines.
- Histologically-confirmed recurrent or unresectable chordoma that would require radiation as a primary means for treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Have at least 1 measurable lesion of ≥ 1.0 cm.
- Must have a recent formalin-fixed, paraffin-embedded (FFPE) tumor biopsy specimen following the conclusion of the most recent anticancer treatment and be willing to release the specimen for prospective and exploratory tumor molecular profiling. If an historic specimen is not available, the subject must be willing to undergo a biopsy during the screening period, if considered safe by the Investigator. If safety concerns preclude collection of a biopsy during the screening period, a tumor biopsy specimen collected prior to the conclusion of the most recent anticancer treatment may be used.
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- Must be willing to provide blood samples prior to the start of treatment on this study for tumor molecular profiling and exploratory analyses.
- Must be willing to provide a tumor biopsy specimen 8 weeks after the start of treatment for exploratory analyses, if considered safe by the Investigator.
- Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
- Agreement to practice effective contraception for female subjects of child-bearing potential and non-sterile males. Female subjects of child-bearing potential must agree to use effective contraception for up to 1 year after completion of therapy, and non- sterile male subjects must agree to use a condom for up to 4 months after treatment. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with spermicide, intrauterine devices (IUDs), and abstinence.
- Randomized component only - 11. Must be able to be classified into at least 1 of the below 3 categories: i. Recurred within 6 months after treatment, ii. Have metastatic disease, iii. Meet ≥ 4 of the histopathologic and immunohistochemical criteria: • Poorly differentiated histopathologic sub type, • Mitotic figures ≥ 3, • Apoptosis present. • Prominent nucleoli present, • Necrosis present, • Ki67 ≥ 6%, • p53 ≥ 25%
- Single-arm component only 12. Must have progressed on or after radiation monotherapy in the randomized portion of the study OR been ineligible for the randomized portion but had progressed or experienced unacceptable toxicity on SoC prior to enrollment on the study.
Who cannot join
- Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the subject at high risk for treatment-related complications.
- Systemic autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis,Addison's disease, or autoimmune disease associated with lymphoma).
- History of organ transplant requiring immunosuppression.
- History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
- Inadequate organ function, evidenced by the following laboratory results: a. Absolute neutrophil count < 1,000 cells/mm^3, b. Uncorrectable grade 3 anemia (hemoglobin < 8 g/dL), c. Platelet count < 75,000 cells/mm^3, d. Total bilirubin greater than the upper limit of normal (ULN; unless the subject has documented Gilbert's syndrome), e. Aspartate aminotransferase (AST [SGOT]) or alanine aminotransferase (ALT [SGPT]) > 2.5 × ULN (> 5 × ULN in subjects with liver metastases), f. Alkaline phosphatase levels > 2.5 × ULN (> 5 × ULN in subjects with liver metastases, or >10 × ULN in subjects with bone metastases), g. Serum creatinine > 2.0 mg/dL or 177 μmol/L, h. Serum anion gap > 16 mEq/L or arterial blood with pH < 7.3.
- Uncontrolled hypertension (systolic > 160 mm Hg and/or diastolic > 110 mm Hg) or clinically significant (ie, active) cardiovascular disease, cerebrovascular accident/stroke, or myocardial infarction within 6 months prior to first study medication; unstable angina; congestive heart failure of New York Heart Association grade 2 or higher; or serious cardiac arrhythmia requiring medication. Subjects with uncontrolled hypertension should be medically managed on a stable regimen to control hypertension prior to study entry.
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- Serious myocardial dysfunction defined by ECHO as absolute left ventricular ejection fraction (LVEF) 10% below the institution's lower limit of predicted normal.
- Dyspnea at rest due to complications of advanced malignancy or other disease requiring continuous oxygen therapy.
- Positive results of screening test for human immunodeficiency virus (HIV).
- Current chronic daily treatment (continuous for > 3 months) with systemic corticosteroids (dose equivalent to or greater than 10 mg/day methylprednisolone), excluding inhaled steroids. Short-term steroid use to prevent IV contrast allergic reaction or anaphylaxis in subjects who have known contrast allergies is allowed.
- Known hypersensitivity to any component of the study medication(s).
- Subjects taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with any of the study medications.
- Concurrent or prior use of a strong cytochrome P450 (CYP)3A4 inhibitor (including ketoconazole, itraconazole, posaconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole, and grapefruit products) or strong CYP3A4 inducers (including phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, and St John's Wort) within 14 days before study day 1.
- Concurrent or prior use of a strong CYP2C8 inhibitor (gemfibrozil) or moderate CYP2C8 inducer (rifampin) within 14 days before study day 1.
- Participation in an investigational drug study or history of receiving any investigational treatment within 30 days prior to screening for this study, except for testosterone- lowering therapy in men with prostate cancer.
- Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
- Concurrent participation in any interventional clinical trial.
- Pregnant and nursing women.
Trial locations and contacts
1 site in 1 country.
United States1 site
Chan Soon-Shiong Institute for Medicine
El Segundo, California, 90245
About this study
Official title: QUILT-3.091 NANT Chordoma Vaccine: A Randomized Phase 1b/2 Trial of the NANT Chordoma Vaccine vs. Radiation in Subjects With Unresectable Chordoma.
QUILT 3.091 Chordoma Vaccine: Phase 1B/2 NANT Chordoma Vaccine vs Radiation in Subjects with Unresectable Chordoma.
Read the detailed description
The NANT Chordoma Vaccine regimen will be administered in 2 phases, an induction and a maintenance phase.
Subjects will continue induction treatment for up to 1 year. Those who have a confirmed complete response (CR) in the induction phase will enter the maintenance phase of the study. Subjects who experience ongoing stable disease (SD) or an ongoing partial response (PR) at 1 year may enter the maintenance phase at the Investigator's and Sponsor's discretion. Subjects may remain in the maintenance phase of the study for up to 1 year.
In the randomized component of the phase 2 portion of the study, the control arm will be treated with radiation according to established SoC protocols as determined by the Investigator.
In the phase 2 single-arm component of the study, subjects will be enrolled in the first stage of Simon's two-stage optimal design. If the study proceeds to the second stage of Simon's two-stage optimal design, additional subjects will be enrolled in the second stage.
- Conditions
- Chordoma, Unresectable Malignant Neoplasm
- Being tested
- Aldoxorubicin Hydrochloride, ALT-803, ETBX-051, ETBX-061, GI-6301
- Medical subject headings
- Chordoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aldoxorubicin HydrochlorideBiological
Aldoxorubicin Hydrochloride HCI
ALT-803Biological
Recombinant human super agonist interleukin-15 (IL-15) complex
ETBX-051Biological
Ad5 [E1-, E2b-]-Brachyury
ETBX-061Biological
Ad5 [E1-, E2b-]-mucin 1 [MUC1]
GI-6301Biological
Brachyury yeast
haNKBiological
haNK™, NK-92 [CD16.158V, ER IL-2]
AvelumabDrug
Also called BAVENCIO®
injection
CetuximabDrug
Also called ERBITUX®
Injection
CyclophosphamideDrug
Also called Cytoxan
Capsules
SBRTRadiation
Stereotactic body radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| NANT Chordoma Vaccine | Experimental | A combination of agents will be administered to subjects in this study: Aldoxorubicin Hydrochloride HCI, ALT-803, ETBX-051, ETBX-061, GI-6301, haNK, avelumab, cetuximab, cyclophosphamide, SBRT. Receives: Biological: Aldoxorubicin Hydrochloride; Biological: ALT-803; Biological: ETBX-051; Biological: ETBX-061; Biological: GI-6301; Biological: haNK; Drug: Avelumab; Drug: Cetuximab; Drug: Cyclophosphamide |
| Controlled Arm - Radiation | Active comparator | SBRT Receives: Radiation: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs), graded using the NCI CTCAE Version 4.03.
Phase 1b primary endpoint
Measured: 9 weeks
Progression-free survival (PFS) by RECIST v1.1
Phase 2 primary endpoint
Measured: 1 years
Secondary outcomes (16)
Objective response rate by RECIST v1.1
Phase 1b secondary endpoint
Measured: 9 weeks
Objective response rate by irRC
Phase 1b secondary endpoint
Measured: 9 weeks
Progression-free survival (PFS) by RECIST v1.1
Phase 1b secondary endpoint
Measured: 9 weeks
Progression-free survival (PFS) by irRC
Phase 1b secondary endpoint
Measured: 9 weeks
Overall survival
Phase 1b secondary endpoint
Measured: 9 weeks
Disease control rate by RECIST v1.1 and irRC.
Phase 1b secondary endpoint
Measured: 1 year
Disease control rate (confirmed complete response, partial response, or stable disease lasting for at least 2 months) by RECIST v1.1 and irRC.
Phase 1b secondary endpoint
Measured: 1 year
Patient-reported outcomes of Chordoma cancer symptoms
Phase 1b secondary endpoint (by RECIST v1.1 and irRC and FACT-Hep questionnaire)
Measured: 1 year
Progression-free survival (PFS) by irRC
Phase 2 secondary endpoint
Measured: 1 year
Objective response rate by RECIST 1.1
Phase 2 secondary endpoint
Measured: 1 year
Objective response rate by irRC
Phase 2 secondary endpoint
Measured: 1 year
Overall survival
Phase 2 secondary endpoint
Measured: 1 year
Duration of response by RECIST and irRC
Phase 2 secondary endpoint
Measured: 1 year
Disease control rate (confirmed complete response, partial response, or stable disease lasting for at least 2 months) by RECIST and irRC.
Phase 2 secondary endpoint
Measured: 1 year
Patient-reported outcomes of Chordoma cancer
Phase 2 secondary endpoint
Measured: 1 year
Incidence of treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs), graded using the NCI CTCAE Version 4.03.
Phase 2 secondary endpoint by (RECIST v1.1 and irRC and FACT-Hep questionnaire)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start31 Aug 2018 (estimated)
- Primary completion31 Aug 2020 (estimated)
- Study completion28 Dec 2021
Why it stopped: Trial not initiated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChordomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Chordoma Vaccine: A randomized phase 1b/2 trial of the NANT chordoma vaccine vs. radiation in subjects with unresectable chordoma.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImmunityBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03647423
- Sponsor's protocol ID
- QUILT-3.091
- Status last verified
- Aug 2018
- First submitted
- 9 Aug 2018
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QUILT-3.091 NANT Chordoma Vaccine: A Randomized Phase 1b/2 Trial of the NANT Chordoma Vaccine vs. Radiation in Subjects With Unresectable Chordoma.
- ClinicalTrials.gov ID
- NCT03647423
- Acronym / sponsor ID
- QUILT-3.091
- Conditions
- Chordoma, Unresectable Malignant Neoplasm
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Trial not initiated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ImmunityBio, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2018 (estimated)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 28 Dec 2021 (actual)
- First posted
- 27 Aug 2018 (actual)
- 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.
QUILT 3.091 Chordoma Vaccine: Phase 1B/2 NANT Chordoma Vaccine vs Radiation in Subjects with Unresectable Chordoma.
Detailed description
The NANT Chordoma Vaccine regimen will be administered in 2 phases, an induction and a maintenance phase.
Subjects will continue induction treatment for up to 1 year. Those who have a confirmed complete response (CR) in the induction phase will enter the maintenance phase of the study. Subjects who experience ongoing stable disease (SD) or an ongoing partial response (PR) at 1 year may enter the maintenance phase at the Investigator's and Sponsor's discretion. Subjects may remain in the maintenance phase of the study for up to 1 year.
In the randomized component of the phase 2 portion of the study, the control arm will be treated with radiation according to established SoC protocols as determined by the Investigator.
In the phase 2 single-arm component of the study, subjects will be enrolled in the first stage of Simon's two-stage optimal design. If the study proceeds to the second stage of Simon's two-stage optimal design, additional subjects will be enrolled in the second stage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Chordoma Vaccine: A randomized phase 1b/2 trial of the NANT chordoma vaccine vs. radiation in subjects with unresectable chordoma.
| Arm | Type | Receives |
|---|---|---|
| NANT Chordoma Vaccine | Experimental | Biological: Aldoxorubicin Hydrochloride, Biological: ALT-803, Biological: ETBX-051, Biological: ETBX-061, Biological: GI-6301, Biological: haNK, Drug: Avelumab, Drug: Cetuximab, Drug: CyclophosphamideA combination of agents will be administered to subjects in this study: Aldoxorubicin Hydrochloride HCI, ALT-803, ETBX-051, ETBX-061, GI-6301, haNK, avelumab, cetuximab, cyclophosphamide, SBRT. |
| Controlled Arm - Radiation | Active comparator | Radiation: SBRTSBRT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 18 years.
- Able to understand and provide a signed informed consent that fulfills the relevant IRB or Independent Ethics Committee (IEC) guidelines.
- Histologically-confirmed recurrent or unresectable chordoma that would require radiation as a primary means for treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Have at least 1 measurable lesion of ≥ 1.0 cm.
Key exclusion criteria (18 listed)
- Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the subject at high risk for treatment-related complications.
- Systemic autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis,Addison's disease, or autoimmune disease associated with lymphoma).
- History of organ transplant requiring immunosuppression.
- History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
- Inadequate organ function, evidenced by the following laboratory results: a. Absolute neutrophil count < 1,000 cells/mm^3, b. Uncorrectable grade 3 anemia (hemoglobin < 8 g/dL), c. Platelet count < 75,000 cells/mm^3, d. Total bilirubin greater than the upper limit of normal (ULN; unless the subject has documented Gilbert's syndrome), e. Aspartate aminotransferase (AST [SGOT]) or alanine aminotransferase (ALT [SGPT]) > 2.5 × ULN (> 5 × ULN in subjects with liver metastases), f. Alkaline phosphatase levels > 2.5 × ULN (> 5 × ULN in subjects with liver metastases, or >10 × ULN in subjects with bone metastases), g. Serum creatinine > 2.0 mg/dL or 177 μmol/L, h. Serum anion gap > 16 mEq/L or arterial blood with pH < 7.3.
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 |
|---|---|---|
| Aldoxorubicin HydrochlorideAldoxorubicin Hydrochloride HCI | Biological | NANT Chordoma Vaccine |
| ALT-803Recombinant human super agonist interleukin-15 (IL-15) complex | Biological | NANT Chordoma Vaccine |
| ETBX-051Ad5 [E1-, E2b-]-Brachyury | Biological | NANT Chordoma Vaccine |
| ETBX-061Ad5 [E1-, E2b-]-mucin 1 [MUC1] | Biological | NANT Chordoma Vaccine |
| GI-6301Brachyury yeast | Biological | NANT Chordoma Vaccine |
| haNKhaNK™, NK-92 [CD16.158V, ER IL-2] | Biological | NANT Chordoma Vaccine |
| AvelumabAlso: BAVENCIO®injection | Drug | NANT Chordoma Vaccine |
| CetuximabAlso: ERBITUX®Injection | Drug | NANT Chordoma Vaccine |
| CyclophosphamideAlso: CytoxanCapsules | Drug | NANT Chordoma Vaccine |
| SBRTStereotactic body radiation therapy | Radiation | Controlled Arm - Radiation |
Primary outcome
Incidence of treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs), graded using the NCI CTCAE Version 4.03.
Time frame: 9 weeks
Phase 1b primary endpoint
Progression-free survival (PFS) by RECIST v1.1
Time frame: 1 years
Phase 2 primary endpoint
16 secondary outcomes
Objective response rate by RECIST v1.1
Time frame: 9 weeks
Objective response rate by irRC
Time frame: 9 weeks
Progression-free survival (PFS) by RECIST v1.1
Time frame: 9 weeks
Progression-free survival (PFS) by irRC
Time frame: 9 weeks
Overall survival
Time frame: 9 weeks
Disease control rate by RECIST v1.1 and irRC.
Time frame: 1 year
Disease control rate (confirmed complete response, partial response, or stable disease lasting for at least 2 months) by RECIST v1.1 and irRC.
Time frame: 1 year
Patient-reported outcomes of Chordoma cancer symptoms
Time frame: 1 year
Progression-free survival (PFS) by irRC
Time frame: 1 year
Objective response rate by RECIST 1.1
Time frame: 1 year
Objective response rate by irRC
Time frame: 1 year
Overall survival
Time frame: 1 year
Duration of response by RECIST and irRC
Time frame: 1 year
Disease control rate (confirmed complete response, partial response, or stable disease lasting for at least 2 months) by RECIST and irRC.
Time frame: 1 year
Patient-reported outcomes of Chordoma cancer
Time frame: 1 year
Incidence of treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs), graded using the NCI CTCAE Version 4.03.
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Aldoxorubicin Hydrochloride, ALT-803 and ETBX-051 in people with Chordoma and Unresectable Malignant Neoplasm, 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 12 inclusion and 18 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: withdrawn, as of the sponsor's last update on 21 Feb 2025. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Incidence of treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs), graded using the NCI CTCAE Version 4.03. (time frame: 9 weeks). The study lists 2 primary outcomes in all. 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 21 Feb 2025.