Locally Advanced Solid TumorPhase 1/2NCT05268666
A Study of Orally Administered JBI-802, an LSD1/HDAC6 Inhibitor, in Patients With Advanced Solid Tumors
A Phase 1/2 study testing JBI-802 in people with Locally Advanced Solid Tumor and Metastatic Solid Tumor, run by Jubilant Therapeutics Inc. at 4 sites in United States.
Trial summary
The purpose of this study is to determine the maximum-tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of JBI-802 in patients with Advanced Solid Tumors.The efficacy of the RP2D will be evaluated in phase 2 in patients with solid tumors of neuroendocrine differentiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Solid Tumor, Metastatic Solid Tumor
- What is being tested?
- JBI-802
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 4 sitesUnited States
- Study dates
- 8 Apr 2022to Aug 2025
- 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
- Males or females aged ≥18 years at Screening
- Absolute neutrophil count (ANC) ≥1500 cells/mm3.
- Platelet count ≥100,000 cells/mm3.
- Total bilirubin ≤1.5×ULN. Patients with Gilbert's syndrome may be enrolled with up to 3.0xULN.
- AST and ALT ≤2.5×ULN (unless liver metastases are present then up to 5×ULN is allowed).
- Calculated creatinine clearance (CrCL) ≥60 mL/min (Cockcroft-Gault formula).
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- Prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤1.5×ULN if participant is not anticoagulated (Note: If participant is on anticoagulants, the participant must be on a stable dose for at least 2 weeks prior to study entry.
- Must have at least one measurable lesion on CT scan or MRI per RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
- Other criteria may apply
- Part 1:
- Participants with a histologically confirmed diagnosis of locally advanced or metastatic solid tumors (except microsatellite stable colorectal cancer and hepatocellular carcinoma) who have no available effective therapeutic options.
- Part 2:
- Small cell lung cancer: Participants must have a histologic diagnosis of advanced SCLC not amenable to curative therapy and have received ≤2 prior regimens, which must have included a checkpoint inhibitor and a platinum-based chemotherapy.
- De novo or treatment-emergent NEPC
- Basket of neuroendocrine-derived tumors, excluding SCLC and treatment-induced NEPC. Participants must have unresectable locally advanced or metastatic disease and have no available effective therapeutic options.
Who cannot join
- Known malignant central nervous system (CNS) disease other than neurologically stable, treated brain metastases - defined as metastasis having no evidence of progression or hemorrhage for at least 4 weeks after treatment (including brain radiotherapy). Must be off any systemic corticosteroids for the treatment of symptomatic brain metastases for at least 14 days prior to enrollment.
- Severe or unstable medical condition, such as congestive heart failure (New York Heart Association [NYHA] Class III or Class IV), ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus, psychiatric condition, as well as an uncontrolled cardiac arrhythmia requiring medication (≥Grade 2, according to NCI CTCAE Version 5), myocardial infarction within 6 months prior to starting study treatment, or any other significant or unstable concurrent cardiac illness. Note: Stable chronic atrial fibrillation is allowed.
- Use of strong inhibitors of CYP3A within 14 days or 5 half-lives (whichever is longer) or grapefruit juice or grapefruit containing products within 7 days prior to Cycle 1 Day 1.
- Use of strong inducers of CYP3A within 14 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.
- Use of strong inhibitors of cytochrome CYP2D6 within 14 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.
- Use of strong inducers of CYP2D6 within 14 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.
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- History of other previous or concurrent cancer that would interfere with the determination of safety or efficacy assessment
- Surgery (eg, stomach bypass) or medical condition that might significantly affect absorption of medicines
- Other criteria may apply
Trial locations and contacts
4 sites in 1 country.
Director, Program Management contact
United States4 sites, 1 recruiting
- Recruiting
The Christ Hospital
Cincinnati, Ohio, 45219
- Completed
Sarah Cannon Research Institute at HealthOne
Denver, Colorado, 82018
- Completed
NEXT Virginia, LLC
Fairfax, Virginia, 22031
- Completed
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203
About this study
Official title: A First-in-Human, Open-label, Dose Escalation and Expansion Study of Orally Administered JBI-802 in Patients With Advanced Solid Tumors
The purpose of this study is to determine the maximum-tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of JBI-802 in patients with Advanced Solid Tumors.The efficacy of the RP2D will be evaluated in phase 2 in patients with solid tumors of neuroendocrine differentiation.
Read the detailed description
This is a multi-center, first in human, open-label, 2-part, dose escalation and expansion study to define safety, tolerability, maximum tolerated dose, pharmacologically active dose, assess preliminary efficacy, and explore predictive and pharmacodynamic biomarkers in up to 126 participants with advanced solid tumors. Expansion cohorts of participants, treated at the RP2D, with small cell lung cancer (SCLC), neuroendocrine prostate cancer (NEPC), and other neuroendocrine-derived cancers will be enrolled to obtain additional safety and efficacy data. Starting dose will be 10 mg orally once daily, 4 days on and 3 days off cycle.
- Being tested
- JBI-802
- Keywords
- SCLC, neuroendocrine prostate cancer, neuroendocrine, JBI-802
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JBI-802Drug
LSD1/HDAC6 inhibitor
| Study group | Role | What they receive |
|---|---|---|
| JBI-802 | Experimental | 10 mg JBI-802 once daily as the starting dose with 4 days on/3 days off cycle Receives: Drug: JBI-802 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum-Tolerated Dose (MTD)
Measured: 28-day cycle
Investigator-Assessed ORR (Part 2)
Defined as either complete response (CR) or partial response (PR) as defined by RECIST version 1.1
Measured: Up to 30 days from the last dose of study drug
Secondary outcomes (14)
Incidence of AEs
Characterized overall and by type, seriousness, relationship to study treatment, timing, and severity graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Measured: Up to 30 days from the last dose of study drug
Cmax: Maximum Plasma Concentration JBI-802
Defined as the maximum observed drug concentration observed in plasma over all PK sample concentrations.
Measured: Baseline up to 28 days from the last dose of study drug
Tmax: Time of Maximum Plasma Concentration JBI-802
Defined as the time at which the Cmax occurs.
Measured: Baseline up to 28 days from the last dose of study drug
Clast: Last Observed (quantifiable) Plasma Concentration in units of ng/mL JBI-802
Last Observed (quantifiable) Plasma Concentration in units of ng/mL JBI-802
Measured: Baseline up to 28 days from the last dose of study drug
AUC(0-last): Area Under the Concentration-time Curve from Dosing (time 0) to Time of Last Measured Concentration JBI-802
AUCs will be reported in units of h×ng/mL
Measured: Baseline up to 28 days from the last dose of study drug
AUC(0-t) (partial AUC): Area Under the Concentration-time Curve from Dosing (time 0) to Time t JBI-802
May be computed for one or more values of t, with specific values of t determined after observing the data; AUCs will be reported in units of h×ng/mL
Measured: Baseline up to 28 days from the last dose of study drug
Vd/F: Apparent Volume of Distribution During Terminal Phase (Vz/F) After Oral Administration calculated as (CL/F)/ Ke
Volume will be reported in units of L.
Measured: Baseline up to 28 days from the last dose of study drug
CL/F: Apparent Oral Clearance (CL/F) computed as Dose/AUC
Clearance will be reported in units of L/h.
Measured: Baseline up to 28 days from the last dose of study drug
t½: The Apparent Terminal Elimination Half-life JBI-802
The time required for the drug concentration to decrease by a factor of one-half in the terminal phase. t½ can be estimated as ln(2) / Ke. t1/2 will be reported in units of h.
Measured: Baseline up to 28 days from the last dose of study drug
Investigator-Assessed Overall Response Rate (ORR) (Part 1)
ORR is defined as the percentage of patients with a confirmed complete response (CR) or a partial response based on RECIST 1.1
Measured: Up to 30 days from the last dose of study drug
Duration of Response (DOR)
Time from the date of first documented CR or PR, assessed by the investigator and based on RECIST 1.1 to the documented date of progressive disease (PD) or death, whichever occurred first
Measured: Up to 30 days from the last dose of study drug
PFS: Progression Free Survival
The time from the date the patient started study drug to the date the patient experiences an event of disease progression
Measured: Date patient started study drug to date of progression, assessed up to 30 months
OS: Overall Survival
The time from the date patient started study drug to death for any reason
Measured: Date patient started study drug to date of death for any cause, assessed up to 30 months
PSA 50 Response Rate in Patients with Prostate Cancer
The percentage of patients who experience a ≥50% decline in PSA from baseline.
Measured: Baseline up to 30 days from the last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start8 Apr 2022
- Primary completionDec 2024 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Solid TumorStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jubilant Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Program Manager, Study director, Jubilant Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268666
- Sponsor's protocol ID
- JBI-802-101
- Status last verified
- Aug 2022
- First submitted
- 11 Feb 2022
- Last updated
- 15 Jun 2023
- Results posted
- No
- 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 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human, Open-label, Dose Escalation and Expansion Study of Orally Administered JBI-802 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05268666
- Acronym / sponsor ID
- JBI-802-101
- Keywords
- SCLC, neuroendocrine prostate cancer, neuroendocrine, JBI-802
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Jubilant Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Apr 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 7 Mar 2022 (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.
The purpose of this study is to determine the maximum-tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of JBI-802 in patients with Advanced Solid Tumors.The efficacy of the RP2D will be evaluated in phase 2 in patients with solid tumors of neuroendocrine differentiation.
Detailed description
This is a multi-center, first in human, open-label, 2-part, dose escalation and expansion study to define safety, tolerability, maximum tolerated dose, pharmacologically active dose, assess preliminary efficacy, and explore predictive and pharmacodynamic biomarkers in up to 126 participants with advanced solid tumors. Expansion cohorts of participants, treated at the RP2D, with small cell lung cancer (SCLC), neuroendocrine prostate cancer (NEPC), and other neuroendocrine-derived cancers will be enrolled to obtain additional safety and efficacy data. Starting dose will be 10 mg orally once daily, 4 days on and 3 days off cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JBI-802 | Experimental | Drug: JBI-80210 mg JBI-802 once daily as the starting dose with 4 days on/3 days off cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Males or females aged ≥18 years at Screening
- Absolute neutrophil count (ANC) ≥1500 cells/mm3.
- Platelet count ≥100,000 cells/mm3.
- Total bilirubin ≤1.5×ULN. Patients with Gilbert's syndrome may be enrolled with up to 3.0xULN.
- AST and ALT ≤2.5×ULN (unless liver metastases are present then up to 5×ULN is allowed).
Key exclusion criteria (9 listed)
- Known malignant central nervous system (CNS) disease other than neurologically stable, treated brain metastases - defined as metastasis having no evidence of progression or hemorrhage for at least 4 weeks after treatment (including brain radiotherapy). Must be off any systemic corticosteroids for the treatment of symptomatic brain metastases for at least 14 days prior to enrollment.
- Severe or unstable medical condition, such as congestive heart failure (New York Heart Association [NYHA] Class III or Class IV), ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus, psychiatric condition, as well as an uncontrolled cardiac arrhythmia requiring medication (≥Grade 2, according to NCI CTCAE Version 5), myocardial infarction within 6 months prior to starting study treatment, or any other significant or unstable concurrent cardiac illness. Note: Stable chronic atrial fibrillation is allowed.
- Use of strong inhibitors of CYP3A within 14 days or 5 half-lives (whichever is longer) or grapefruit juice or grapefruit containing products within 7 days prior to Cycle 1 Day 1.
- Use of strong inducers of CYP3A within 14 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.
- Use of strong inhibitors of cytochrome CYP2D6 within 14 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.
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 |
|---|---|---|
| JBI-802LSD1/HDAC6 inhibitor | Drug | JBI-802 |
Primary outcome
Maximum-Tolerated Dose (MTD)
Time frame: 28-day cycle
Investigator-Assessed ORR (Part 2)
Time frame: Up to 30 days from the last dose of study drug
Defined as either complete response (CR) or partial response (PR) as defined by RECIST version 1.1
14 secondary outcomes
Incidence of AEs
Time frame: Up to 30 days from the last dose of study drug
Cmax: Maximum Plasma Concentration JBI-802
Time frame: Baseline up to 28 days from the last dose of study drug
Tmax: Time of Maximum Plasma Concentration JBI-802
Time frame: Baseline up to 28 days from the last dose of study drug
Clast: Last Observed (quantifiable) Plasma Concentration in units of ng/mL JBI-802
Time frame: Baseline up to 28 days from the last dose of study drug
AUC(0-last): Area Under the Concentration-time Curve from Dosing (time 0) to Time of Last Measured Concentration JBI-802
Time frame: Baseline up to 28 days from the last dose of study drug
AUC(0-t) (partial AUC): Area Under the Concentration-time Curve from Dosing (time 0) to Time t JBI-802
Time frame: Baseline up to 28 days from the last dose of study drug
Vd/F: Apparent Volume of Distribution During Terminal Phase (Vz/F) After Oral Administration calculated as (CL/F)/ Ke
Time frame: Baseline up to 28 days from the last dose of study drug
CL/F: Apparent Oral Clearance (CL/F) computed as Dose/AUC
Time frame: Baseline up to 28 days from the last dose of study drug
t½: The Apparent Terminal Elimination Half-life JBI-802
Time frame: Baseline up to 28 days from the last dose of study drug
Investigator-Assessed Overall Response Rate (ORR) (Part 1)
Time frame: Up to 30 days from the last dose of study drug
Duration of Response (DOR)
Time frame: Up to 30 days from the last dose of study drug
PFS: Progression Free Survival
Time frame: Date patient started study drug to date of progression, assessed up to 30 months
OS: Overall Survival
Time frame: Date patient started study drug to date of death for any cause, assessed up to 30 months
PSA 50 Response Rate in Patients with Prostate Cancer
Time frame: Baseline up to 30 days from the last dose of study drug
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- 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.
Director, Program Management contact
Program Manager study director
Jubilant Therapeutics Inc.
4 sites 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 JBI-802 in people with Locally Advanced Solid Tumor and Metastatic Solid Tumor, run by Jubilant Therapeutics Inc. at 4 sites 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 16 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chief Scientific Officer ((443) 515-9637, luca.rastelli@jubilanttx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum-Tolerated Dose (MTD) (time frame: 28-day cycle). 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 15 Jun 2023.