Relapsed Solid TumorsPhase 1/2NCT04718675
A Study of KB-0742 in Participants With Relapsed or Refractory Solid Tumors Including Platinum Resistant High Grade Serous Ovarian Cancer (HGSOC)
A Phase 1/2 study testing KB-0742 in people with Relapsed Solid Tumors and Refractory Solid Tumors, run by Kronos Bio at 24 sites in 3 countries.
Trial summary
Part 1: Dose Escalation. The primary objective of Part 1 of this study is to evaluate the safety and tolerability of KB-0742 in participants with relapsed or refractory (R/R) solid tumors or non-Hodgkin lymphoma (NHL). Part 2: Cohort Expansion. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Relapsed Solid Tumors, Refractory Solid Tumors, Non-Hodgkin Lymphoma
- What is being tested?
- KB-0742
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 24 sitesin 3 countries
- Study dates
- 8 Feb 2021to 7 Feb 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Males or females ≥ 18 years old (Parts 1 and 2A); males or females ≥ 12 years old and with a body weight ≥ 40 kg are eligible to enroll with tumor types including soft-tissue sarcomas, Ewing's sarcoma, alveolar rhabdomyosarcoma, NUT midline carcinoma (NMC), or chordoma (Part 2B)
- Willing and able to provide consent (and assent for participants between the ages of 12 to \<18)
- Part 1: Participants who meet at least 1 of the following criteria:
- Any R/R solid tumor with, in the opinion of the investigator at the time of screening has at least 1 readily accessible biopsy site(s) and who consents to 1 baseline and 1 on-treatment biopsy. If the feasibility of obtaining biopsies changes after the participant has been consented due to changes in clinical or surgical considerations and the participant otherwise meets all eligibility criteria, they may still enroll/or continue on study.
- Tumor type of interest (see list below) with measurable disease per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST) 1.1 or Positron Emission Tomography (PET) Response Criteria in Solid Tumors (PERCIST) 1.0 for solid tumors or by Lugano Classification or Modified Weighted Assessment Tool (mSWAT) for NHL AND at least 1 measurable scan per one of the above criteria prior to the most recent scan to document the rate of tumor growth before the initiation of study treatment. Tumor types of interest (R/R without other available therapeutic options) are:
- SCLC
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- Epithelial ovarian cancer, TNBC, or NSCLC
- Other epithelial solid tumor with evidence of MYC copy number gain based on local testing
- Diffuse large B-cell lymphoma with documented MYC translocation or Burkitt's lymphoma (as determined by local testing)
- Sarcoma of histologic subtypes known to be associated with transcription factor fusion, specifically: i. Myxoid/round cell sarcoma ii. Clear cell sarcoma iii. Desmoplastic small round cell tumor iv. Low grade fibromyxoid sarcoma v. Extraskeletal myxoid chondrosarcoma vi. Ewing sarcoma vii. Alveolar rhabdomyosarcoma
- Chordoma, NUT midline carcinoma, or adenoid cystic carcinoma
- Part 2, Cohort A: Participants with histologically or cytologically confirmed solid tumors who have failed, are intolerant to, or are considered ineligible for standard-of-care anti-cancer treatments. Note: Part 2, Cohort A, will include participants with relapsed or refractory solid tumors including NSCLC, TNBC and ovarian cancer.
- Part 2, Cohort B: Participants with histologically or cytologically confirmed tumor type of interest without access to or intolerant of other approved therapies, including SCLC.
- For both Parts 1 and 2:
- Access to a tumor sample for central laboratory testing
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1
- Evaluable or measurable disease, per RECIST 1.1 or PERCIST 1.0 for solid tumors or the Lugano Classification or mSWAT for NHL
- Adequate bone marrow and organ function
- Recovery from treatment-related toxicities from prior therapies to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade ≤ 1 or to baseline level
- Must agree to use highly effective birth control during the trial and for at least 3 months after the last dose of study drug; female participants cannot be pregnant or breastfeeding
Who cannot join
- Any other anti-cancer therapies including chemotherapy, immunotherapy, or hormonal therapy within 4 weeks or 5 half-lives (whichever is shorter)
- History of surgery (except for diagnostic purposes) or non-palliative radiotherapy within 4 weeks
- History of allogeneic transplantation within 6 months
- Active central nervous system (CNS) involvement by the underlying malignancy; previously treated CNS metastatic disease is permitted with magnetic resonance imaging (MRI) documentation of stable disease for at least 3 months prior to study start. Participants with SCLC with prior treatment with stereotactic radiosurgery or whole brain radiation therapy for CNS metastatic disease 2 weeks or more before study start may be considered eligible for enrollment if assessed stable and meet all other eligibility criteria.
- History of stroke or intracranial hemorrhage within ≤6 months
- History of seizure or seizure disorder, ie, recurrent seizures with an underlying etiology and requiring ongoing anti-epileptic medication
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- Current use of medications associated with seizure risk
- Active infections requiring systemic antibiotic, antiviral or antifungal therapy
- Known active coronavirus disease 2019 (COVID-19)
- Clinically significant heart disease
- Uncontrolled hypertension
- Prolongation of QT interval at baseline
- Known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection
- Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease
Trial locations and contacts
24 sites in 3 countries.
24 sites in 3 countries
United States20 sites
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
O'Neal Comprehensive Cancer Center at the University of Alabama
Birmingham, Alabama, 35233
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Cleveland Clinic - Taussig Cancer Center
Cleveland, Ohio, 44195
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
City of Hope
Duarte, California, 91010
Virginia Cancer Specialists
Fairfax, Virginia, 22031
MemorialCare - Orange Coast Medical Center
Fountain Valley, California, 92708
Pennsylvania Cancer Specialists Research Institute - Gettysburg Cancer Center
Gettysburg, Pennsylvania, 17325
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Community Health Network Community Cancer Center South
Indianapolis, Indiana, 46227
Community Health Network Community Cancer Center North
Indianapolis, Indiana, 46250
City of Hope - Orange County Lennar Foundation Cancer Center
Irvine, California, 92618
Precision NextGen Oncology
Los Angeles, California, 90025
Norris Comprehensive Cancer Center
Los Angeles, California, 90033
University of California, Los Angeles (UCLA)
Los Angeles, California, 90095
SCRI Tennessee Oncology
Nashville, Tennessee, 37203
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Washington University
St Louis, Missouri, 63110
Spain3 sites
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital Clínico San Carlos
Madrid, 28040
Hospital Universitario Quirónsalud Madrid
Madrid, 28223
United Kingdom1 site
Sarah Cannon Research Institute London
London, W1G 6AD
About this study
Official title: Phase 1, First-in-human, Open-label Dose Escalation and Cohort Expansion Study of KB-0742 in Patients With Relapsed or Refractory Solid Tumors or Non-Hodgkin Lymphoma
Part 1: Dose Escalation. The primary objective of Part 1 of this study is to evaluate the safety and tolerability of KB-0742 in participants with relapsed or refractory (R/R) solid tumors or non-Hodgkin lymphoma (NHL).
Part 2: Cohort Expansion. The primary objective of Part 2 of this study is to further evaluate the safety and tolerability of KB-0742 in defined participant cohorts including Platinum Resistant High Grade Serous Ovarian Cancer (HGSOC).
Read the detailed description
Part 2 cohort expansion is now enrolling Platinum Resistant High Grade Serous Ovarian Cancer (HGSOC) patients who may have one or more of these genetic alterations, BRCA 1 mutation, BRCA 2 mutation, MYC amplification/ overexpression, Homologous Recombination Deficient (HRD) positive.
- Conditions
- Relapsed Solid Tumors, Refractory Solid Tumors, Non-Hodgkin Lymphoma, HGSOC, Platinum Resistant High Grade Serous Ovarian Cancer
- Being tested
- KB-0742
- Keywords
- KB-0742, Relapsed Solid Tumors, Refractory Solid Tumors, Non-Hodgkin Lymphoma, CDK9 Inhibitor, Platinum Resistant High Grade Serous Ovarian Cancer, HGSOC, BRCA1 mutation, BRCA2 mutation, HRD positive, MYC amplification/overexpression
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KB-0742Drug
Oral capsules
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose Escalation | Experimental | Sequential cohorts of participants will receive escalating doses of KB-0742. Receives: Drug: KB-0742 |
| Part 2: Cohort Expansion | Experimental | Following identification of the contingent recommended Phase 2 dose (RP2D) in Part 1, the following expansion cohorts will be enrolled:
Cohort A: Participants with R/R non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), and high grade serous ovarian cancer.
Cohort B: Participants with R/R small cell lung cancer (SCLC), NUT midline carcinomas (NMC), adenoid cystic carcinoma (ACC), chordoma and soft tissue sarcomas associated with transcription factor fusion. Receives: Drug: KB-0742 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 and Part 2: Incidence of Adverse Events (AEs)
Type, incidence, severity, causality and outcome of adverse events (AEs), including serious AEs and AEs at Grade 3 or above, based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0.
Measured: Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 28 days (up to approximately 38 months)
Part 1 and Part 2: Number of Participants with Dose Limiting Toxicity (DLT) of KB-0742
Measured: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days
Part 1: Maximally Tolerated Dose (MTD) of KB-0742
Measured: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days
Part 1: Recommended Phase 2 Dose (RP2D) of KB-0742
Measured: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days
Secondary outcomes (11)
Part 1: Maximal Plasma Concentration (Cmax) of KB-0742
Measured: Cycle 1 Day 1 through Cycle 6 Day 1, where a cycle is up to 28 days
Part 1: Time to Maximal Plasma Concentration (Tmax) of KB-0742
Measured: Cycle 1 Day 1 through Cycle 6 Day 1, where a cycle is up to 28 days
Part 1: Area Under The Plasma Concentration x Time Curve From Hour 0 to The Last Measurable Time Point (AUC0-last) of KB-0742
Measured: Cycle 1 Day 1 through Cycle 6 Day 1, where a cycle is up to 28 days
Part 1 and Part 2: Progression Free Survival (PFS)
Measured: Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 28 days (up to approximately 38 months)
Part 1 and Part 2: Disease Control Rate
Measured: Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 28 days (up to approximately 38 months)
Part 1 and Part 2: Duration of Disease Control
Measured: Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 28 days (up to approximately 38 months)
Part 1 and Part 2: Overall Response Rate (ORR)
Measured: Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 28 days (up to approximately 38 months)
Part 1 and Part 2: Duration of Response (DOR)
Measured: Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 28 days (up to approximately 38 months)
Part 2: Maximal Plasma Concentration (Cmax) of KB-0742
Measured: Cycle 1 Day 1 and Cycle 1 Day 12, where a cycle is up to 28 days
Part 2: Time to Maximal Plasma Concentration (Tmax) of KB-0742
Measured: Cycle 1 Day 1 and Cycle 1 Day 12, where a cycle is up to 28 days
Part 2: Trough Concentration (Ctrough) of KB-0742
Measured: Cycle 1 Day 1 and Cycle 1 Day 12, where a cycle is up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start8 Feb 2021
- Primary completion7 Jan 2025
- Study completion7 Feb 2025
Why it stopped: Due to lack of safety and futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Solid TumorsStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kronos Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04718675
- Sponsor's protocol ID
- KB-0742-1001
- Other IDs
- 2023-503739-16-00, 2023
- Status last verified
- Nov 2024
- First submitted
- 18 Jan 2021
- Last updated
- 17 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 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, First-in-human, Open-label Dose Escalation and Cohort Expansion Study of KB-0742 in Patients With Relapsed or Refractory Solid Tumors or Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT04718675
- Acronym / sponsor ID
- KB-0742-1001
- Conditions
- Relapsed Solid Tumors, Refractory Solid Tumors, Non-Hodgkin Lymphoma, HGSOC, Platinum Resistant High Grade Serous Ovarian Cancer
- Keywords
- KB-0742, Relapsed Solid Tumors, Refractory Solid Tumors, Non-Hodgkin Lymphoma, CDK9 Inhibitor, Platinum Resistant High Grade Serous Ovarian Cancer, HGSOC, BRCA1 mutation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to lack of safety and futility
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Kronos BioIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 7 Jan 2025 (actual)
- Study completion
- 7 Feb 2025 (actual)
- First posted
- 22 Jan 2021 (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.
Part 1: Dose Escalation. The primary objective of Part 1 of this study is to evaluate the safety and tolerability of KB-0742 in participants with relapsed or refractory (R/R) solid tumors or non-Hodgkin lymphoma (NHL).
Part 2: Cohort Expansion. The primary objective of Part 2 of this study is to further evaluate the safety and tolerability of KB-0742 in defined participant cohorts including Platinum Resistant High Grade Serous Ovarian Cancer (HGSOC).
Detailed description
Part 2 cohort expansion is now enrolling Platinum Resistant High Grade Serous Ovarian Cancer (HGSOC) patients who may have one or more of these genetic alterations, BRCA 1 mutation, BRCA 2 mutation, MYC amplification/ overexpression, Homologous Recombination Deficient (HRD) positive.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose Escalation | Experimental | Drug: KB-0742Sequential cohorts of participants will receive escalating doses of KB-0742. |
| Part 2: Cohort Expansion | Experimental | Drug: KB-0742Following identification of the contingent recommended Phase 2 dose (RP2D) in Part 1, the following expansion cohorts will be enrolled: Cohort A: Participants with R/R non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), and high grade serous ovarian cancer. Cohort B: Participants with R/R small cell lung cancer (SCLC), NUT midline carcinomas (NMC), adenoid cystic carcinoma (ACC), chordoma and soft tissue sarcomas associated with transcription factor fusion. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (20 listed)
- Males or females ≥ 18 years old (Parts 1 and 2A); males or females ≥ 12 years old and with a body weight ≥ 40 kg are eligible to enroll with tumor types including soft-tissue sarcomas, Ewing's sarcoma, alveolar rhabdomyosarcoma, NUT midline carcinoma (NMC), or chordoma (Part 2B)
- Willing and able to provide consent (and assent for participants between the ages of 12 to \<18)
- Part 1: Participants who meet at least 1 of the following criteria:
- Part 2, Cohort A: Participants with histologically or cytologically confirmed solid tumors who have failed, are intolerant to, or are considered ineligible for standard-of-care anti-cancer treatments. Note: Part 2, Cohort A, will include participants with relapsed or refractory solid tumors including NSCLC, TNBC and ovarian cancer.
- Part 2, Cohort B: Participants with histologically or cytologically confirmed tumor type of interest without access to or intolerant of other approved therapies, including SCLC.
Key exclusion criteria (14 listed)
- Any other anti-cancer therapies including chemotherapy, immunotherapy, or hormonal therapy within 4 weeks or 5 half-lives (whichever is shorter)
- History of surgery (except for diagnostic purposes) or non-palliative radiotherapy within 4 weeks
- History of allogeneic transplantation within 6 months
- Active central nervous system (CNS) involvement by the underlying malignancy; previously treated CNS metastatic disease is permitted with magnetic resonance imaging (MRI) documentation of stable disease for at least 3 months prior to study start. Participants with SCLC with prior treatment with stereotactic radiosurgery or whole brain radiation therapy for CNS metastatic disease 2 weeks or more before study start may be considered eligible for enrollment if assessed stable and meet all other eligibility criteria.
- History of stroke or intracranial hemorrhage within ≤6 months
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 |
|---|---|---|
| KB-0742Oral capsules | Drug | Part 1: Dose Escalation, Part 2: Cohort Expansion |
Primary outcome
Part 1 and Part 2: Incidence of Adverse Events (AEs)
Time frame: Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 28 days (up to approximately 38 months)
Type, incidence, severity, causality and outcome of adverse events (AEs), including serious AEs and AEs at Grade 3 or above, based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0.
Part 1 and Part 2: Number of Participants with Dose Limiting Toxicity (DLT) of KB-0742
Time frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days
Part 1: Maximally Tolerated Dose (MTD) of KB-0742
Time frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days
Part 1: Recommended Phase 2 Dose (RP2D) of KB-0742
Time frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days
11 secondary outcomes
Part 1: Maximal Plasma Concentration (Cmax) of KB-0742
Time frame: Cycle 1 Day 1 through Cycle 6 Day 1, where a cycle is up to 28 days
Part 1: Time to Maximal Plasma Concentration (Tmax) of KB-0742
Time frame: Cycle 1 Day 1 through Cycle 6 Day 1, where a cycle is up to 28 days
Part 1: Area Under The Plasma Concentration x Time Curve From Hour 0 to The Last Measurable Time Point (AUC0-last) of KB-0742
Time frame: Cycle 1 Day 1 through Cycle 6 Day 1, where a cycle is up to 28 days
Part 1 and Part 2: Progression Free Survival (PFS)
Time frame: Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 28 days (up to approximately 38 months)
Part 1 and Part 2: Disease Control Rate
Time frame: Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 28 days (up to approximately 38 months)
Part 1 and Part 2: Duration of Disease Control
Time frame: Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 28 days (up to approximately 38 months)
Part 1 and Part 2: Overall Response Rate (ORR)
Time frame: Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 28 days (up to approximately 38 months)
Part 1 and Part 2: Duration of Response (DOR)
Time frame: Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 28 days (up to approximately 38 months)
Part 2: Maximal Plasma Concentration (Cmax) of KB-0742
Time frame: Cycle 1 Day 1 and Cycle 1 Day 12, where a cycle is up to 28 days
Part 2: Time to Maximal Plasma Concentration (Tmax) of KB-0742
Time frame: Cycle 1 Day 1 and Cycle 1 Day 12, where a cycle is up to 28 days
Part 2: Trough Concentration (Ctrough) of KB-0742
Time frame: Cycle 1 Day 1 and Cycle 1 Day 12, where a cycle is up to 28 days
Results and safety
The study was stopped early (reason given: Due to lack of safety and futility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 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.
24 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing KB-0742 in people with Relapsed Solid Tumors and Refractory Solid Tumors, run by Kronos Bio at 24 sites in 3 countries.
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 20 inclusion and 14 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: stopped early, as of the sponsor's last update on 17 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 24 sites in United States, Spain, United Kingdom. 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 stopped early (reason given: Due to lack of safety and futility). Results are not available in the source record.
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?
Part 1 and Part 2: Incidence of Adverse Events (AEs) (time frame: Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 28 days (up to approximately 38 months)). The study lists 4 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 17 Feb 2025.