Advanced Solid TumorsPhase 1NCT06096974
Pan-RAS Inhibitor YL-17231 in Patients With Advanced Solid Tumors Harboring Mutations in KRAS, HRAS, or NRAS
A Phase 1 study testing YL-17231 in people with Advanced Solid Tumors, run by Shanghai YingLi Pharmaceutical Co. Ltd. at 3 sites in United States.
Trial summary
This study will evaluate the safety, tolerability, drug levels, pharmacodynamic effects, and clinical activity of YL 17231 in patients with advanced solid tumors harboring mutations in KRAS, HRAS, or NRAS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- YL-17231
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- 24 Oct 2023to Apr 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Unresectable or metastatic advanced solid tumors with no standard therapies, or having progressed on or intolerable to standard therapies.
- Advanced solid tumors harboring mutations in KRAS, HRAS or NRAS as determined by laboratory testing, including local laboratory testing.
- Measurable disease with at least one lesion amenable to response assessment per RECIST 1.1.
- Demonstrate adequate organ function as defined below. All screening laboratories should be performed within 7 days of study treatment initiation.
- 1）Absolute neutrophil count (ANC) ≥1.2 × 10^9/L；2）Platelets ≥100 × 10^9/L Hemoglobin ≥9 g/dL or ≥5.6 mmol/L；3）Measured or calculated creatinine clearance (CrCl)(Cockcroft-Gault) ≥60 mL/min；4）Total bilirubin ≤1.5 × ULN (patients with Gilbert's syndrome, total bilirubin ≤3.0 × ULN) ；5）Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN or ≤5 × ULN for patients with liver metastases
- Has an ECOG performance status of 0-1.
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- Life expectancy ≥12 weeks at baseline.
- Women of childbearing potential must have negative serum or urine pregnancy test within 72 hours prior to receiving the first study drug administration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- For women of childbearing potential, must be willing to use an adequate method of contraception from 30 days prior to the first study drug administration and at least 3 months following last day study drug administration.
- Male patients of childbearing potential must be surgically sterile, or must agree to use adequate method of contraception during the study and at least 3 months following the last day of study drug administration.
- Age ≥18 years at screening.
- Able and willing to provide written informed consent and to follow study instructions.
- Washout from prior anti-tumor therapy:1）Cytotoxic therapies ≥ 3 weeks Mitomycin C or nitrosoureas ≥ 6 weeks；2）Small molecule agents ≥2 weeks or 5x T1/2, whichever is longer；3）Biologic agents (e.g., antibodies) ≥ 4weeks Immunotherapy (e.g., CTLA4, PD-1, PD-L1 inhibitors) ≥ 4 weeks；4）Radiotherapy ≥ 4 weeks；5）Limited field radiotherapy or palliative radiotherapy ≥ 2 weeks ；6）Major surgery, excluding biopsy ≥ 4 weeks (exception: patients may enroll if fully recovered or without intolerable or clinically significant adverse effects, but at least 14 days must have elapsed between major surgery and first study drug administration)；7）Study drug with an investigational product, or non-approved use of a drug or device ≥ 4 weeks (≥2 weeks or 5x T1/2, whichever is longer for small molecule agents
Who cannot join
- Known symptomatic brain metastases requiring dexamethasone ≥4mg (or equivalent) or requiring steroid dose increase within 14 days prior to the first dose of YL-17231.
- Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment.
- Unresolved toxicities from prior therapy, defined as having not resolved to NCI CTCAE v.5.0 Grade ≤1 1 or baseline, with exception of endocrinopathies from prior therapy and successfully treated (such as hypothyroidism), alopecia, vitiligo, and ≤ grade 2 peripheral neuropathy.
- Human immunodeficiency virus (HIV) infection with a current or a known history of AIDS-defining illness or HIV infection with a CD4+ T cell count <350 cells/µL and an HIV viral load more than 400 copies/µL.
- Patients with active viral (any etiology) hepatitis are excluded. However, patients with serologic evidence of chronic hepatitis B virus (HBV) infection (defined by a positive hepatitis B surface antigen test and a positive anti-hepatitis core antigen antibody test) who have a viral load below the limit quantification (HBV DNA titer <1000 cps/mL or 200 IU/mL), and are not currently on viral suppressive therapy may be eligible and should be discussed with the Medical Monitor. Patients with a history of hepatitis C virus (HCV) infection who have completed curative antiviral treatment and have a viral load below the limit of quantitation may be eligible and should be discussed with the Medical Monitor.
- Any of the following cardiac criteria experienced currently or within the last 6 months:
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- Congestive heart failure (New York Heart Association ≥ Class 2).
- Any clinically significant abnormalities (as assessed by the Investigator) in rhythm, conduction, or morphology of resting electrocardiograms (ECGs), e.g., complete left bundle branch block or third-degree heart block.
- Acute coronary syndrome within 6 months.
- Clinically significant cardiac arrhythmia.
- Mean QTC interval corrected (Frederica) for heart rate >450 ms.
- Left ventricular ejection fraction (LVEF) <50% or the lower limit of normal (per institutional standard).
- Evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, uncontrolled diabetes mellitus, active bleeding diatheses, or active infection, as determined by the investigator.
- Any condition that impairs a patient's ability to swallow whole pills. Presence of an active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of YL-17231, as determined by the investigator.
- History noninfectious pneumonitis required steroids treatment or concurrent pneumonitis or interstitial lung diseases.
- An active additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
- Known allergy to any component of YL-17231.
- Patient has known psychiatric, substance abuse or other disorders that would interfere with cooperation with the requirements of the trial, in the opinion of the investigator.
- Patients who are pregnant or breastfeeding or expecting to conceive within the projected duration of the trial, starting with the screening visit through 3 months after the last dose of trial treatment.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
The Lindner Center for Research & Education at The Christ Hospital
Cincinnati, Ohio, 45219
Alexander Starodub, (513) 321-4333
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
David Hong, PhD, (713) 563-1930
- Recruiting
Huntsman Cancer Institute and Hospital, University of Utah
Salt Lake City, Utah, 84112
Ignacio Garrido-Laguna, (801) 585-0255
About this study
Official title: A Multi-Center, Open-Label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of Pan-RAS Inhibitor YL-17231 in Patients With Advanced Solid Tumors Harboring Mutations in KRAS, HRAS, or NRAS
This study will evaluate the safety, tolerability, drug levels, pharmacodynamic effects, and clinical activity of YL 17231 in patients with advanced solid tumors harboring mutations in KRAS, HRAS, or NRAS.
Read the detailed description
The study is a Phase 1, multi-center, open label study in 2 parts.
Part 1 (Phase Ia):
This is a 3 + 3 design dose escalation study, to evaluate the safety and tolerability, and to determine the MTD and/or RP2D of YL-17231 treatment when administered orally QD in patients with advanced solid tumors harboring mutations in KRAS, HRAS or NRAS. Up to 9 doses cohorts are planned for the dose escalation part of the study, with the starting dose of 0.25mg QD. The actual number of dose cohorts to be explored in this study will be determined by the non-tolerable dose based on dose limiting toxicities (DLTs) in conjunction with the PK and preliminary efficacy signal data. If suggested by safety and PK findings from planned dose treatment cohorts, additional dose levels may be evaluated and dosing interval may be modified under the Safety Monitoring Committee (SMC) guidance.
In Part 1, the 3+3 trial design for the dose escalation will be used and a total of 9 dose levels starting dose of 0.25 mg OD is planned.
One cycle is 21 days. DLT observation period is one cycle. The maximum tolerated dose (MTD) is the highest dose at which ≤1 of 6 patients experiences a DLT during the DLT observation period. The study will identify a maximum tolerated dose (MTD) if possible, with safety and tolerability data. All available data, including safety, tolerability, PK, PD and preliminary anti-tumor activity from each cohort will be reviewed by the SMC to determine the RP2D.
Patients may be permitted an intra-patient dose-escalation of YL-17231 to a higher dose level that has been cleared and deemed safe by the SMC if they have completed Cycle 2 at their initial enrolled dose level and continued on-study with no treatment related ≥ Grade 2 AEs. The Investigator must consult with the Medical Monitor to confirm if the patient is permitted be dose-escalated to a dose-level already cleared by the SMC.
Backfilling Additional patients (up to total of 12) may be enrolled in the dose levels which have been cleared and deemed safe by SMC to further evaluate the safety, tolerability and PK. This is referred to as backfilling.
Part 2 (Phase Ib):
This is a dose expansion phase to further evaluate the safety, tolerability and preliminary anti-tumor activity of YL 17231 at the RP2D selected by SMC.
The number of patients to be enrolled for the expansion cohorts, the RP2D and the desired patient population will be determined by the emerging data from part 1 of the study, including safety, tolerability, PK, PD and preliminary anti-tumor efficacy, as well as any other relevant evolving clinical data, and will be clarified through a protocol amendment.
- Conditions
- Advanced Solid Tumors
- Being tested
- YL-17231
- Keywords
- KRAS, HRAS, or NRAS Mutations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YL-17231Drug
YL-17231 will be administered orally once daily in a continuous regimen
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation and Expansion | Experimental | Dose escalation of YL-17231 to determine maximum tolerated dose.Expansion cohort to ensure sufficient safety experience, pharmacokinetic information, and early evidence of clinical activity of YL-17231 to recommend Phase 2 regimens Receives: Drug: YL-17231 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of dose limiting toxicities (DLTs)
A toxicity will be considered dose-limiting if it occurs during the first cycle (21 days) of treatment with YL-17231.
Measured: The first cycle (21 days)
TEAEs
AEs will be coded using Medical Dictionary for Regulatory Activities current version. AEs will be regarded as treatment-emergent AEs (TEAEs) if they occur after first treatment. The frequencies will be presented including number and percentages of patients having experienced an event and the total number of events.
Measured: Through study completion, an average of 1 year
SAEs
Serious AEs
Measured: Through study completion, an average of 1 year
Secondary outcomes (8)
Overall Response Rate (ORR)
ORR, defined as percentage of patients with a documented CR or PR in Response Evaluation Criteria in Solid Tumors 1.1(RECIST 1.1)
Measured: From first dose of study treatment to the first documented disease progression or death due to any cause, whichever occurs first， assessed up to 30 months.
Duration of Response (DOR)
DOR, defined as time from first documentation of a response (PR or CR) to the first documented disease progression or death due to any cause, whichever occurs first, for those patients with a PR or CR.
Measured: From first documentation of a response (PR or CR) to the first documented disease progression or death due to any cause, whichever occurs first， assessed up to 30 months.
Progression Free Survival (PFS)
PFS, defined as time from first dose of study treatment to the first documented disease progression or death due to any cause, whichever occurs first.
Measured: From first dose of study treatment to the first documented disease progression or death due to any cause, whichever occurs first, assessed up to 30 months.
Disease Control Rate (DCR)
DCR, defined as percentage of patients with a documented CR or PR and SD
Measured: From first dose of study treatment to the first documented disease progression or death due to any cause, whichever occurs first, assessed up to 30 months.
AUC(0-T)
Area under the concentration-time curve from time zero to the last quantifiable concentration of YL-17231
Measured: During Cycles 1 and 2 (each cycle is 21 days)
Cmax
Maximum observed serum concentration of YL-17231 is observed directly from data
Measured: During Cycles 1 and 2 (each cycle is 21 days)
T1/2
Elimination half life of YL-17231 is observed directly from data
Measured: During Cycles 1 and 2 (each cycle is 21 days)
Tmax
Time to maximum plasma concentration of YL-17231 is observed directly from data as time of Cmax
Measured: During Cycles 1 and 2 (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start24 Oct 2023
- Primary completionOct 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai YingLi Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06096974
- Sponsor's protocol ID
- YL-17231-001
- Status last verified
- Apr 2025
- First submitted
- 18 Oct 2023
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- 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 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Open-Label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of Pan-RAS Inhibitor YL-17231 in Patients With Advanced Solid Tumors Harboring Mutations in KRAS, HRAS, or NRAS
- ClinicalTrials.gov ID
- NCT06096974
- Acronym / sponsor ID
- YL-17231-001
- Conditions
- Advanced Solid Tumors
- Keywords
- KRAS, HRAS, or NRAS Mutations
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai YingLi Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 24 Oct 2023 (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.
This study will evaluate the safety, tolerability, drug levels, pharmacodynamic effects, and clinical activity of YL 17231 in patients with advanced solid tumors harboring mutations in KRAS, HRAS, or NRAS.
Detailed description
The study is a Phase 1, multi-center, open label study in 2 parts.
Part 1 (Phase Ia):
This is a 3 + 3 design dose escalation study, to evaluate the safety and tolerability, and to determine the MTD and/or RP2D of YL-17231 treatment when administered orally QD in patients with advanced solid tumors harboring mutations in KRAS, HRAS or NRAS. Up to 9 doses cohorts are planned for the dose escalation part of the study, with the starting dose of 0.25mg QD. The actual number of dose cohorts to be explored in this study will be determined by the non-tolerable dose based on dose limiting toxicities (DLTs) in conjunction with the PK and preliminary efficacy signal data. If suggested by safety and PK findings from planned dose treatment cohorts, additional dose levels may be evaluated and dosing interval may be modified under the Safety Monitoring Committee (SMC) guidance.
In Part 1, the 3+3 trial design for the dose escalation will be used and a total of 9 dose levels starting dose of 0.25 mg OD is planned.
One cycle is 21 days. DLT observation period is one cycle. The maximum tolerated dose (MTD) is the highest dose at which ≤1 of 6 patients experiences a DLT during the DLT observation period. The study will identify a maximum tolerated dose (MTD) if possible, with safety and tolerability data. All available data, including safety, tolerability, PK, PD and preliminary anti-tumor activity from each cohort will be reviewed by the SMC to determine the RP2D.
Patients may be permitted an intra-patient dose-escalation of YL-17231 to a higher dose level that has been cleared and deemed safe by the SMC if they have completed Cycle 2 at their initial enrolled dose level and continued on-study with no treatment related ≥ Grade 2 AEs. The Investigator must consult with the Medical Monitor to confirm if the patient is permitted be dose-escalated to a dose-level already cleared by the SMC.
Backfilling Additional patients (up to total of 12) may be enrolled in the dose levels which have been cleared and deemed safe by SMC to further evaluate the safety, tolerability and PK. This is referred to as backfilling.
Part 2 (Phase Ib):
This is a dose expansion phase to further evaluate the safety, tolerability and preliminary anti-tumor activity of YL 17231 at the RP2D selected by SMC.
The number of patients to be enrolled for the expansion cohorts, the RP2D and the desired patient population will be determined by the emerging data from part 1 of the study, including safety, tolerability, PK, PD and preliminary anti-tumor efficacy, as well as any other relevant evolving clinical data, and will be clarified through a protocol amendment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation and Expansion | Experimental | Drug: YL-17231Dose escalation of YL-17231 to determine maximum tolerated dose.Expansion cohort to ensure sufficient safety experience, pharmacokinetic information, and early evidence of clinical activity of YL-17231 to recommend Phase 2 regimens |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Unresectable or metastatic advanced solid tumors with no standard therapies, or having progressed on or intolerable to standard therapies.
- Advanced solid tumors harboring mutations in KRAS, HRAS or NRAS as determined by laboratory testing, including local laboratory testing.
- Measurable disease with at least one lesion amenable to response assessment per RECIST 1.1.
- Demonstrate adequate organ function as defined below. All screening laboratories should be performed within 7 days of study treatment initiation.
- 1）Absolute neutrophil count (ANC) ≥1.2 × 10^9/L；2）Platelets ≥100 × 10^9/L Hemoglobin ≥9 g/dL or ≥5.6 mmol/L；3）Measured or calculated creatinine clearance (CrCl)(Cockcroft-Gault) ≥60 mL/min；4）Total bilirubin ≤1.5 × ULN (patients with Gilbert's syndrome, total bilirubin ≤3.0 × ULN) ；5）Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN or ≤5 × ULN for patients with liver metastases
Key exclusion criteria (19 listed)
- Known symptomatic brain metastases requiring dexamethasone ≥4mg (or equivalent) or requiring steroid dose increase within 14 days prior to the first dose of YL-17231.
- Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment.
- Unresolved toxicities from prior therapy, defined as having not resolved to NCI CTCAE v.5.0 Grade ≤1 1 or baseline, with exception of endocrinopathies from prior therapy and successfully treated (such as hypothyroidism), alopecia, vitiligo, and ≤ grade 2 peripheral neuropathy.
- Human immunodeficiency virus (HIV) infection with a current or a known history of AIDS-defining illness or HIV infection with a CD4+ T cell count <350 cells/µL and an HIV viral load more than 400 copies/µL.
- Patients with active viral (any etiology) hepatitis are excluded. However, patients with serologic evidence of chronic hepatitis B virus (HBV) infection (defined by a positive hepatitis B surface antigen test and a positive anti-hepatitis core antigen antibody test) who have a viral load below the limit quantification (HBV DNA titer <1000 cps/mL or 200 IU/mL), and are not currently on viral suppressive therapy may be eligible and should be discussed with the Medical Monitor. Patients with a history of hepatitis C virus (HCV) infection who have completed curative antiviral treatment and have a viral load below the limit of quantitation may be eligible and should be discussed with the Medical Monitor.
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 |
|---|---|---|
| YL-17231YL-17231 will be administered orally once daily in a continuous regimen | Drug | Dose Escalation and Expansion |
Primary outcome
Occurrence of dose limiting toxicities (DLTs)
Time frame: The first cycle (21 days)
A toxicity will be considered dose-limiting if it occurs during the first cycle (21 days) of treatment with YL-17231.
TEAEs
Time frame: Through study completion, an average of 1 year
AEs will be coded using Medical Dictionary for Regulatory Activities current version. AEs will be regarded as treatment-emergent AEs (TEAEs) if they occur after first treatment. The frequencies will be presented including number and percentages of patients having experienced an event and the total number of events.
SAEs
Time frame: Through study completion, an average of 1 year
Serious AEs
8 secondary outcomes
Overall Response Rate (ORR)
Time frame: From first dose of study treatment to the first documented disease progression or death due to any cause, whichever occurs first， assessed up to 30 months.
Duration of Response (DOR)
Time frame: From first documentation of a response (PR or CR) to the first documented disease progression or death due to any cause, whichever occurs first， assessed up to 30 months.
Progression Free Survival (PFS)
Time frame: From first dose of study treatment to the first documented disease progression or death due to any cause, whichever occurs first, assessed up to 30 months.
Disease Control Rate (DCR)
Time frame: From first dose of study treatment to the first documented disease progression or death due to any cause, whichever occurs first, assessed up to 30 months.
AUC(0-T)
Time frame: During Cycles 1 and 2 (each cycle is 21 days)
Cmax
Time frame: During Cycles 1 and 2 (each cycle is 21 days)
T1/2
Time frame: During Cycles 1 and 2 (each cycle is 21 days)
Tmax
Time frame: During Cycles 1 and 2 (each cycle is 21 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing YL-17231 in people with Advanced Solid Tumors, run by Shanghai YingLi Pharmaceutical Co. Ltd. at 3 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 13 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David S. Hong, MD ((713) 563-1930, dshong@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of dose limiting toxicities (DLTs) (time frame: The first cycle (21 days)). The study lists 3 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 9 Apr 2025.