Solid TumorPhase 1NCT06797336
A Study of PT0253 in Participants With KRAS G12D Mutated Advanced Solid Tumors
A Phase 1 study testing PT0253, Chemotherapy Combination 1 and Chemotherapy Combination 2 in people with Solid Tumor, run by PAQ Therapeutics, Inc. at 15 sites in 2 countries.
Trial summary
The primary purpose of this study is to evaluate the safety and tolerability, determine the maximally tolerated dose (MTD) and/or recommended Phase 2 dose(s) (RP2D) of PT0253 in adult participants with Kirsten rat sarcoma viral oncogene homolog (KRAS) G12D mutated advanced solid tumors as monotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- PT0253, Chemotherapy Combination 1 and Chemotherapy Combination 2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 19 Dec 2024to 16 Jun 2027
- 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
- Histologically or cytologically confirmed advanced or metastatic solid malignancy
- Participant has a pathologically documented, locally advanced or metastatic malignancy with KRAS p.G12D mutation identified through molecular testing using a Clinical Laboratory Improvement Amendments (CLIA) certified, validated institutional or commercial test.
- Measurable disease (RECIST 1.1 Criteria).
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
- Willingness to avoid pregnancy or fathering children from screening through 90 days after the last dose of study treatment.
Who cannot join
- Active brain metastasis or carcinomatous meningitis. If participants have had brain metastases resected or have received radiation therapy, they may be eligible if: (1) study treatment begins at least 4 weeks from the end of brain-specific therapy, (2) residual neurological symptoms Grade less than or equal to (<=) 2, (3) currently on stable doses of corticosteroids, and (4) pre-study brain magnetic resonance imaging (MRI) documents no new/worsening brain lesions.
- History of any other malignancy within the past 2 years, except:
- Malignancy treated with curative intent and with no known active disease present >=2 years before enrolment and felt to be at low risk for recurrence by the investigator
- Basal or squamous cell carcinoma of the skin, in situ cervical cancer, early -stage endometrial cancer that has been definitively treated, superficial bladder cancer, Gleason 6/7 treated prostate cancer, and ductal carcinoma in situ or lobular carcinoma in situ of the breast.
- Unresolved toxicities from prior anti-cancer therapies (Common Terminology Criteria for Adverse Events [CTCAE] grades >1), except for alopecia. Grade <=2 toxicities from prior anti-tumor therapies that are considered irreversible may be allowed, provided that they are not described in the exclusion criteria AND the investigator and medical monitor are in agreement to proceed.
- Concurrent participation in another interventional clinical study.
Show all 28Show fewer
- Treatment with anticancer medications or investigational drugs within the following intervals before the first administration of study drug:
- At least 14 days for chemotherapy or targeted small-molecule therapy.
- At least 28 days for a prior monoclonal antibody
- At least 4 months for checkpoint inhibitors
- At least 4 months for antibody-drug conjugates
- At least 28 days or 5 half-lives (whichever is longer) for all other investigational study drugs or devices. For drugs with very long half-lives, participants may be allowed to enroll prior to 5 half-lives at the discretion of the investigator in discussion with the medical monitor. Note: Concurrent hormonal therapy for prostate or breast cancer is allowable.
- Thoracic radiation within 4 months of starting study therapy.
- Significant cardiovascular disease within 6 months of starting study therapy.
- Active infection requiring antibiotics within 1 day of study treatment.
- History of non-infectious interstitial lung disease (ILD) or pneumonitis.
- Known HIV infection with a cluster of differentiation 4+ (CD4+) T-cell count less than (<) 200 cells per microliter [/mcL] and/or a detectable viral load per parameters of assay and/or on an anti-retroviral regimen containing a strong or moderate cytochrome (CY)P3A4/5 inhibitor or inducer and/or on a new anti-retroviral regimen for less than 28 days prior to the initiation of study treatment.
- Known history of drug-induced liver injury; primary biliary cirrhosis; or ongoing extrahepatic obstruction caused by stones, cirrhosis of the liver, or portal hypertension.
- Major surgery within 4 weeks of the start of study therapy or postoperative complications preventing the participant from adhering to protocol assessments and procedures.
- Known hypersensitivity to any of the products to be administered during dosing.
- Any disease or disorder that, in the opinion of the investigator, may compromise the ability of the participant to provide written informed consent and/or to comply with all required study procedures.
- Part 1a (Dose escalation): Use of a strong or moderate CYP3A4/5 inhibitor or inducer, strong P-glycoprotein (P-gp) inhibitor or inducer or P-gp substrate.
- Use of multidrug and toxin extrusion protein 1 (MATE) or MATE2-K substrates that cannot be discontinued prior to the start of study treatment.
- Participants with laboratory values indicating inadequate hematology, hepatic, or renal function.
- Clinically significant abnormalities in rhythm, conduction, or morphology of resting electrocardiogram (ECG) or baseline QT interval corrected for heart rate using Fridericia's formula (QTcF) >=450 milliseconds (msec).
- Female participants who are pregnant or lactating/breast feeding or who plan to breastfeed while on study through 28 days after receiving the last dose of study drug.
- Active hepatitis B virus (HBV) infection. Participants with resolved infection or who are on stable antiviral therapy are eligible.
- Active hepatitis C virus (HCV) infection. Participants who have completed definitive antiviral therapy with post treatment confirmation of eradication are eligible.
Trial locations and contacts
15 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
15 sites in 2 countries
United States9 sites, 7 recruiting
- Recruiting
Dana Farber/Massachusetts General Hospital, Inc
Boston, Massachusetts, 02215
857-367-1486, lpappas3@mgb.org
Leon Pappas, MD
- Recruiting
NEXT Virginia
Fairfax, Virginia, 22031
703-783-4510, aspira@nextoncology.com
Alexander Spira, MD
- Recruiting
START Midwest
Grand Rapids, Michigan, 49546
616- 954-5554, manish.sharma@startresearch.com
Manish Sharma
- Recruiting
START Los Angeles
Los Angeles, California, 90025
424-465-1820, navid.hafez@startresearch.com
Navid Hafez
- Withdrawn
SCRI Lake Mary
Nashville, Tennessee, 37203
- Withdrawn
SCRI Oncology Partners
Nashville, Tennessee, 37203
- Recruiting
New Experimental Therapeutics of San Antonio LLC
San Antonio, Texas, 78229
(210) 580-9500, atolcher@nextoncology.com
Dr. Anthony Tolcher
- Recruiting
START - South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, 78229
(210) 593-5700, drasco@startsa.com
Dr. Drew Rasco, MD
- Recruiting
START Mountain Region
West Valley City, Utah, 84119
2105809500, william.mckean@startresearch.com
Dr. William McKean, MD
South Korea6 sites, 6 recruiting
- Recruiting
CHA University Bundang Medical Center
Seongnam
82-10-8556-7223, hongjaechon@gmail.com
Hongjae Chon
- Recruiting
Asan Medical Center
Seoul
+82-2-3010-6981, changhm@amc.seoul.kr
Heung-Moon Chang
- Recruiting
Samsung Medical Center
Seoul
82-2-3410-3459, oncopark@skku.edu
Joon Oh Park
- Recruiting
Seoul National University Bundang Hospital
Seoul
kimjw05@snu.ac.kr
Jin Won Kim
- Recruiting
Seoul National University Hospital
Seoul
82-2-2072-0701, Oohdoyoun@snu.ac.kr
Do-Youn Oh
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul
82-2-2228-8133, choihj@yuhs.ac
Hye Jin Choi
About this study
Official title: A Phase 1, Open-Label Dose Escalation and Expansion Study of PT0253 in Participants With KRAS G12D Mutated Advanced Solid Tumors
The primary purpose of this study is to evaluate the safety and tolerability, determine the maximally tolerated dose (MTD) and/or recommended Phase 2 dose(s) (RP2D) of PT0253 in adult participants with Kirsten rat sarcoma viral oncogene homolog (KRAS) G12D mutated advanced solid tumors as monotherapy.
- Conditions
- Solid Tumor
- Being tested
- PT0253, Chemotherapy Combination 1, Chemotherapy Combination 2, Chemotherapy Combination 3, Cetuximab
- Keywords
- KRAS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PT0253Drug
PT0253 injection.
Chemotherapy Combination 1Drug
Intravenous infusion.
Chemotherapy Combination 2Drug
Intravenous infusion.
Chemotherapy Combination 3Drug
Intravenous infusion.
CetuximabDrug
Intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| Part 1a, Dose Escalation | Experimental | Participants with any type of solid tumor will receive PT0253 injection, intravenously (IV) until disease progression or intolerance. Receives: Drug: PT0253 |
| Part 1b, Dose Expansion: Tumor type 1 | Experimental | Participants with a previously treated tumor type will receive PT0253 injection in combination with intravenous infusion of Chemotherapy Combination 1 until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) data for PT0253 established in Part 1a. Receives: Drug: PT0253; Drug: Chemotherapy Combination 1 |
| Part 1b, Dose Expansion: Tumor type 2 | Experimental | Participants with a previously treated tumor type will receive PT0253 injection in combination with intravenous infusion of Chemotherapy Combination 2 until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, PK and PD data for PT0253 established in Part 1a. Receives: Drug: PT0253; Drug: Chemotherapy Combination 2 |
| Part 1b, Dose Expansion: Tumor type 3 | Experimental | Participants with a previously treated tumor type will receive PT0253 injection in combination with intravenous infusion of Cetuximab until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, PK and PD data for PT0253 established in Part 1a. Receives: Drug: PT0253; Drug: Cetuximab |
| Part 1b, Dose Expansion: Tumor type 4 | Experimental | Participants with a previously treated tumor type will receive PT0253 injection in combination with intravenous infusion of Chemotherapy Combination 3 until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, PK and PD data for PT0253 established in Part 1a. Receives: Drug: PT0253; Drug: Chemotherapy Combination 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Dose-limiting Toxicities (DLT)
Measured: Cycle 1 (Cycle length=21 days)
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Measured: Up to 24 months
Number of Participants with TEAEs Leading to Treatment Interruptions, Dose Reductions and Permanent Discontinuations
Measured: Up to 24 months
Secondary outcomes (11)
Cmax/C0: Maximum Blood Concentration (Cmax) and/or Concentration at Time 0 (C0) of PT0253
Measured: Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days)
Tmax: Time to Reach Cmax of PT0253
Measured: Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days)
AUC0-t: Area Under the Curve From time 0 to the time of the Last Quantifiable Concentration of PT0253
Measured: Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days)
t1/2: Terminal Elimination Half-life of PT0253
Measured: Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days)
AUC0-∞: Area Under the Curve From Time 0 Extrapolated to Infinity of PT0253
Measured: Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days)
CL: Clearance of PT0253
Measured: Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days)
Vd: Volume of Distribution of PT0253
Measured: Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days)
Overall Response Rate (ORR)
ORR will be determined by radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Measured: Up to 24 months
Duration of Response (DOR)
DOR will be determined by radiographic disease assessments per RECIST 1.1.
Measured: Up to 24 months
Overall Survival (OS)
OS is defined as the time from enrollment up to death due to any cause.
Measured: At 1 year
Progression-free Survival (PFS)
PFS will be determined by radiographic disease assessments per RECIST 1.1.
Measured: At 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start19 Dec 2024
- Primary completion15 Dec 2026 (estimated)
- Study completion16 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PAQ Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06797336
- Sponsor's protocol ID
- PT0253-101
- Status last verified
- Aug 2026
- First submitted
- 22 Jan 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Dose Escalation and Expansion Study of PT0253 in Participants With KRAS G12D Mutated Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06797336
- Acronym / sponsor ID
- PT0253-101
- Conditions
- Solid Tumor
- Keywords
- KRAS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- PAQ Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 16 Jun 2027 (estimated)
- First posted
- 28 Jan 2025 (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 primary purpose of this study is to evaluate the safety and tolerability, determine the maximally tolerated dose (MTD) and/or recommended Phase 2 dose(s) (RP2D) of PT0253 in adult participants with Kirsten rat sarcoma viral oncogene homolog (KRAS) G12D mutated advanced solid tumors as monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1a, Dose Escalation | Experimental | Drug: PT0253Participants with any type of solid tumor will receive PT0253 injection, intravenously (IV) until disease progression or intolerance. |
| Part 1b, Dose Expansion: Tumor type 1 | Experimental | Drug: PT0253, Drug: Chemotherapy Combination 1Participants with a previously treated tumor type will receive PT0253 injection in combination with intravenous infusion of Chemotherapy Combination 1 until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) data for PT0253 established in Part 1a. |
| Part 1b, Dose Expansion: Tumor type 2 | Experimental | Drug: PT0253, Drug: Chemotherapy Combination 2Participants with a previously treated tumor type will receive PT0253 injection in combination with intravenous infusion of Chemotherapy Combination 2 until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, PK and PD data for PT0253 established in Part 1a. |
| Part 1b, Dose Expansion: Tumor type 3 | Experimental | Drug: PT0253, Drug: CetuximabParticipants with a previously treated tumor type will receive PT0253 injection in combination with intravenous infusion of Cetuximab until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, PK and PD data for PT0253 established in Part 1a. |
| Part 1b, Dose Expansion: Tumor type 4 | Experimental | Drug: PT0253, Drug: Chemotherapy Combination 3Participants with a previously treated tumor type will receive PT0253 injection in combination with intravenous infusion of Chemotherapy Combination 3 until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, PK and PD data for PT0253 established in Part 1a. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically confirmed advanced or metastatic solid malignancy
- Participant has a pathologically documented, locally advanced or metastatic malignancy with KRAS p.G12D mutation identified through molecular testing using a Clinical Laboratory Improvement Amendments (CLIA) certified, validated institutional or commercial test.
- Measurable disease (RECIST 1.1 Criteria).
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
- Willingness to avoid pregnancy or fathering children from screening through 90 days after the last dose of study treatment.
Key exclusion criteria (28 listed)
- Active brain metastasis or carcinomatous meningitis. If participants have had brain metastases resected or have received radiation therapy, they may be eligible if: (1) study treatment begins at least 4 weeks from the end of brain-specific therapy, (2) residual neurological symptoms Grade less than or equal to (<=) 2, (3) currently on stable doses of corticosteroids, and (4) pre-study brain magnetic resonance imaging (MRI) documents no new/worsening brain lesions.
- History of any other malignancy within the past 2 years, except:
- Unresolved toxicities from prior anti-cancer therapies (Common Terminology Criteria for Adverse Events [CTCAE] grades >1), except for alopecia. Grade <=2 toxicities from prior anti-tumor therapies that are considered irreversible may be allowed, provided that they are not described in the exclusion criteria AND the investigator and medical monitor are in agreement to proceed.
- Concurrent participation in another interventional clinical study.
- Treatment with anticancer medications or investigational drugs within the following intervals before the first administration of study drug:
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 |
|---|---|---|
| PT0253PT0253 injection. | Drug | Part 1a, Dose Escalation, Part 1b, Dose Expansion: Tumor type 1, Part 1b, Dose Expansion: Tumor type 2, Part 1b, Dose Expansion: Tumor type 3, Part 1b, Dose Expansion: Tumor type 4 |
| Chemotherapy Combination 1Intravenous infusion. | Drug | Part 1b, Dose Expansion: Tumor type 1 |
| Chemotherapy Combination 2Intravenous infusion. | Drug | Part 1b, Dose Expansion: Tumor type 2 |
| Chemotherapy Combination 3Intravenous infusion. | Drug | Part 1b, Dose Expansion: Tumor type 4 |
| CetuximabIntravenous infusion. | Drug | Part 1b, Dose Expansion: Tumor type 3 |
Primary outcome
Number of Participants with Dose-limiting Toxicities (DLT)
Time frame: Cycle 1 (Cycle length=21 days)
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 24 months
Number of Participants with TEAEs Leading to Treatment Interruptions, Dose Reductions and Permanent Discontinuations
Time frame: Up to 24 months
11 secondary outcomes
Cmax/C0: Maximum Blood Concentration (Cmax) and/or Concentration at Time 0 (C0) of PT0253
Time frame: Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days)
Tmax: Time to Reach Cmax of PT0253
Time frame: Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days)
AUC0-t: Area Under the Curve From time 0 to the time of the Last Quantifiable Concentration of PT0253
Time frame: Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days)
t1/2: Terminal Elimination Half-life of PT0253
Time frame: Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days)
AUC0-∞: Area Under the Curve From Time 0 Extrapolated to Infinity of PT0253
Time frame: Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days)
CL: Clearance of PT0253
Time frame: Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days)
Vd: Volume of Distribution of PT0253
Time frame: Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days)
Overall Response Rate (ORR)
Time frame: Up to 24 months
Duration of Response (DOR)
Time frame: Up to 24 months
Overall Survival (OS)
Time frame: At 1 year
Progression-free Survival (PFS)
Time frame: At 1 year
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 7 Oct 2026.
- Individual participant dataSharing planned: Yes
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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.
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PT0253, Chemotherapy Combination 1 and Chemotherapy Combination 2 in people with Solid Tumor, run by PAQ Therapeutics, Inc. at 15 sites in 2 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 5 inclusion and 28 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 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, South Korea. 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 PAQ Therapeutics (781-819-2949, ClinicalTrials@paqtx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Dose-limiting Toxicities (DLT) (time frame: Cycle 1 (Cycle length=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 7 Oct 2026.