Advanced Solid TumorPhase 1NCT06242470
A Study of MGC026 in Participants With Advanced Solid Tumors
A Phase 1 study testing MGC026 Dose Escalation, MGC026 Dose for Expansion and Pembrollizumab in people with Advanced Solid Tumor and Advanced Cancer, run by MacroGenics at 12 sites in 3 countries.
Trial summary
The study is designed to understand the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of vobramitamab tavatecan (MGC026) in participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors The study has a dose escalation portion and a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Advanced Cancer, Metastatic Cancer
- What is being tested?
- MGC026 Dose Escalation, MGC026 Dose for Expansion and Pembrollizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 394 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 6 Mar 2024to Apr 2029
- 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
- Adults ≥ 18 years old, able to provide informed consent
- Adequate performance and laboratory parameters
- Availability of archival or formalin-fixed paraffin-embedded tumor tissue sample. Participants may undergo a fresh tumor biopsy to obtain a specimen for testing if an archival tumor sample is not available. Participants with no available archival tissue sample who cannot safely undergo a fresh biopsy as determined by consultation between the sponsor and investigator are eligible
- Unresectable, locally advanced or metastatic solid tumors including: squamous cell cancer (SCC) of the head and neck, esophageal SCC, squamous and non-squamous non-small cell lung cancer, small cell lung cancer, bladder cancer, sarcoma, endometrial cancer, melanoma, castration resistant prostate cancer, breast cancer, ovarian cancer, cervical cancer, colorectal cancer gastric or gastroesophageal cancer, pancreatic carcinoma, clear cell renal cell cancer or hepatocellular cancer.
- Measurable disease per RECIST v1.1. Participants with metastatic CRPC without measurable disease are eligible.
- Must be willing to use highly effective methods of birth control from the time of consent through 7 months after discontinuation of MGC026.
- Not pregnant or breastfeeding.
Who cannot join
- Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.
- Another cancer that required treatment within the past 2 years, with the exception of those with low risk of cancer spreading or death such as adequately treated non melanomatous skin cancer, localized prostate cancer (Gleason Score < 6), or carcinoma in situ.
- Patients with history of prior central nervous system (CNS) metastasis must have been treated, be asymptomatic, and not have concurrent treatment for CNS disease, progression of CNS metastases on magnetic resonance imaging, computed tomography or positron emission tomography, or history of leptomeningeal disease or cord compression at the time of enrollment.
- Treatment with surgery, systemic cancer therapy, immunotherapy, chimeric antigen receptor-T therapy, or anti-hormonal within protocol specified intervals.
- Prior treatment with any B7-H3 targeted agent for cancer or any ADC with a topoisomerase payload.
- Prior autologous or allogeneic stem cell or solid organ transplant.
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- Clinically significant cardiovascular, pulmonary, or gastrointestinal disorders.
- Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 1 week of first study drug administration.
- Known history of hepatitis B or C infection or known positive test for hepatitis B surface antigen or core antigen, or hepatitis C polymerase chain reaction.
- Known positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome.
- History of primary immunodeficiency.
- Major trauma or major surgery within 4 weeks of first study drug administration.
- Known hypersensitivity to recombinant proteins.
Trial locations and contacts
12 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
12 sites in 3 countries
United States7 sites, 7 recruiting
- Recruiting
START Midwest
Grand Rapids, Michigan, 49546
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
University of Texas Health Science Center at Houston
Houston, Texas, 77030
- Recruiting
START-New York Long Island
Lake Success, New York, 11042
- Recruiting
The Angeles Clinic and Research Institute
Los Angeles, California, 90025
- Recruiting
Providence Cancer Institute
Portland, Oregon, 97213
- Recruiting
START Mountain Region
West Valley City, Utah, 84119
Australia3 sites, 3 recruiting
- Recruiting
ICON Cancer Centre Wesley
Auchenflower, Queensland, 4066
- Recruiting
Austin Health- Olivia Newton John Cancer Center
Heidelberg, Victoria, 3084
- Recruiting
ICON Cancer Centre Kurralta Park
Kurralta Park, South Australia, 5037
United Kingdom2 sites, 2 recruiting
- Recruiting
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 9DU
- Recruiting
The Royal Marsden NHS Foundation Trust
Sutton, SM2 5PT
About this study
Official title: A Phase 1/1b First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 in Participants With Advanced Solid Tumors
The study is designed to understand the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of vobramitamab tavatecan (MGC026) in participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors The study has a dose escalation portion and a cohort expansion portion in Module A of the study. Combination therapy with pembrolizumab will occur in Module B of the study Participants will receive vobramitamab tavatecan by intravenous (IV) infusion. The dose of vobramitamab tavatecan will be assigned at the time of enrollment. Pembrolizumab will be administered at 200 mg every 3 weeks. Participants may receive up to 35 treatments if there are no severe side effects and as long as the cancer does not get worse. Participants will be monitored for side effects, and progression of cancer, have blood samples collected for routing laboratory work, and blood and tumor samples collected for research purposes.
- Conditions
- Advanced Solid Tumor, Advanced Cancer, Metastatic Cancer, Squamous Cell Carcinoma of Head and Neck, Non Small Cell Lung Cancer, Small-cell Lung Cancer
- Being tested
- MGC026 Dose Escalation, MGC026 Dose for Expansion, Pembrollizumab, vobramitamab tavatecan
- Medical subject headings
- Neoplasm Metastasis, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Urinary Bladder Neoplasms, Sarcoma, Endometrial Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MGC026 Dose EscalationBiological
Escalating doses of MGC026
MGC026 Dose for ExpansionBiological
MGC026 recommended dose for expansion
PembrollizumabBiological
Also called Keytruda
200 mg, IV, every 3 weeks.
vobramitamab tavatecanBiological
less than RDE dose level, IV, every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Module A Cohort 1 | Experimental | MGC026 is a topoisomerase 1 inhibitor (TOP1i)-based ADC that targets B7-H3 administered IV every 3 weeks. Receives: Biological: MGC026 Dose Escalation |
| Module A Cohort 2 | Experimental | Not described Receives: Biological: MGC026 Dose Escalation |
| Module A Cohort 3 | Experimental | Not described Receives: Biological: MGC026 Dose Escalation |
| Module A Cohort 4 | Experimental | Not described Receives: Biological: MGC026 Dose Escalation |
| Module A Cohort 5 | Experimental | Not described Receives: Biological: MGC026 Dose Escalation |
| Module A Cohort 6 | Experimental | Not described Receives: Biological: MGC026 Dose Escalation |
| Module A Expansion cohort 1 | Experimental | Not described Receives: Biological: MGC026 Dose for Expansion |
| Module A Expansion cohort 2 | Experimental | Not described Receives: Biological: MGC026 Dose for Expansion |
| Module A Expansion cohort 3 | Experimental | Not described Receives: Biological: MGC026 Dose for Expansion |
| Module A Expansion cohort 4 | Experimental | Not described Receives: Biological: MGC026 Dose for Expansion |
| Module A Expansion Cohort 5 | Experimental | Not described Receives: Biological: MGC026 Dose for Expansion |
| Module A Expansion Cohort 6 | Experimental | Not described Receives: Biological: MGC026 Dose for Expansion |
| Module A Expansion Cohort 7 | Experimental | Not described Receives: Biological: MGC026 Dose for Expansion |
| Module A Expansion Cohort 8 | Experimental | Not described Receives: Biological: MGC026 Dose for Expansion |
| Module B Part 1, Dose Level 1 | Experimental | Not described Receives: Biological: Pembrollizumab; Biological: vobramitamab tavatecan |
| Module B Part 1, Dose Level 2 | Experimental | Module B Part 2, Dose Expansion Receives: Biological: MGC026 Dose for Expansion; Biological: Pembrollizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs) and serious AEs (SAEs), AEs leading to dose delay, AEs leading to dose reduction, AEs leading to treatment discontinuations, AEs meeting criteria for dose limiting toxicity, and AEs of special interest.
Measured: Throughout the study, up to 135 weeks
Secondary outcomes (9)
Overall response rate in advanced solid tumors
The objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) is used to estimate the proportion of participants in the Response Evaluable population who achieve best overall response of complete response (CR) or partial response (PR) (called responders).
Complete response (CR) is defined as disappearance of all target and non-target lesions.
Partial response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, no progression of non-target lesions, and no new lesions
Measured: Throughout the study, up to 135 weeks
Duration of response (DoR) in advanced solid tumors
DoR is defined as the time from the date of initial response (CR or PR) to the date of first documented progression or death from any cause, whichever occurs first. (RECIST 1.1) is used to classify responses.
Measured: Throughout the study, up to 135 weeks
ORR rate in metastatic castration resistant prostate cancer (mCRPC)
The ORR per Prostate Cancer Working Group 3 (PCWG3) criteria is estimated as the proportion of participants in the Response Evaluable population who achieve best overall response of CR or PR (called responders).
Measured: Throughout the study, up to 135 weeks
DoR in mCRPC
DoR is defined as the time from the date of initial response (CR or PR) to the date of first documented progression, per PCWG3 criteria or death from any cause, whichever occurs first.
Measured: Throughout the study, up to 135 weeks
Mean (standard deviation [SD]) of vobramitamab tavatecan total and conjugated antibody maximum serum concentration (Cmax)
The maximum concentration in the bloodstream at the end of the infusion.
Measured: Cycle 1 Day 1: at baseline, end of infusion (EOI) approximately 1 hr, 4hrs after EOI, Day 2 and Day 4.
Mean (standard deviation [SD]) of vobramitamab tavatecan unconjugated payload Cmax
The maximum concentration in the bloodstream at the end of the infusion.
Measured: Cycle 1 Day 1: at baseline, end of infusion (EOI) approximately 1 hr, 4hrs after EOI, Day 2 and Day 4.
Mean (SD) of vobramitamab tavatecan total and conjugated antibody area under the time concentration curve (AUC)
Calculated exposure to MGC026
Measured: Cycle 1 Day 1: at baseline, EOI approximately 1 hr, 4hrs after EOI, Day 2, Day 4, Day 8, Day 15, and predose Cycle 2 Day 1
Mean (SD) of vobramitamab tavatecan unconjugated payload AUC
Calculated exposure to MGC026
Measured: Cycle 1 Day 1: at baseline, EOI approximately 1 hr, 4hrs after EOI, Day 2, Day 4, Day 8, Day 15, and predose Cycle 2 Day 1
Number of participants who develop anti-vobramitamab tavatecan antibodies (immunogenicity)
Development of anti-MGC026 antibodies in the bloodstream
Measured: Day 1, Day 15, and Day 1 of every 21-day cycle, throughout the study, average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start6 Mar 2024
- Primary completionOct 2028 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 394 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MacroGenics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yiyun Dai, MD, PhD, Study director, MacroGenics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242470
- Sponsor's protocol ID
- CP-MGC026-01
- Status last verified
- Oct 2026
- First submitted
- 12 Jan 2024
- Last updated
- 28 Oct 2026
- 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 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/1b First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06242470
- Acronym / sponsor ID
- CP-MGC026-01
- Conditions
- Advanced Solid Tumor, Advanced Cancer, Metastatic Cancer, Squamous Cell Carcinoma of Head and Neck, Non Small Cell Lung Cancer, Small-cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 394 participants (estimated)
- Lead sponsor
- MacroGenicsIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 5 Feb 2024 (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 study is designed to understand the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of vobramitamab tavatecan (MGC026) in participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors The study has a dose escalation portion and a cohort expansion portion in Module A of the study. Combination therapy with pembrolizumab will occur in Module B of the study Participants will receive vobramitamab tavatecan by intravenous (IV) infusion. The dose of vobramitamab tavatecan will be assigned at the time of enrollment. Pembrolizumab will be administered at 200 mg every 3 weeks. Participants may receive up to 35 treatments if there are no severe side effects and as long as the cancer does not get worse. Participants will be monitored for side effects, and progression of cancer, have blood samples collected for routing laboratory work, and blood and tumor samples collected for research purposes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Module A Cohort 1 | Experimental | Biological: MGC026 Dose EscalationMGC026 is a topoisomerase 1 inhibitor (TOP1i)-based ADC that targets B7-H3 administered IV every 3 weeks. |
| Module A Cohort 2 | Experimental | Biological: MGC026 Dose Escalation |
| Module A Cohort 3 | Experimental | Biological: MGC026 Dose Escalation |
| Module A Cohort 4 | Experimental | Biological: MGC026 Dose Escalation |
| Module A Cohort 5 | Experimental | Biological: MGC026 Dose Escalation |
| Module A Cohort 6 | Experimental | Biological: MGC026 Dose Escalation |
| Module A Expansion cohort 1 | Experimental | Biological: MGC026 Dose for Expansion |
| Module A Expansion cohort 2 | Experimental | Biological: MGC026 Dose for Expansion |
| Module A Expansion cohort 3 | Experimental | Biological: MGC026 Dose for Expansion |
| Module A Expansion cohort 4 | Experimental | Biological: MGC026 Dose for Expansion |
| Module A Expansion Cohort 5 | Experimental | Biological: MGC026 Dose for Expansion |
| Module A Expansion Cohort 6 | Experimental | Biological: MGC026 Dose for Expansion |
| Module A Expansion Cohort 7 | Experimental | Biological: MGC026 Dose for Expansion |
| Module A Expansion Cohort 8 | Experimental | Biological: MGC026 Dose for Expansion |
| Module B Part 1, Dose Level 1 | Experimental | Biological: Pembrollizumab, Biological: vobramitamab tavatecan |
| Module B Part 1, Dose Level 2 | Experimental | Biological: MGC026 Dose for Expansion, Biological: PembrollizumabModule B Part 2, Dose Expansion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults ≥ 18 years old, able to provide informed consent
- Adequate performance and laboratory parameters
- Availability of archival or formalin-fixed paraffin-embedded tumor tissue sample. Participants may undergo a fresh tumor biopsy to obtain a specimen for testing if an archival tumor sample is not available. Participants with no available archival tissue sample who cannot safely undergo a fresh biopsy as determined by consultation between the sponsor and investigator are eligible
- Unresectable, locally advanced or metastatic solid tumors including: squamous cell cancer (SCC) of the head and neck, esophageal SCC, squamous and non-squamous non-small cell lung cancer, small cell lung cancer, bladder cancer, sarcoma, endometrial cancer, melanoma, castration resistant prostate cancer, breast cancer, ovarian cancer, cervical cancer, colorectal cancer gastric or gastroesophageal cancer, pancreatic carcinoma, clear cell renal cell cancer or hepatocellular cancer.
- Measurable disease per RECIST v1.1. Participants with metastatic CRPC without measurable disease are eligible.
Key exclusion criteria (13 listed)
- Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.
- Another cancer that required treatment within the past 2 years, with the exception of those with low risk of cancer spreading or death such as adequately treated non melanomatous skin cancer, localized prostate cancer (Gleason Score < 6), or carcinoma in situ.
- Patients with history of prior central nervous system (CNS) metastasis must have been treated, be asymptomatic, and not have concurrent treatment for CNS disease, progression of CNS metastases on magnetic resonance imaging, computed tomography or positron emission tomography, or history of leptomeningeal disease or cord compression at the time of enrollment.
- Treatment with surgery, systemic cancer therapy, immunotherapy, chimeric antigen receptor-T therapy, or anti-hormonal within protocol specified intervals.
- Prior treatment with any B7-H3 targeted agent for cancer or any ADC with a topoisomerase payload.
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 |
|---|---|---|
| MGC026 Dose EscalationEscalating doses of MGC026 | Biological | Module A Cohort 1, Module A Cohort 2, Module A Cohort 3, Module A Cohort 4, Module A Cohort 5, Module A Cohort 6 |
| MGC026 Dose for ExpansionMGC026 recommended dose for expansion | Biological | Module A Expansion Cohort 5, Module A Expansion Cohort 6, Module A Expansion Cohort 7, Module A Expansion Cohort 8, Module A Expansion cohort 1, Module A Expansion cohort 2, Module A Expansion cohort 3, Module A Expansion cohort 4, Module B Part 1, Dose Level 2 |
| PembrollizumabAlso: Keytruda200 mg, IV, every 3 weeks. | Biological | Module B Part 1, Dose Level 1, Module B Part 1, Dose Level 2 |
| vobramitamab tavatecanless than RDE dose level, IV, every 3 weeks | Biological | Module B Part 1, Dose Level 1 |
Primary outcome
Number of participants with adverse events (AEs) and serious AEs (SAEs), AEs leading to dose delay, AEs leading to dose reduction, AEs leading to treatment discontinuations, AEs meeting criteria for dose limiting toxicity, and AEs of special interest.
Time frame: Throughout the study, up to 135 weeks
9 secondary outcomes
Overall response rate in advanced solid tumors
Time frame: Throughout the study, up to 135 weeks
Duration of response (DoR) in advanced solid tumors
Time frame: Throughout the study, up to 135 weeks
ORR rate in metastatic castration resistant prostate cancer (mCRPC)
Time frame: Throughout the study, up to 135 weeks
DoR in mCRPC
Time frame: Throughout the study, up to 135 weeks
Mean (standard deviation [SD]) of vobramitamab tavatecan total and conjugated antibody maximum serum concentration (Cmax)
Time frame: Cycle 1 Day 1: at baseline, end of infusion (EOI) approximately 1 hr, 4hrs after EOI, Day 2 and Day 4.
Mean (standard deviation [SD]) of vobramitamab tavatecan unconjugated payload Cmax
Time frame: Cycle 1 Day 1: at baseline, end of infusion (EOI) approximately 1 hr, 4hrs after EOI, Day 2 and Day 4.
Mean (SD) of vobramitamab tavatecan total and conjugated antibody area under the time concentration curve (AUC)
Time frame: Cycle 1 Day 1: at baseline, EOI approximately 1 hr, 4hrs after EOI, Day 2, Day 4, Day 8, Day 15, and predose Cycle 2 Day 1
Mean (SD) of vobramitamab tavatecan unconjugated payload AUC
Time frame: Cycle 1 Day 1: at baseline, EOI approximately 1 hr, 4hrs after EOI, Day 2, Day 4, Day 8, Day 15, and predose Cycle 2 Day 1
Number of participants who develop anti-vobramitamab tavatecan antibodies (immunogenicity)
Time frame: Day 1, Day 15, and Day 1 of every 21-day cycle, throughout the study, average of 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 28 Oct 2026.
- 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.
Yiyun Dai, MD, PhD study director
MacroGenics
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MGC026 Dose Escalation, MGC026 Dose for Expansion and Pembrollizumab in people with Advanced Solid Tumor and Advanced Cancer, run by MacroGenics at 12 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 7 inclusion and 13 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 28 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 12 sites in United States, Australia, 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 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 Global Trial Manager (301-251-5172, info@macrogenics.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 adverse events (AEs) and serious AEs (SAEs), AEs leading to dose delay, AEs leading to dose reduction, AEs leading to treatment discontinuations, AEs meeting criteria for dose limiting toxicity, and AEs of special interest. (time frame: Throughout the study, up to 135 weeks). 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 28 Oct 2026.