Advanced Solid TumorsPhase 1NCT05389462
A Study of Mipasetamab Uzoptirine (ADCT-601) in Participants With Solid Tumors
A Phase 1 study testing ADCT-601 and Gemcitabine in people with Advanced Solid Tumors, run by ADC Therapeutics S.A. at 14 sites in 4 countries.
Trial summary
The primary objective of this study is to identify the recommended phase 2 dose (RP2D) and/or the maximum tolerated dose (MTD), and characterize the safety and tolerability of ADCT-601 monotherapy and in combination with gemcitabine. 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?
- ADCT-601 and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 14 sitesin 4 countries
- Study dates
- 13 Jul 2022to 17 Apr 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participant aged 18 years or older.
- Pathologic diagnosis of solid tumor malignancy that is locally advanced or metastatic at time of screening:
- Part 1:
- Combination therapy arms: Selected sarcoma indications from the following 2 separate categories.
- Soft tissue sarcoma: leiomyosarcoma, liposarcoma, undifferentiated pleomorphic sarcoma (UPS; covering malignant fibrous histiocytoma) and synovial sarcoma.
- Bone sarcoma: Ewing's sarcoma (including extraskeletal), osteosarcoma, and chondrosarcoma.
Show all 17Show fewer
- Monotherapy arms:
- Sarcoma indications (including those listed for combination therapy arms) regardless of AXL gene amplification status.
- NSCLC regardless of AXL gene amplification status.
- Solid tumors (lymphomas participants are excluded) with known AXL gene amplification.
- Part 2:
- Combination therapy arms: Sarcoma indications and PAAD.
- Monotherapy arms: PAAD, NSCLC and solid tumors with AXL expression.
- Participants who are refractory to or intolerant to available standard therapy(ies) known to provide clinical benefit for their condition per Investigator judgment.
- Participants with measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.
- PAAD only: Royal Marsden Hospital Prognostic Score 0 - 1.
Who cannot join
- History of recent infection requiring intravenous (IV) antibiotics, IV antiviral, or IV antifungal treatment within 4 weeks of Cycle 1 Day 1 (C1D1).
- Symptomatic central nervous system (CNS) metastases or evidence of leptomeningeal disease (brain magnetic resonance imaging [MRI] or previously documented cerebrospinal fluid [CSF] cytology). Previously treated asymptomatic CNS metastases are permitted provided that the last treatment (systemic anticancer therapy and/or local radiotherapy) was completed ≥4 weeks prior to Day 1 except usage of low dose of steroids on a taper (i.e., up to 10 mg prednisone or equivalent on Day 1 and consecutive days is permissible if being tapered down). Participants with discrete dural metastases are eligible.
- Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or any serosal effusion that is either requiring drainage or associated with shortness of breath).
- Active diarrhea Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or a medical condition associated with chronic diarrhea (such as irritable bowel syndrome, inflammatory bowel disease).
- Use of any other experimental medication within 14 days prior to start of study drug (C1D1).
Trial locations and contacts
14 sites in 4 countries.
14 sites in 4 countries
United States6 sites
University of IOWA
Iowa City, Iowa, 52242
Vanderbilt University Medical Center (VUMC) - Ingram Cancer Center
Nashville, Tennessee, 37232
Sarah Cannon at University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 78229
Sarcoma Oncology Research Center
Santa Monica, California, 90403
Washington University School of Medicine
St Louis, Missouri, 63110
Stanford Cancer Center, Stanford Medicine at Stanford University
Stanford, California, 94305
France3 sites
Institut Bergonié
Bordeaux, Gironde, 33076
Institut Léon Bérard
Lyon, 69008
Centre Antoine Lacassagne
Nice, 06189
Spain3 sites
Hospital Universitario Vall d'Hebron
Barcelona, 08035
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
Hospital Universitario Madrid Sanchinarro
Madrid, 28050
United Kingdom2 sites
The Royal Marsden NHS Foundation Trust
London, England, SW3 6JJ
The Christie NHS Foundation Trust
Manchester, England, M20 4BX
About this study
Official title: A Phase 1b, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Mipasetamab Uzoptirine (ADCT-601) Monotherapy and in Combination With Other Anti-Cancer Therapies in Patients With Selected Advanced Solid Tumors
The primary objective of this study is to identify the recommended phase 2 dose (RP2D) and/or the maximum tolerated dose (MTD), and characterize the safety and tolerability of ADCT-601 monotherapy and in combination with gemcitabine.
- Conditions
- Advanced Solid Tumors
- Being tested
- ADCT-601, Gemcitabine
- Keywords
- Advanced solid tumors, Mipasetamab uzoptirine, ADCT-601, Sarcoma, Gemcitabine, AXL, Pancreatic cancer, NSCLC
- Medical subject headings
- Sarcoma, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADCT-601Drug
Also called Mipasetamab uzoptirine
Intravenous (IV) infusion
GemcitabineDrug
Intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose Escalation, ADCT-601 Combination Therapy | Experimental | In Part 1 (dose escalation), participants with selected sarcoma indications will receive escalating doses of ADCT-601 in combination with gemcitabine. Receives: Drug: ADCT-601; Drug: Gemcitabine |
| Part 1: Dose Escalation, ADCT-601 Monotherapy | Experimental | In Part 1 (dose escalation), participants with sarcoma indications (regardless of AXL gene amplification status), non-small-cell lung cancer (NSCLC) (regardless of AXL gene amplification status), and solid tumors with AXL gene amplification, will receive ADCT-601 monotherapy. Receives: Drug: ADCT-601 |
| Part 2: Dose Expansion, ADCT-601 Combination Therapy | Experimental | In Part 2 (dose expansion), participants with selected sarcoma indications will receive ADCT-601 in combination with gemcitabine.
Participants will be split into 3 cohorts:
Cohorts 5 and 6: Sarcoma indications.
Cohort 7: Pancreatic cancer. Receives: Drug: ADCT-601; Drug: Gemcitabine |
| Part 2: Dose Expansion, ADCT-601 Monotherapy | Experimental | In Part 2 (dose expansion), participants with a selected indication will receive ADCT-601 monotherapy.
Participants will be split into cohorts:
Cohort 1: Soft tissue sarcoma (STS).
Cohort 2: Pancreatic adenocarcinoma (PAAD).
Cohort 3: NSCLC.
Cohort 4: Solid tumors with known AXL expression. Receives: Drug: ADCT-601 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs)
Adverse events (AEs) and serious adverse events (SAEs) are defined as any untoward medical occurrence in participants whether or not considered related to the investigational medicinal product. Any clinically significant changes in vital signs, laboratory values, 12-lead electrocardiogram (ECG) and Eastern Cooperative Oncology Group (ECOG) performance status results will be recorded as AEs and SAEs.
Measured: Up to approximately 2 years
Number of Participants who Experience a Dose Limiting Toxicity (DLT)
Measured: Day 1 to Day 21
Number of Participants who Experience a Dose Interruption
Measured: Up to approximately 2 years
Number of Participants who Experience a Dose Reduction
Measured: Up to approximately 2 years
Secondary outcomes (16)
Overall Response Rate (ORR)
Measured: Up to approximately 2 years
Duration of Response (DOR)
Measured: Up to approximately 2 years
Progression-Free Survival (PFS)
Measured: Up to approximately 2 years
Overall Survival (OS)
Measured: Up to approximately 2 years
Serum Concentration of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199
Measured: Day 1 up to approximately 2 years
Maximum Concentration (Cmax) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum
Measured: Day 1 up to approximately 2 years
Time to Maximum Concentration (Tmax) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum
Measured: Day 1 up to approximately 2 years
Area Under the Concentration-time Curve from Time Zero to the Last Quantifiable Concentration (AUClast) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum
Measured: Day 1 up to approximately 2 years
Area Under the Concentration-time Curve from Time Zero to the End of the Dosing Interval (AUCtau) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum
Measured: Day 1 up to approximately 2 years
Area Under the Concentration-time Curve from Time Zero to Infinity (AUCinf) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum
Measured: Day 1 up to approximately 2 years
Apparent Terminal Elimination Half-life (T1/2) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum
Measured: Day 1 up to approximately 2 years
Apparent Clearance (CL) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum
Measured: Day 1 up to approximately 2 years
Apparent Steady-state Volume of Distribution (Vss) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum
Measured: Day 1 up to approximately 2 years
Accumulation Index (AI) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum
Measured: Day 1 up to approximately 2 years
Number of Participants With an Anti-drug Antibody (ADA) Response to ADCT-601
Measured: Day 1 up to approximately 2 years
Number of Participants With Anti-drug Antibody (ADA) Titers to ADCT-601
Measured: Day 1 up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start13 Jul 2022
- Primary completion17 Apr 2025
- Study completion17 Apr 2025
Why it stopped: Sponsor decided to halt further development of ADCT-601
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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- ADC Therapeutics S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389462
- Sponsor's protocol ID
- ADCT-601-102
- Other IDs
- 2021-005566-18
- Status last verified
- May 2025
- First submitted
- 20 May 2022
- Last updated
- 22 May 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 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Mipasetamab Uzoptirine (ADCT-601) Monotherapy and in Combination With Other Anti-Cancer Therapies in Patients With Selected Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05389462
- Acronym / sponsor ID
- ADCT-601-102
- Conditions
- Advanced Solid Tumors
- Keywords
- Advanced solid tumors, Mipasetamab uzoptirine, ADCT-601, Sarcoma, Gemcitabine, AXL, Pancreatic cancer, NSCLC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decided to halt further development of ADCT-601
- Enrolment
- 128 participants (actual)
- Lead sponsor
- ADC Therapeutics S.A.Industry (pharma, biotech, devices)
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- 17 Apr 2025 (actual)
- Study completion
- 17 Apr 2025 (actual)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to identify the recommended phase 2 dose (RP2D) and/or the maximum tolerated dose (MTD), and characterize the safety and tolerability of ADCT-601 monotherapy and in combination with gemcitabine.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose Escalation, ADCT-601 Combination Therapy | Experimental | Drug: ADCT-601, Drug: GemcitabineIn Part 1 (dose escalation), participants with selected sarcoma indications will receive escalating doses of ADCT-601 in combination with gemcitabine. |
| Part 1: Dose Escalation, ADCT-601 Monotherapy | Experimental | Drug: ADCT-601In Part 1 (dose escalation), participants with sarcoma indications (regardless of AXL gene amplification status), non-small-cell lung cancer (NSCLC) (regardless of AXL gene amplification status), and solid tumors with AXL gene amplification, will receive ADCT-601 monotherapy. |
| Part 2: Dose Expansion, ADCT-601 Combination Therapy | Experimental | Drug: ADCT-601, Drug: GemcitabineIn Part 2 (dose expansion), participants with selected sarcoma indications will receive ADCT-601 in combination with gemcitabine. Participants will be split into 3 cohorts: Cohorts 5 and 6: Sarcoma indications. Cohort 7: Pancreatic cancer. |
| Part 2: Dose Expansion, ADCT-601 Monotherapy | Experimental | Drug: ADCT-601In Part 2 (dose expansion), participants with a selected indication will receive ADCT-601 monotherapy. Participants will be split into cohorts: Cohort 1: Soft tissue sarcoma (STS). Cohort 2: Pancreatic adenocarcinoma (PAAD). Cohort 3: NSCLC. Cohort 4: Solid tumors with known AXL expression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Male or female participant aged 18 years or older.
- Pathologic diagnosis of solid tumor malignancy that is locally advanced or metastatic at time of screening:
- Participants who are refractory to or intolerant to available standard therapy(ies) known to provide clinical benefit for their condition per Investigator judgment.
- Participants with measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.
Key exclusion criteria (5 listed)
- History of recent infection requiring intravenous (IV) antibiotics, IV antiviral, or IV antifungal treatment within 4 weeks of Cycle 1 Day 1 (C1D1).
- Symptomatic central nervous system (CNS) metastases or evidence of leptomeningeal disease (brain magnetic resonance imaging [MRI] or previously documented cerebrospinal fluid [CSF] cytology). Previously treated asymptomatic CNS metastases are permitted provided that the last treatment (systemic anticancer therapy and/or local radiotherapy) was completed ≥4 weeks prior to Day 1 except usage of low dose of steroids on a taper (i.e., up to 10 mg prednisone or equivalent on Day 1 and consecutive days is permissible if being tapered down). Participants with discrete dural metastases are eligible.
- Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or any serosal effusion that is either requiring drainage or associated with shortness of breath).
- Active diarrhea Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or a medical condition associated with chronic diarrhea (such as irritable bowel syndrome, inflammatory bowel disease).
- Use of any other experimental medication within 14 days prior to start of study drug (C1D1).
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 |
|---|---|---|
| ADCT-601Also: Mipasetamab uzoptirineIntravenous (IV) infusion | Drug | Part 1: Dose Escalation, ADCT-601 Combination Therapy, Part 1: Dose Escalation, ADCT-601 Monotherapy, Part 2: Dose Expansion, ADCT-601 Combination Therapy, Part 2: Dose Expansion, ADCT-601 Monotherapy |
| GemcitabineIntravenous (IV) infusion | Drug | Part 1: Dose Escalation, ADCT-601 Combination Therapy, Part 2: Dose Expansion, ADCT-601 Combination Therapy |
Primary outcome
Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs)
Time frame: Up to approximately 2 years
Adverse events (AEs) and serious adverse events (SAEs) are defined as any untoward medical occurrence in participants whether or not considered related to the investigational medicinal product. Any clinically significant changes in vital signs, laboratory values, 12-lead electrocardiogram (ECG) and Eastern Cooperative Oncology Group (ECOG) performance status results will be recorded as AEs and SAEs.
Number of Participants who Experience a Dose Limiting Toxicity (DLT)
Time frame: Day 1 to Day 21
Number of Participants who Experience a Dose Interruption
Time frame: Up to approximately 2 years
Number of Participants who Experience a Dose Reduction
Time frame: Up to approximately 2 years
16 secondary outcomes
Overall Response Rate (ORR)
Time frame: Up to approximately 2 years
Duration of Response (DOR)
Time frame: Up to approximately 2 years
Progression-Free Survival (PFS)
Time frame: Up to approximately 2 years
Overall Survival (OS)
Time frame: Up to approximately 2 years
Serum Concentration of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199
Time frame: Day 1 up to approximately 2 years
Maximum Concentration (Cmax) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum
Time frame: Day 1 up to approximately 2 years
Time to Maximum Concentration (Tmax) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum
Time frame: Day 1 up to approximately 2 years
Area Under the Concentration-time Curve from Time Zero to the Last Quantifiable Concentration (AUClast) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum
Time frame: Day 1 up to approximately 2 years
Area Under the Concentration-time Curve from Time Zero to the End of the Dosing Interval (AUCtau) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum
Time frame: Day 1 up to approximately 2 years
Area Under the Concentration-time Curve from Time Zero to Infinity (AUCinf) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum
Time frame: Day 1 up to approximately 2 years
Apparent Terminal Elimination Half-life (T1/2) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum
Time frame: Day 1 up to approximately 2 years
Apparent Clearance (CL) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum
Time frame: Day 1 up to approximately 2 years
Apparent Steady-state Volume of Distribution (Vss) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum
Time frame: Day 1 up to approximately 2 years
Accumulation Index (AI) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum
Time frame: Day 1 up to approximately 2 years
Number of Participants With an Anti-drug Antibody (ADA) Response to ADCT-601
Time frame: Day 1 up to approximately 2 years
Number of Participants With Anti-drug Antibody (ADA) Titers to ADCT-601
Time frame: Day 1 up to approximately 2 years
Results and safety
The study was stopped early (reason given: Sponsor decided to halt further development of ADCT-601). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 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.
14 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ADCT-601 and Gemcitabine in people with Advanced Solid Tumors, run by ADC Therapeutics S.A. at 14 sites in 4 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 17 inclusion and 5 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 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, France, 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 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?
The study was stopped early (reason given: Sponsor decided to halt further development of ADCT-601). 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?
Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) (time frame: Up to approximately 2 years). 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 22 May 2025.