Metastatic Colorectal CancerPhase 2NCT06106308
Study of Onvansertib in Combination With FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab Versus FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab for First-Line Treatment of Metastatic Colorectal Cancer in Adult Participants With a KRAS or NRAS Mutation
A Phase 2 study testing Onvansertib, FOLFIRI and Bevacizumab in people with Metastatic Colorectal Cancer and CRC, run by Cardiff Oncology at 41 sites in United States.
Trial summary
The purpose of this study is to assess 2 different doses of onvansertib to select the lowest dose that is maximally effective, and to assess the safety, efficacy, pharmacokinetics, and pharmacodynamics of onvansertib in combination with FOLFIRI + bevacizumab or FOLFOX + bevacizumab in patients with KRAS or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer, CRC, KRAS/NRAS Mutation
- What is being tested?
- Onvansertib, FOLFIRI and Bevacizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 41 sitesUnited States
- Study dates
- 27 Feb 2024to Jan 2027
- Phase
- Phase 2
- 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 confirmed metastatic colorectal cancer.
- Documented KRAS or NRAS mutation.
- No previous systemic therapy in the metastatic setting.
- Participants must be willing to submit archival tissue or undergo fresh biopsy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Women of childbearing potential must use contraception or take measures to avoid pregnancy.
- Imaging computed tomography (CT) or magnetic resonance imaging (MRI) of chest/abdomen/pelvis and other scans as necessary to document all sites of disease performed within 28 days prior to the first dose of onvansertib.
- Must have acceptable organ function
Who cannot join
- Concomitant KRAS or NRAS and BRAF-V600 mutation or microsatellite instability high/deficient mismatch repair.
- Prior treatment with a VEGF inhibitor, including bevacizumab or biosimilars.
- Previous oxaliplatin treatment within 12 months prior to randomization, when arm open.
- Known dihydropyrimidine dehydrogenase (DPD) deficiency.
- Anticancer chemotherapy or biologic therapy administered within 28 days prior to the first dose of study drug.
- Untreated or symptomatic brain metastasis.
Show all 13Show fewer
- Gastrointestinal (GI) disorder(s) that would significantly impede the absorption of an oral agent.
- Unable or unwilling to swallow study drug.
- Uncontrolled intercurrent illness.
- Known hypersensitivity to fluoropyrimidine or leucovorin, irinotecan, or oxalipatin.
- Abnormal glucuronidation of bilirubin; known Gilbert's syndrome.
- Use of strong CYP3A4 or CYP2C19 inhibitors or strong CYP3A4 inducers.
- QTc >470
Trial locations and contacts
41 sites in 1 country.
41 sites in 1 country
United States41 sites
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
Pacific Cancer Medical Center
Anaheim, California, 92801
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911
Comprehensive Blood and Cancer Center - Bakersfield
Bakersfield, California, 93309
University of Virginia
Charlottesville, Virginia, 22908
Trihealth Kenwood
Cincinnati, Ohio, 45242
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Cleveland Clinic
Cleveland, Ohio, 44195
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46804
Orange Coast Memorial Medical Center
Fountain Valley, California, 92708
West Cancer Clinic
Germantown, Tennessee, 38138
Cancer & Hematology Centers of Western Michigan - Lemmen-Holton Cancer Pavilion
Grand Rapids, Michigan, 49503
Memorial Cancer Institute
Hollywood, Florida, 33021
Kaiser Permanente
Honolulu, Hawaii, 96819
Oncology Consultants, PA
Houston, Texas, 77024
MD Anderson Cancer Center
Houston, Texas, 77030
Mayo Clinic - Florida
Jacksonville, Florida, 32224
St. Bernards Medical Center
Jonesboro, Arkansas, 72401
Saint Luke's Hospital
Kansas City, Missouri, 64111
UC San Diego Moores Cancer Center
La Jolla, California, 92037
CCCN
Las Vegas, Nevada, 89119
Norris Comprehensive Cancer Center
Los Angeles, California, 90089
UCLA Department of Medicine-Hematology/Oncology
Los Angeles, California, 90095
Manhattan Hematology Oncology (MHO) Research Foundation, Inc.
New York, New York, 10016
Mayo Clinic - Arizona
Phoenix, Arizona, 85054
Oregon Health and Science University
Portland, Oregon, 97239
VCU Massey Cancer Center
Richmond, Virginia, 23298
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
Utah Cancer Specialists
Salt Lake City, Utah, 84124
Sharp Memorial Hospital
San Diego, California, 92123
Virginia Mason Medical Center
Seattle, Washington, 98101
Highlands Oncology Group
Springdale, Arkansas, 72762
Washington University School of Medicine Center for Advanced Medicine
St Louis, Missouri, 63110
Cleveland Clinic Martin Health
Stuart, Florida, 34994
Torrance Memorial Physician Network - Cancer Care and Infusion Center
Torrance, California, 90505
The University of Arizona Cancer Center
Tucson, Arizona, 85724
The University of Kansas Cancer Center - Westwood
Westwood, Kansas, 66205
PIH Health
Whittier, California, 90602
Cancer Center of Kansas
Wichita, Kansas, 67214
About this study
Official title: A Phase 2, Randomized, Open-label Study of Onvansertib in Combination With FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab Versus FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab for First-line Treatment of Metastatic Colorectal Cancer in Patients With a KRAS or NRAS Mutation
The purpose of this study is to assess 2 different doses of onvansertib to select the lowest dose that is maximally effective, and to assess the safety, efficacy, pharmacokinetics, and pharmacodynamics of onvansertib in combination with FOLFIRI + bevacizumab or FOLFOX + bevacizumab in patients with KRAS or NRAS-mutated metastatic colorectal cancer (CRC) in the first-line setting.
- Conditions
- Metastatic Colorectal Cancer, CRC, KRAS/NRAS Mutation
- Being tested
- Onvansertib, FOLFIRI, Bevacizumab, FOLFOX
- Keywords
- Metastatic Colorectal Cancer, KRAS Mutation, NRAS Mutation, CRC, First-Line
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnvansertibDrug
Oral capsule
FOLFIRIDrug
FOLFIRI (irinotecan + fluorouracil [5-FU] + leucovorin) as intravenous (IV) infusion
BevacizumabDrug
IV Infusion
FOLFOXDrug
FOLFOX (leucovorin + fluorouracil [5-FU] + oxaliplatin) as intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| Onvansertib 20mg + Standard of Care | Experimental | Participants will receive 20 mg of onvansertib on Days 1 to 5 and Days 15 to 19 of each 28-day treatment cycle + FOLFIRI/BEV on Day 1 and Day 15 of each 28-day treatment cycle. Receives: Drug: Onvansertib; Drug: FOLFIRI; Drug: Bevacizumab |
| Onvansertib 30 mg + Standard of Care (SOC) | Experimental | Participants will receive 30 mg of onvansertib + on Days 1 to 5 and Days 15 to 19 of each 28-day treatment cycle + FOLFIRI on Day 1 and Day 15 of each 28-day treatment cycle. Receives: Drug: Onvansertib; Drug: FOLFIRI; Drug: Bevacizumab |
| Standard of Care (SOC) | Active comparator | Participants will receive FOLFIRI/Bev on Day 1 and Day 15 of each 28-day treatment cycle. Receives: Drug: FOLFIRI; Drug: Bevacizumab |
| Onvansertib 20 mg + Standard of Care | Experimental | Participants will receive 20 mg of onvansertib on Days 1 to 5 and Days 15 to 19 of each 28-day treatment cycle + FOLFOX on Day 1 and Day 15 of each 28-day treatment cycle. Receives: Drug: Onvansertib; Drug: Bevacizumab; Drug: FOLFOX |
| Onvansertib 30 mg + Standard of Care | Experimental | Participants will receive 30 mg onvansertib on Days 1 to 5 and Days 15 to 19 of each 28-day treatment cycle + FOLFOX on Day 1 and Day 15 of each 28-day treatment cycle. Receives: Drug: Onvansertib; Drug: Bevacizumab; Drug: FOLFOX |
| Standard of Care | Active comparator | Participants will receive FOLFOX/Bev on Day 1 and Day 15 of each 28-day treatment cycle. Receives: Drug: Bevacizumab; Drug: FOLFOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
ORR defined as the proportion of participants who achieved a best overall Response (BOR) of CR or PR per RECIST Version 1.1 from randomization until disease progression, or death due to any cause, as determined by blinded independent central review.
Measured: Up to approximately 1 year
Secondary outcomes (11)
Progression Free Survival (PFS)
PFS defined as the time from the date of randomization to the earliest documented disease progression per RECIST version 1.1, or death due to any cause, as determined by blinded independent central review.
Measured: Up to approximately 1 year
Duration of Response (DOR)
DOR defined as the time from the date of first documentation of objective tumor response (CR or PR) to the earliest documented disease progression per RECIST version 1.1, or death due to any cause, as determined by blinded independent central review.
Measured: Up to approximately 1 year
Number of Participants with an Adverse Event (AE)
Type, incidence, causality and severity of AEs based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0. Clinically significant changes from baseline in vital signs, laboratory parameters, electrocardiograms (ECGs), weight, and Eastern Cooperative Oncology Group (ECOG) performance status will be recorded as AEs.
Measured: Up to approximately 1 year
Disease Control Rate (DCR)
DCR defined as CR plus PR plus stable disease (SD), as determined by independent central review.
Measured: Up to approximately 1 year
Overall Survival (OS)
OS defined as the time from drug administration to death due to any cause.
Measured: Up to approximately 1 year
Overall Response (OR)
Defined as CR or PR, PFS, DCR, DOR, and OS associated with a reduction in circulating tumor DNA (ctDNA) mutation allele frequency (MAF).
Measured: Up to approximately 1 year
Maximum Concentration (Cmax) of Onvansertib and metabolites in combination w/FOLFIRI and bevacizumab or FOLFOX and bevacizumab
Measured: Day 1 and Day 5 of Cycle 1, and Day 5 of Cycle 3 (cycle is 28 days)
Area Under the Plasma Concentration Curve (AUC) of Onvansertib and metabolites in combination w/FOLFIRI and bevacizumab or FOLFOX and bevacizumab
Measured: Day 1 and Day 5 of Cycle 1, and Day 5 of Cycle 3 (cycle is 28 days)
Trough Concentration (Ctrough) of Onvansertib and metabolites in combination w/FOLFIRI and bevacizumab or FOLFOX and bevacizumab
Measured: Day 1 and Day 5 of Cycle 1, and Day 5 of Cycle 3 (cycle is 28 days)
Efficacy: Exposure Response Evaluation of Onvansertib
Measured: Up to approximately 1 year
Safety: Exposure Response Evaluation of Onvansertib
Measured: Up to approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start27 Feb 2024
- Primary completionNov 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Colorectal CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiff Oncology
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06106308
- Sponsor's protocol ID
- CRDF-004
- Status last verified
- Jun 2026
- First submitted
- 24 Oct 2023
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ahn DH, Ridinger M, Cannon TL, Mendelsohn L, Starr JS, Hubbard JM, Kasi A, Barzi A, Samuelsz E, Karki A, Subramanian RA, Yemane D, Kim R, Wu CC, Croucher PJP, Smeal T, Kabbinavar FF, Lenz HJ. Onvansertib in Combination With Chemotherapy and Bevacizumab in Second-Line Treatment of KRAS-Mutant Metastatic Colorectal Cancer: A Single-Arm, Phase II Trial. J Clin Oncol. 2025 Mar;43(7):840-851. doi: 10.1200/JCO-24-01266. Epub 2024 Oct 30.
PubMed 39475591
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Open-label Study of Onvansertib in Combination With FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab Versus FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab for First-line Treatment of Metastatic Colorectal Cancer in Patients With a KRAS or NRAS Mutation
- ClinicalTrials.gov ID
- NCT06106308
- Acronym / sponsor ID
- CRDF-004
- Conditions
- Metastatic Colorectal Cancer, CRC, KRAS/NRAS Mutation
- Keywords
- Metastatic Colorectal Cancer, KRAS Mutation, NRAS Mutation, CRC, First-Line
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Cardiff OncologyIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 30 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.
The purpose of this study is to assess 2 different doses of onvansertib to select the lowest dose that is maximally effective, and to assess the safety, efficacy, pharmacokinetics, and pharmacodynamics of onvansertib in combination with FOLFIRI + bevacizumab or FOLFOX + bevacizumab in patients with KRAS or NRAS-mutated metastatic colorectal cancer (CRC) in the first-line setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Onvansertib 20mg + Standard of Care | Experimental | Drug: Onvansertib, Drug: FOLFIRI, Drug: BevacizumabParticipants will receive 20 mg of onvansertib on Days 1 to 5 and Days 15 to 19 of each 28-day treatment cycle + FOLFIRI/BEV on Day 1 and Day 15 of each 28-day treatment cycle. |
| Onvansertib 30 mg + Standard of Care (SOC) | Experimental | Drug: Onvansertib, Drug: FOLFIRI, Drug: BevacizumabParticipants will receive 30 mg of onvansertib + on Days 1 to 5 and Days 15 to 19 of each 28-day treatment cycle + FOLFIRI on Day 1 and Day 15 of each 28-day treatment cycle. |
| Standard of Care (SOC) | Active comparator | Drug: FOLFIRI, Drug: BevacizumabParticipants will receive FOLFIRI/Bev on Day 1 and Day 15 of each 28-day treatment cycle. |
| Onvansertib 20 mg + Standard of Care | Experimental | Drug: Onvansertib, Drug: Bevacizumab, Drug: FOLFOXParticipants will receive 20 mg of onvansertib on Days 1 to 5 and Days 15 to 19 of each 28-day treatment cycle + FOLFOX on Day 1 and Day 15 of each 28-day treatment cycle. |
| Onvansertib 30 mg + Standard of Care | Experimental | Drug: Onvansertib, Drug: Bevacizumab, Drug: FOLFOXParticipants will receive 30 mg onvansertib on Days 1 to 5 and Days 15 to 19 of each 28-day treatment cycle + FOLFOX on Day 1 and Day 15 of each 28-day treatment cycle. |
| Standard of Care | Active comparator | Drug: Bevacizumab, Drug: FOLFOXParticipants will receive FOLFOX/Bev on Day 1 and Day 15 of each 28-day treatment cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed metastatic colorectal cancer.
- Documented KRAS or NRAS mutation.
- No previous systemic therapy in the metastatic setting.
- Participants must be willing to submit archival tissue or undergo fresh biopsy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (13 listed)
- Concomitant KRAS or NRAS and BRAF-V600 mutation or microsatellite instability high/deficient mismatch repair.
- Prior treatment with a VEGF inhibitor, including bevacizumab or biosimilars.
- Previous oxaliplatin treatment within 12 months prior to randomization, when arm open.
- Known dihydropyrimidine dehydrogenase (DPD) deficiency.
- Anticancer chemotherapy or biologic therapy administered within 28 days prior to the first dose 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 |
|---|---|---|
| OnvansertibOral capsule | Drug | Onvansertib 20 mg + Standard of Care, Onvansertib 20mg + Standard of Care, Onvansertib 30 mg + Standard of Care, Onvansertib 30 mg + Standard of Care (SOC) |
| FOLFIRIFOLFIRI (irinotecan + fluorouracil [5-FU] + leucovorin) as intravenous (IV) infusion | Drug | Onvansertib 20mg + Standard of Care, Onvansertib 30 mg + Standard of Care (SOC), Standard of Care (SOC) |
| BevacizumabIV Infusion | Drug | Onvansertib 20 mg + Standard of Care, Onvansertib 20mg + Standard of Care, Onvansertib 30 mg + Standard of Care, Onvansertib 30 mg + Standard of Care (SOC), Standard of Care, Standard of Care (SOC) |
| FOLFOXFOLFOX (leucovorin + fluorouracil [5-FU] + oxaliplatin) as intravenous (IV) infusion | Drug | Onvansertib 20 mg + Standard of Care, Onvansertib 30 mg + Standard of Care, Standard of Care |
Primary outcome
Objective Response Rate (ORR)
Time frame: Up to approximately 1 year
ORR defined as the proportion of participants who achieved a best overall Response (BOR) of CR or PR per RECIST Version 1.1 from randomization until disease progression, or death due to any cause, as determined by blinded independent central review.
11 secondary outcomes
Progression Free Survival (PFS)
Time frame: Up to approximately 1 year
Duration of Response (DOR)
Time frame: Up to approximately 1 year
Number of Participants with an Adverse Event (AE)
Time frame: Up to approximately 1 year
Disease Control Rate (DCR)
Time frame: Up to approximately 1 year
Overall Survival (OS)
Time frame: Up to approximately 1 year
Overall Response (OR)
Time frame: Up to approximately 1 year
Maximum Concentration (Cmax) of Onvansertib and metabolites in combination w/FOLFIRI and bevacizumab or FOLFOX and bevacizumab
Time frame: Day 1 and Day 5 of Cycle 1, and Day 5 of Cycle 3 (cycle is 28 days)
Area Under the Plasma Concentration Curve (AUC) of Onvansertib and metabolites in combination w/FOLFIRI and bevacizumab or FOLFOX and bevacizumab
Time frame: Day 1 and Day 5 of Cycle 1, and Day 5 of Cycle 3 (cycle is 28 days)
Trough Concentration (Ctrough) of Onvansertib and metabolites in combination w/FOLFIRI and bevacizumab or FOLFOX and bevacizumab
Time frame: Day 1 and Day 5 of Cycle 1, and Day 5 of Cycle 3 (cycle is 28 days)
Efficacy: Exposure Response Evaluation of Onvansertib
Time frame: Up to approximately 1 year
Safety: Exposure Response Evaluation of Onvansertib
Time frame: Up to approximately 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 16 Jun 2026.
- Derived from this study: PubMed 39475591Ahn DH, Ridinger M, Cannon TL, Mendelsohn L, Starr JS, Hubbard JM, Kasi A, Barzi A, Samuelsz E, Karki A, Subramanian RA, Yemane D, Kim R, Wu CC, Croucher PJP, Smeal T, Kabbinavar FF, Lenz HJ. Onvansertib in Combination With Chemotherapy and Bevacizumab in Second-Line Treatment of KRAS-Mutant Metastatic Colorectal Cancer: A Single-Arm, Phase II Trial. J Clin Oncol. 2025 Mar;43(7):840-851. doi: 10.1200/JCO-24-01266. Epub 2024 Oct 30.
- 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.
41 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Onvansertib, FOLFIRI and Bevacizumab in people with Metastatic Colorectal Cancer and CRC, run by Cardiff Oncology at 41 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 8 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: under way, not looking for participants, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
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?
Objective Response Rate (ORR) (time frame: Up to approximately 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06106308, which also lists 1 linked publication.
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 16 Jun 2026.