Colorectal NeoplasmsPhase 1NCT06663319
A Study of JNJ-89402638 for Metastatic Colorectal and Gastric Cancers
A Phase 1 study testing JNJ-89402638, Bevacizumab and FOLFOX in people with Colorectal Neoplasms and Gastrointestinal Neoplasms, run by Janssen Research & Development, LLC at 12 sites in 3 countries.
Trial summary
The purpose of this study is to determine the putative recommended phase 2 dose(s) (RP2Ds) and best way to take (optimal route of administration) JNJ-89402638 and to determine the safety of JNJ-89402638 at the RP2D(s) in participants with metastatic colorectal cancer (mCRC) and metastatic gastric cancer (mGAC) and to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms, Gastrointestinal Neoplasms
- What is being tested?
- JNJ-89402638, Bevacizumab and FOLFOX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 15 Oct 2024to 19 Jul 2028
- 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
- For Part 1 (dose escalation), Part 2 (Arm A [JNJ-89402638 monotherapy]): Have histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma (CRC) progressing after 2 or more prior lines of standard therapy in the metastatic/unresectable setting; For Part 2 Arm B (JNJ-89402638 + bevacizumab or biosimilar): Have histologically or cytologically confirmed diagnosis of CRC progressing after 2 or more prior lines of standard therapy in the metastatic/unresectable setting; For Part 2 Arm C (JNJ-89402638 + FOLFOX/bevacizumab or biosimilar): Have histologically or cytologically confirmed diagnosis of microsatellite stable (MSS) or proficient mismatch repair (pMMR) CRC progressing after 1 or more prior lines of standard therapy in the metastatic/unresectable setting. Participants must have previously received a fluoropyrimidine and irinotecan doublet (such as FOLFIRI); For Part 2 Arm D (JNJ-89402638 + FOLFIRI/bevacizumab or biosimilar): Have histologically or cytologically confirmed diagnosis of MSS or pMMR CRC progressing after 1 prior line of standard therapy in the metastatic/unresectable setting. Must not have received irinotecan previously for metastatic disease; For Part 2 Arm E (JNJ-89402638 monotherapy in mGAC): Have histologically or cytologically confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction adenocarcinoma progressing after 1 or more prior lines of standard therapy in the metastatic/unresectable setting
- Have evaluable or measurable disease per response evaluation criteria in solid tumors (RECIST) version 1.1
- Part 1: Must have either measurable or evaluable disease
- Part 2: Must have at least 1 measurable lesion
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Have an estimated or measured glomerular filtration rate (GFR) greater than or equal to (>=) 30 milliliter per minute (mL/min) based on modification of diet in renal disease (MDRD) 4-variable formula
Who cannot join
- Active (new or progressive) brain metastases, leptomeningeal disease, or untreated spinal cord compression
- Toxicity from prior anticancer therapy that has not resolved to Grade less than or equal to (<=)1 (except alopecia, vitiligo, Grade <= 2 peripheral neuropathy, or endocrinopathies that are stable on hormone replacement). For Part 2 Arm C: Grade 2 or higher peripheral neuropathy is considered exclusionary
- Has a prior or concurrent second malignancy (other than the disease under study) unless natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment
- Received glucocorticoids (doses >10 mg/day prednisone or equivalent) within 7 days prior to the first dose of study drug
- Received or plans to receive any live, attenuated vaccine within 4 weeks before the first dose of study treatment or within 4 weeks after the last dose of study treatment
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 States6 sites, 6 recruiting
- Recruiting
University of Colorado Denver Anschultz Medical Campus
Aurora, Colorado, 80045
- Recruiting
Start Midwest
Grand Rapids, Michigan, 49546
- Recruiting
Community Health Network
Indianapolis, Indiana, 46256
- Recruiting
Florida Cancer Specialists
Sarasota, Florida, 34232
- Recruiting
Swedish Cancer Institute
Seattle, Washington, 98104
- Recruiting
University of Arizona Cancer Center
Tucson, Arizona, 85719
Spain4 sites, 4 recruiting
- Recruiting
Hosp Univ Vall D Hebron
Barcelona, 08035
- Recruiting
Hosp Univ Fund Jimenez Diaz
Madrid, 28040
- Recruiting
Hosp. Univ. 12 de Octubre
Madrid, 28041
- Recruiting
Hosp Univ Hm Sanchinarro
Madrid, 28050
South Korea2 sites, 2 recruiting
- Recruiting
Severance Hospital Yonsei University Health System
Seoul, 03722
- Recruiting
Asan Medical Center
Seoul, 05505
About this study
Official title: A Phase 1 Study of JNJ-89402638 for Unresectable Metastatic Colorectal Cancer and Other Gastrointestinal Malignancies
The purpose of this study is to determine the putative recommended phase 2 dose(s) (RP2Ds) and best way to take (optimal route of administration) JNJ-89402638 and to determine the safety of JNJ-89402638 at the RP2D(s) in participants with metastatic colorectal cancer (mCRC) and metastatic gastric cancer (mGAC) and to determine the safety and tolerability of JNJ-89402638 in combination with bevacizumab or biosimilar with or without chemotherapy in participants with mCRC.
- Conditions
- Colorectal Neoplasms, Gastrointestinal Neoplasms
- Being tested
- JNJ-89402638, Bevacizumab, FOLFOX, FOLFIRI
- Medical subject headings
- Colorectal Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-89402638Drug
JNJ-89402638 will be administered.
BevacizumabDrug
Bevacizumab or biosimilar will be administered.
FOLFOXDrug
Chemotherapy agent FOLFOX will be administered.
FOLFIRIDrug
Chemotherapy agent FOLFIRI will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 (Dose Expansion) | Experimental | Participants with unresectable metastatic colorectal adenocarcinoma (mCRC) will receive JNJ-89402638 in Part 1 (Dose escalation) of the study and the dose levels will be escalated sequentially until the recommended Phase 2 Dose(s) (RP2D) and optimal route(s) of administration for JNJ-89402638 monotherapy have been identified. Receives: Drug: JNJ-89402638 |
| Part 2 (Dose Expansion): Arm A | Experimental | Participants with mCRC will receive JNJ-89402638 at the RP2D(s) and route as determined in Part 1 as a monotherapy. Receives: Drug: JNJ-89402638 |
| Part 2 (Dose Expansion): Arm B | Experimental | Participants with mCRC will receive JNJ-89402638 at the RP2D(s) determined in Part 1 along with bevacizumab or biosimilar. Receives: Drug: JNJ-89402638; Drug: Bevacizumab |
| Part 2 (Dose Expansion): Arm C | Experimental | Participants with mCRC will receive JNJ-89402638 at the RP2D(s) determined in Part 1 along with bevacizumab or biosimilar and FOLFOX. Receives: Drug: JNJ-89402638; Drug: Bevacizumab; Drug: FOLFOX |
| Part 2 (Dose Expansion): Arm D | Experimental | Participants with mCRC will receive JNJ-89402638 at the RP2D(s) determined in Part 1 in combination with bevacizumab or biosimilar and FOLFIRI. Receives: Drug: JNJ-89402638; Drug: Bevacizumab; Drug: FOLFIRI |
| Part 2 (Dose Expansion): Arm E | Experimental | Participants with metastatic gastric adenocarcinoma (mGAC) will receive JNJ-89402638 at the RP2D(s) and route as determined in Part 1. Receives: Drug: JNJ-89402638 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) will be graded per American Society for Transplantation and Cellular Therapy (ASTCT) consensus.
Measured: From Baseline up to approximately 24 months
Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)
The DLTs are specific adverse events including high grade hematologic or non-hematologic toxicities.
Measured: From Baseline up to 28 days
Secondary outcomes (10)
Part 1 and Part 2: Serum Concentration for JNJ-89402638
Serum Concentration for JNJ-89402638 will be reported.
Measured: Up to approximately 24 months
Part 1 and Part 2: Maximum Serum Concentration (Cmax) of JNJ-89402638
Cmax of JNJ-89402638 will be reported.
Measured: Up to approximately 24 months
Part 1 and Part 2: Minimum Serum Concentration (Cmin) of JNJ-89402638
Cmin of JNJ-89402638 will be reported.
Measured: Up to approximately 24 months
Part 1 and Part 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-89402638
Tmax of JNJ-89402638 will be reported.
Measured: Up to approximately 24 months
Part 1 and Part 2: Area Under the Serum Concentration-time Curve (AUC) of JNJ-89402638
AUC of JNJ-89402638 will be reported.
Measured: Up to approximately 24 months
Part 1 and Part 2: Number of Participants with Presence of Anti-JNJ-89402638 Antibodies
Participants with anti-JNJ-89402638 antibodies will be reported.
Measured: Up to approximately 24 months
Part 1 and Part 2: Overall Response (OR)
Overall response is best response of complete response (CR) or partial response (PR), assessed according to response evaluation criteria in solid tumors (RECIST) version 1.1.
Measured: Up to approximately 24 months
Part 1 and Part 2: Complete Response (CR)
Complete response is defined as a best response of CR assessed according to RECIST version 1.1.
Measured: Up to approximately 24 months
Part 1 and Part 2: Time to Response (TTR)
TTR is defined for participants who achieved an OR from the time of the first dose of study treatment to the first response of PR or better as assessed according to RECIST version 1.1.
Measured: Up to approximately 24 months
Part 1 and Part 2: Duration of Response (DOR)
DOR is defined for participants who achieved an OR in the time between the date of initial documentation of first response of PR or better to the date of first documented evidence of progressive disease or death due to any cause, whichever occurs first, as assessed according to RECIST version 1.1
Measured: Up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start15 Oct 2024
- Primary completion25 Feb 2028 (estimated)
- Study completion19 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- 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
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06663319
- Sponsor's protocol ID
- 89402638GIC1001
- Other IDs
- 2024-516526-66-00
- Status last verified
- Nov 2026
- First submitted
- 28 Oct 2024
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of JNJ-89402638 for Unresectable Metastatic Colorectal Cancer and Other Gastrointestinal Malignancies
- ClinicalTrials.gov ID
- NCT06663319
- Acronym / sponsor ID
- 89402638GIC1001
- Conditions
- Colorectal Neoplasms, Gastrointestinal Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 25 Feb 2028 (estimated)
- Study completion
- 19 Jul 2028 (estimated)
- First posted
- 29 Oct 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 purpose of this study is to determine the putative recommended phase 2 dose(s) (RP2Ds) and best way to take (optimal route of administration) JNJ-89402638 and to determine the safety of JNJ-89402638 at the RP2D(s) in participants with metastatic colorectal cancer (mCRC) and metastatic gastric cancer (mGAC) and to determine the safety and tolerability of JNJ-89402638 in combination with bevacizumab or biosimilar with or without chemotherapy in participants with mCRC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part 1 (Dose Expansion) | Experimental | Drug: JNJ-89402638Participants with unresectable metastatic colorectal adenocarcinoma (mCRC) will receive JNJ-89402638 in Part 1 (Dose escalation) of the study and the dose levels will be escalated sequentially until the recommended Phase 2 Dose(s) (RP2D) and optimal route(s) of administration for JNJ-89402638 monotherapy have been identified. |
| Part 2 (Dose Expansion): Arm A | Experimental | Drug: JNJ-89402638Participants with mCRC will receive JNJ-89402638 at the RP2D(s) and route as determined in Part 1 as a monotherapy. |
| Part 2 (Dose Expansion): Arm B | Experimental | Drug: JNJ-89402638, Drug: BevacizumabParticipants with mCRC will receive JNJ-89402638 at the RP2D(s) determined in Part 1 along with bevacizumab or biosimilar. |
| Part 2 (Dose Expansion): Arm C | Experimental | Drug: JNJ-89402638, Drug: Bevacizumab, Drug: FOLFOXParticipants with mCRC will receive JNJ-89402638 at the RP2D(s) determined in Part 1 along with bevacizumab or biosimilar and FOLFOX. |
| Part 2 (Dose Expansion): Arm D | Experimental | Drug: JNJ-89402638, Drug: Bevacizumab, Drug: FOLFIRIParticipants with mCRC will receive JNJ-89402638 at the RP2D(s) determined in Part 1 in combination with bevacizumab or biosimilar and FOLFIRI. |
| Part 2 (Dose Expansion): Arm E | Experimental | Drug: JNJ-89402638Participants with metastatic gastric adenocarcinoma (mGAC) will receive JNJ-89402638 at the RP2D(s) and route as determined in Part 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- For Part 1 (dose escalation), Part 2 (Arm A [JNJ-89402638 monotherapy]): Have histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma (CRC) progressing after 2 or more prior lines of standard therapy in the metastatic/unresectable setting; For Part 2 Arm B (JNJ-89402638 + bevacizumab or biosimilar): Have histologically or cytologically confirmed diagnosis of CRC progressing after 2 or more prior lines of standard therapy in the metastatic/unresectable setting; For Part 2 Arm C (JNJ-89402638 + FOLFOX/bevacizumab or biosimilar): Have histologically or cytologically confirmed diagnosis of microsatellite stable (MSS) or proficient mismatch repair (pMMR) CRC progressing after 1 or more prior lines of standard therapy in the metastatic/unresectable setting. Participants must have previously received a fluoropyrimidine and irinotecan doublet (such as FOLFIRI); For Part 2 Arm D (JNJ-89402638 + FOLFIRI/bevacizumab or biosimilar): Have histologically or cytologically confirmed diagnosis of MSS or pMMR CRC progressing after 1 prior line of standard therapy in the metastatic/unresectable setting. Must not have received irinotecan previously for metastatic disease; For Part 2 Arm E (JNJ-89402638 monotherapy in mGAC): Have histologically or cytologically confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction adenocarcinoma progressing after 1 or more prior lines of standard therapy in the metastatic/unresectable setting
- Have evaluable or measurable disease per response evaluation criteria in solid tumors (RECIST) version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Have an estimated or measured glomerular filtration rate (GFR) greater than or equal to (>=) 30 milliliter per minute (mL/min) based on modification of diet in renal disease (MDRD) 4-variable formula
Key exclusion criteria (5 listed)
- Active (new or progressive) brain metastases, leptomeningeal disease, or untreated spinal cord compression
- Toxicity from prior anticancer therapy that has not resolved to Grade less than or equal to (<=)1 (except alopecia, vitiligo, Grade <= 2 peripheral neuropathy, or endocrinopathies that are stable on hormone replacement). For Part 2 Arm C: Grade 2 or higher peripheral neuropathy is considered exclusionary
- Has a prior or concurrent second malignancy (other than the disease under study) unless natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment
- Received glucocorticoids (doses >10 mg/day prednisone or equivalent) within 7 days prior to the first dose of study drug
- Received or plans to receive any live, attenuated vaccine within 4 weeks before the first dose of study treatment or within 4 weeks after the last dose of study treatment
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 |
|---|---|---|
| JNJ-89402638JNJ-89402638 will be administered. | Drug | Part 1 (Dose Expansion), Part 2 (Dose Expansion): Arm A, Part 2 (Dose Expansion): Arm B, Part 2 (Dose Expansion): Arm C, Part 2 (Dose Expansion): Arm D, Part 2 (Dose Expansion): Arm E |
| BevacizumabBevacizumab or biosimilar will be administered. | Drug | Part 2 (Dose Expansion): Arm B, Part 2 (Dose Expansion): Arm C, Part 2 (Dose Expansion): Arm D |
| FOLFOXChemotherapy agent FOLFOX will be administered. | Drug | Part 2 (Dose Expansion): Arm C |
| FOLFIRIChemotherapy agent FOLFIRI will be administered. | Drug | Part 2 (Dose Expansion): Arm D |
Primary outcome
Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity
Time frame: From Baseline up to approximately 24 months
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) will be graded per American Society for Transplantation and Cellular Therapy (ASTCT) consensus.
Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)
Time frame: From Baseline up to 28 days
The DLTs are specific adverse events including high grade hematologic or non-hematologic toxicities.
10 secondary outcomes
Part 1 and Part 2: Serum Concentration for JNJ-89402638
Time frame: Up to approximately 24 months
Part 1 and Part 2: Maximum Serum Concentration (Cmax) of JNJ-89402638
Time frame: Up to approximately 24 months
Part 1 and Part 2: Minimum Serum Concentration (Cmin) of JNJ-89402638
Time frame: Up to approximately 24 months
Part 1 and Part 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-89402638
Time frame: Up to approximately 24 months
Part 1 and Part 2: Area Under the Serum Concentration-time Curve (AUC) of JNJ-89402638
Time frame: Up to approximately 24 months
Part 1 and Part 2: Number of Participants with Presence of Anti-JNJ-89402638 Antibodies
Time frame: Up to approximately 24 months
Part 1 and Part 2: Overall Response (OR)
Time frame: Up to approximately 24 months
Part 1 and Part 2: Complete Response (CR)
Time frame: Up to approximately 24 months
Part 1 and Part 2: Time to Response (TTR)
Time frame: Up to approximately 24 months
Part 1 and Part 2: Duration of Response (DOR)
Time frame: Up to approximately 24 months
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 3 Nov 2026.
- Individual participant dataSharing planned: Yes. The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
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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.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
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 JNJ-89402638, Bevacizumab and FOLFOX in people with Colorectal Neoplasms and Gastrointestinal Neoplasms, run by Janssen Research & Development, LLC 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 6 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: looking for participants now, as of the sponsor's last update on 3 Nov 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, Spain, 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 Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity (time frame: From Baseline up to approximately 24 months). The study lists 2 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 3 Nov 2026.