Stage IV Colorectal Cancer Positive for BRAF V600E MutationPhase 2NCT05576896

Hydroxychloroquine in Combination With Encorafenib and Cetuximab or Panitumumab in the Treatment of Metastatic BRAF-mutated Colorectal Cancer Refractory

A Phase 2 study testing Hydroxychloroquine in Combination With Encorafenib and Cetuximab or Panitumumab in people with Stage IV Colorectal Cancer Positive for BRAF V600E Mutation and Colorectal Cancer, run by Northwestern University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Stage IV Colorectal Cancer Positive for BRAF V600E Mutation, Colorectal Cancer, Colorectal Cancer Stage IV
What is being tested?: Hydroxychloroquine in Combination With Encorafenib and Cetuximab or Panitumumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 1 siteUnited States
Study dates: 10 Oct 2022to 20 Apr 2026
Phase: Phase 2
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

3.1.1 Patients must have histologically confirmed stage IV colorectal cancer positive for BRAF V600E mutation and on at least 1 prior line of systemic therapy and have not had any previous BRAF inhibitor therapy Patients must have measurable disease as defined by RECIST 1.1 See Section 7 for the evaluation of measurable disease. Baseline imaging scan will be used.
3.1.2 Patients must have discontinued prior chemotherapy or targeted therapy at least 14 days prior to D1 of starting study treatment (E+C). Note: patients are allowed to start standard of care treatment with Encorafenib and Cetuximab/panitumumab (prior to registration for up to 14 days).
3.1.3 Patients must be at least 18 years of age.
3.1.4 Patients must exhibit an ECOG performance status of 0 or 1.[Refer Appendix 1]
3.1.5 Patients must have adequate organ and bone marrow function as defined below. If laboratory values are outside these thresholds at screening, repeat labs can be done within a 14 day window. If lab values meet criteria at screening as delineated below, they do not need to be repeated: Leukocytes (WBC) ≥ 3,000/mcL, Absolute neutrophil count (ANC) ≥ 1,500/mcL, Hemoglobin (Hgb) ≥ 9 g/dL, Platelets (PLT) ≥ 100,000/mcL, Total bilirubin ≤ 1.5 x Institutional upper limit of normal (ULN), AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional ULN, or < 5x ULN in presence of liver metastases, Creatinine OR 1.5x ULN OR, Glomerular filtration rate (GFR) > 50 mL/min/1.73 m2
3.1.6 For patients with a known history of Human immunodeficiency virus (HIV), infected patients on effective anti-retroviral therapy must have an undetectable viral load.

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3.1.7 For patients with a known history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
3.1.8 Patients with a known history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
3.1.9 Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.
3.1.10 Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen.
3.1.11 Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better. Note: Patients with clinically significant cardiac disease, including New York Heart Association Class III or IV heart failure are not eligible. Refer Appendix 3
3.1.12 Females of child-bearing potential (FOCBP) are required to have a negative urine or serum pregnancy test within 7 days prior to commencement of dosing .Note: The test will have to be repeated if Cycle 1 Day1 is more than 3 days from registration.
3.1.13 The effects of Encorafenib and Cetuximab on the developing human fetus are unknown. For this reason and because Encorafenib, Cettuximab [Class C] agents as well as other therapeutic agents used in this trial may be teratogenic, females of child-bearing potential (FOCBP) and men must agree to use adequate contraception ( only effective non-hormonal methods of contraception are allowed e.g. barrier method; abstinence [Refer Appendix 4]) from time of informed consent (atleast 14 days prior to C1D1), for the duration of study participation, and for 4 months following completion of therapy. Should a female patient become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception from time of informed consent, for the duration of study participation, and 4 months after completion of administration. NOTE: At the discretion of the investigator, acceptable methods of contraception may include total abstinence in cases where the lifestyle of the patient ensures compliance. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception.) NOTE: Hormonal-based methods (e.g., oral contraceptives) are NOT permitted as contraception Since encorafenib can increase the serum concentration of oral contraceptive pills. Note: A FOCBP is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: • Has not undergone a hysterectomy or bilateral oophorectomy • Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for > 12 months).
3.1.14 Patients taking any type and number of prior anticancer therapies. Exception: BRAF or MEK inhibitors.
3.1.15 All prior anti-cancer treatment-related toxicities (except alopecia ,neuropathy and laboratory values as listed in Eligibility Criteria 3.1.6) must be Grade 1 or less according to the Common Terminology Criteria for Adverse Events version 5 (CTCAE version5) at the time of starting treatment (C1D1). [Refer Appendix 5] Note: If patient is receiving the 14 days of SOC treatment and has a toxicity attributed to that they would be permitted to register if the toxicity is clearly attributed to standard of care treatment and corresponding documentation is provided.
3.1.16 If patient received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
3.1.17 Patients should have a QTc interval of ≤480 ms on the EKG Note: A single 12-lead EKG is acceptable.
3.1.18 Patients must be able to swallow and retain oral medication and must not have any clinically significant gastrointestinal abnormalities (e.g., ulcerative diseases, uncontrolled vomiting, malabsorption syndrome, stomach resection, small bowel resection with decreased intestinal absorption) that may alter absorption.
3.1.19 Patients must have the ability to understand and the willingness to sign a written informed consent document.

Who cannot join

3.2.1 Patients who have had chemotherapy or radiotherapy ≤ 14 days prior to planned treatment start date. Note: patients are allowed to start standard of care treatment with Encorafenib and Cetuximab (prior to registration for up to 14 days).
3.2.2 Patients who are receiving any other investigational agents for at least 28 days before the first dose of study treatment i.e. C1D1 (which is start of E+C)
3.2.3 Patients receiving treatment with any of the following are not eligible: • Cyclical chemotherapy within a period of time that was shorter than the cycle length for that treatment prior to C1D1(E+C treatment) • Biologic therapy except bevacizumab or aflibercept, continuous or intermittent small molecule therapeutics, within a period of time that is < 5 half-lives or < 28 days prior to starting study treatment • Bevacizumab or aflibercept therapy < 21 days prior to starting study treatment • Radiation therapy including > 30% of the bone marrow. Note: Palliative radiation is allowed at the time of enrollment
3.2.4 Patients with leptomeningeal disease or metastases causing spinal cord compression that are symptomatic or untreated or not stable for ≥ 90 days (must be documented by imaging) or requiring corticosteroids. Subjects on a stable dose of corticosteroids > 28 days of no more than prednisone 10 mg daily or the equivalent, or who have been off of corticosteroids for at least 7 days before C1D1 (E+C), can be enrolled with approval of the medical monitor.
3.2.5 Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to hydroxychloroquine, encorafenib, or cetuximab.
3.2.6 Patients using any medications that are strong inhibitors or inducers of cytochrome P450 (CYP) 3A4/5 < 7 days prior to the start of study treatment. [Refer Appendix 6] Note: Grapefruit/ grapefruit juice and Seville oranges and starfruit are to be avoided during treatment.

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3.2.7 Patients with known history of acute or chronic pancreatitis.
3.2.8 Patients with history or current evidence of severe eye disease ( e.g. Retinal Vein Occlusion (RVO) or current risk factors for RVO including uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes)
3.2.9 Patients with history of thromboembolic or cerebrovascular events ≤ 90 days prior to C1D1 (start of E+C treatment), including transient ischemic attacks, cerebrovascular accidents, deep vein thrombosis or pulmonary emboli.
3.2.10 Concurrent neuromuscular disorder that is associated with the potential of elevated Creatine Kinase (CK) (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy).
3.2.11 Patients with known history of Gilbert's syndrome or is known to have any of the following genotypes: UGT1A1*6/*6, UGT1A1*28/*28, or UGT1A1*6/*28.
3.2.12 Patients with known psoriasis or porphyria.
3.2.13 Patients who have an uncontrolled intercurrent illness.
3.2.14 Female patients who are pregnant or nursing.
3.2.15 Patients with psychiatric illness/social situations that would limit compliance with study requirements.

Trial locations and contacts

1 site in 1 country.

United States1 site

Northwestern University
Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: A Single-Arm, Phase II Study of Autophagy Modulation Using Hydroxychloroquine in Combination With Encorafenib and Cetuximab or Panitumumab in Metastatic BRAF-mutated Colorectal Cancer Refractory to Standard Therapies

This is a Phase II, open label, single-arm trial study of adding hydroxychloroquine to encorafenib and cetuximab in patients with metastatic BRAF V600E colon cancer with progression on at least 1 prior line of therapy. We hypothesize that autophagy is a major mechanism of resistance to BRAF inhibition in stage IV BRAF V600E colorectal cancer, and that the addition of hydroxychloroquine to standard encorafenib and cetuximab therapy will help overcome this resistance.

Read the detailed description

Primary Objective -Determine the Objective Response Rate (ORR) of encorafenib, cetuximab or panitumumab, and hydroxychloroquine in patients with stage IV BRAF V600E mutated colorectal cancer.

Secondary Objectives

-Determine progression-free survival (PFS) of patients treated with encorafenib, cetuximab or panitumumab, and hydroxychloroquine.

Note: progression is defined as either radiological progression (with CT scan) OR clinical progression, which will be defined as 'clinical deterioration associated with rising CEA biomarker' (laboratory date of collection of sample to be noted).

Determine overall survival (OS) by RECIST v1.1 criteria of patients treated with encorafenib, cetuximab or panitumumab, and hydroxychloroquine.
Determine 'Duration of Response' (DoR) of patients treated with encorafenib, cetuximab or panitumumab, and hydroxychloroquine.
Determine 'Duration of Stable Disease'(DoSD) of patients treated with encorafenib, cetuximab or panitumumab, and hydroxychloroquine.
Estimate rates of drug-related toxicities when patients are treated with encorafenib, cetuximab or panitumumab, and hydroxychloroquine.

OUTLINE:

Prior to starting therapy, patients will have a pretreatment cross-sectional scan. Patients will then begin with encorafenib 300 mg daily starting with Cycle 1 day 1; then patients will receive IV cetuximab weekly, with 400 mg/m2 on C1D1 as a loading dose and 250 mg/m2 on all other days.

Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months (+/- 1 month) for the next 18 months.

Conditions: Stage IV Colorectal Cancer Positive for BRAF V600E Mutation, Colorectal Cancer, Colorectal Cancer Stage IV
Being tested: Hydroxychloroquine in Combination With Encorafenib and Cetuximab or Panitumumab
Medical subject headings: Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hydroxychloroquine in Combination With Encorafenib and Cetuximab or PanitumumabDrug
Prior to starting therapy, patients will have a pretreatment cross-sectional scan. Patients will then begin with encorafenib 300 mg daily starting with Cycle 1 day 1; then patients will receive IV cetuximab weekly, with 400 mg/m2 on C1D1 as a loading dose and 250 mg/m2 on all other days.
If desired for patient or physician convenience, q 2 week dosing of cetuximab (at dose of 500 mg/m2) or using the alternate agent panitumumab, also every 2 weeks at a dose of 6 mg/kg IV, can be allowed.
The first 14 days of cycle 1 will represent a priming phase, with hydroxychloroquine 400 mg q 12 hour added on C1D15 and continued.
Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Study groups in NCT05576896
Study group	Role	What they receive
Treatment (Hydroxychloroquine)	Experimental	Not described Receives: Drug: Hydroxychloroquine in Combination With Encorafenib and Cetuximab or Panitumumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Objective Response Rate (ORR)
To determine the ORR by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 criteria for the combination of encorafenib, cetuximab or panitumumab, and hydroxychloroquine. This will be assessed based on RECIST1.1 criteria by cross-sectional imaging done every 2 cycles.
Measured: Within 30 days (+/- 7 days) of coming off treatment

Secondary outcomes (5)

Progression-Free Survival (PFS)
To determine PFS by RECIST v1.1 criteria, with encorafenib, cetuximab or panitumumab, and hydroxychloroquine. Progression is defined as either radiological progression (with CT scan) OR clinical progression.
Measured: Up to 18 months after end of treatment
Overall Survival (OS)
Determine overall survival (OS) by using RECIST v1.1 criteria. Overall survival time is defined as the time that elapses between C1D1 (start of E+C treatment) and the date of death from any cause.
Measured: Up to 18 months after end of treatment
Duration of Response (DoR)
The evaluation of DoR of patients will be calculated as the time elapsed from the day when 'complete response (CR)' or 'partial response (PR)' is first observed.
Confirmation of response for CR or PR will be conducted via imaging.
Measured: Up to 18 months after end of treatment
Duration of Stable Disease (DoSD)
Duration of stable disease will be calculated as the time elapsed from the day when "stable disease" is first observed until the earlier of the day of first documented disease progression (clinical OR radiological) using imaging.
Measured: Up to 18 months after end of treatment
Adverse Events
To determine safety and tolerability of encorafenib, cetuximab or panitumumab, and hydroxychloroquine as determined by NCI CTCAE v 5.
Measured: Up to 18 months after end of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Oct 202220 Apr 2026

First posted13 Oct 2022
Study start10 Oct 2022
Primary completion24 Oct 2025
Study completion20 Apr 2026

Why it stopped: The study was closed due to accrual.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Stage IV Colorectal Cancer Positive for BRAF V600E MutationStudies of the same condition, open and under way.
More trials run by Northwestern UniversityThe 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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05576896
Sponsor's protocol ID: NU 22I05
Other IDs: Northwestern University, IRB#, P30CA060553, NCI-2022-08532
Status last verified: Jun 2026
First submitted: 10 Oct 2022
Last updated: 12 Jun 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Arm, Phase II Study of Autophagy Modulation Using Hydroxychloroquine in Combination With Encorafenib and Cetuximab or Panitumumab in Metastatic BRAF-mutated Colorectal Cancer Refractory to Standard Therapies
ClinicalTrials.gov ID: NCT05576896
Acronym / sponsor ID: NU 22I05
Conditions: Stage IV Colorectal Cancer Positive for BRAF V600E Mutation, Colorectal Cancer, Colorectal Cancer Stage IV
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was closed due to accrual.
Enrolment: 7 participants (actual)
Lead sponsor: Northwestern UniversityUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 10 Oct 2022 (actual)
Primary completion: 24 Oct 2025 (actual)
Study completion: 20 Apr 2026 (actual)
First posted: 13 Oct 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.

Detailed description

Primary Objective -Determine the Objective Response Rate (ORR) of encorafenib, cetuximab or panitumumab, and hydroxychloroquine in patients with stage IV BRAF V600E mutated colorectal cancer.

Secondary Objectives

-Determine progression-free survival (PFS) of patients treated with encorafenib, cetuximab or panitumumab, and hydroxychloroquine.

Determine overall survival (OS) by RECIST v1.1 criteria of patients treated with encorafenib, cetuximab or panitumumab, and hydroxychloroquine.
Determine 'Duration of Response' (DoR) of patients treated with encorafenib, cetuximab or panitumumab, and hydroxychloroquine.
Determine 'Duration of Stable Disease'(DoSD) of patients treated with encorafenib, cetuximab or panitumumab, and hydroxychloroquine.
Estimate rates of drug-related toxicities when patients are treated with encorafenib, cetuximab or panitumumab, and hydroxychloroquine.

OUTLINE:

Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months (+/- 1 month) for the next 18 months.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment (Hydroxychloroquine)	Experimental	Drug: Hydroxychloroquine in Combination With Encorafenib and Cetuximab or Panitumumab

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (19 listed)

3.1.1 Patients must have histologically confirmed stage IV colorectal cancer positive for BRAF V600E mutation and on at least 1 prior line of systemic therapy and have not had any previous BRAF inhibitor therapy Patients must have measurable disease as defined by RECIST 1.1 See Section 7 for the evaluation of measurable disease. Baseline imaging scan will be used.
3.1.2 Patients must have discontinued prior chemotherapy or targeted therapy at least 14 days prior to D1 of starting study treatment (E+C). Note: patients are allowed to start standard of care treatment with Encorafenib and Cetuximab/panitumumab (prior to registration for up to 14 days).
3.1.3 Patients must be at least 18 years of age.
3.1.4 Patients must exhibit an ECOG performance status of 0 or 1.[Refer Appendix 1]
3.1.5 Patients must have adequate organ and bone marrow function as defined below. If laboratory values are outside these thresholds at screening, repeat labs can be done within a 14 day window. If lab values meet criteria at screening as delineated below, they do not need to be repeated: Leukocytes (WBC) ≥ 3,000/mcL, Absolute neutrophil count (ANC) ≥ 1,500/mcL, Hemoglobin (Hgb) ≥ 9 g/dL, Platelets (PLT) ≥ 100,000/mcL, Total bilirubin ≤ 1.5 x Institutional upper limit of normal (ULN), AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional ULN, or < 5x ULN in presence of liver metastases, Creatinine OR 1.5x ULN OR, Glomerular filtration rate (GFR) > 50 mL/min/1.73 m2

Key exclusion criteria (15 listed)

3.2.1 Patients who have had chemotherapy or radiotherapy ≤ 14 days prior to planned treatment start date. Note: patients are allowed to start standard of care treatment with Encorafenib and Cetuximab (prior to registration for up to 14 days).
3.2.2 Patients who are receiving any other investigational agents for at least 28 days before the first dose of study treatment i.e. C1D1 (which is start of E+C)
3.2.3 Patients receiving treatment with any of the following are not eligible: • Cyclical chemotherapy within a period of time that was shorter than the cycle length for that treatment prior to C1D1(E+C treatment) • Biologic therapy except bevacizumab or aflibercept, continuous or intermittent small molecule therapeutics, within a period of time that is < 5 half-lives or < 28 days prior to starting study treatment • Bevacizumab or aflibercept therapy < 21 days prior to starting study treatment • Radiation therapy including > 30% of the bone marrow. Note: Palliative radiation is allowed at the time of enrollment
3.2.4 Patients with leptomeningeal disease or metastases causing spinal cord compression that are symptomatic or untreated or not stable for ≥ 90 days (must be documented by imaging) or requiring corticosteroids. Subjects on a stable dose of corticosteroids > 28 days of no more than prednisone 10 mg daily or the equivalent, or who have been off of corticosteroids for at least 7 days before C1D1 (E+C), can be enrolled with approval of the medical monitor.
3.2.5 Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to hydroxychloroquine, encorafenib, or cetuximab.

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
Hydroxychloroquine in Combination With Encorafenib and Cetuximab or PanitumumabPrior to starting therapy, patients will have a pretreatment cross-sectional scan. Patients will then begin with encorafenib 300 mg daily starting with Cycle 1 day 1; then patients will receive IV cetuximab weekly, with 400 mg/m2 on C1D1 as a loading dose and 250 mg/m2 on all other days. If desired for patient or physician convenience, q 2 week dosing of cetuximab (at dose of 500 mg/m2) or using the alternate agent panitumumab, also every 2 weeks at a dose of 6 mg/kg IV, can be allowed. The first 14 days of cycle 1 will represent a priming phase, with hydroxychloroquine 400 mg q 12 hour added on C1D15 and continued. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Drug	Treatment (Hydroxychloroquine)

Primary outcome

Objective Response Rate (ORR)
Time frame: Within 30 days (+/- 7 days) of coming off treatment
To determine the ORR by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 criteria for the combination of encorafenib, cetuximab or panitumumab, and hydroxychloroquine. This will be assessed based on RECIST1.1 criteria by cross-sectional imaging done every 2 cycles.

5 secondary outcomes

Progression-Free Survival (PFS)
Time frame: Up to 18 months after end of treatment
Overall Survival (OS)
Time frame: Up to 18 months after end of treatment
Duration of Response (DoR)
Time frame: Up to 18 months after end of treatment
Duration of Stable Disease (DoSD)
Time frame: Up to 18 months after end of treatment
Adverse Events
Time frame: Up to 18 months after end of treatment

Results and safety

The study was stopped early (reason given: The study was closed due to accrual.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.

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.

Devalingam Mahalingam, MD, PhD principal investigator

Northwestern University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 19 inclusion and 15 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 12 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 1 site 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?

The study was stopped early (reason given: The study was closed due to accrual.). 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?

Objective Response Rate (ORR) (time frame: Within 30 days (+/- 7 days) of coming off treatment). 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 NCT05576896.

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 12 Jun 2026.