Advanced/Metastatic HER2-positive Breast, Gastric, Gastroesophageal Junction Cancer With Disease Progression Following Anti-HER2 Standard of Care TreatmentPhase 1/2NCT04467515

A Study to Evaluate Safety, Tolerability, Dosimetry, and Preliminary Efficacy of the HER2 Directed Radioligand CAM-H2 in Patients With Advanced/Metastatic HER2-Positive Breast, Gastric, and Gastro-Esophageal Junction (GEJ) Cancer

A Phase 1/2 study testing CAM-H2 in people with Advanced/Metastatic HER2-positive Breast, Gastric, Gastroesophageal Junction Cancer With Disease Progression Following Anti-HER2 Standard of Care Treatment, run by Precirix at 12 sites in 2 countries.

Terminated

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

Official record

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Trial summary

This is a Phase 1/2 multi-center, open label, dose escalation and dose expansion study to evaluate safety, tolerability, dosimetry, pharmacodynamics (PD), and efficacy of the targeted radionuclide therapeutic CAM-H2 in patients with progressive, advanced/metastatic HER2-positive breast, gastric, and GEJ cancer with… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced/Metastatic HER2-positive Breast, Gastric, Gastroesophageal Junction Cancer With Disease Progression Following Anti-HER2 Standard of Care Treatment
What is being tested?: CAM-H2
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 12 sitesin 2 countries
Study dates: 14 Sep 2021to 11 Dec 2023
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Informed consent form signed voluntarily before any study-related procedure is performed, indicating that the patient understands the purpose of, and procedures required for, the study and is willing to participate in the study;
Males and females ≥ 18 years of age at screening;
Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1;
HER2-positive locally advanced or metastatic breast cancer refractory to standard cancer treatment or HER2-positive locally advanced or metastatic gastric or GEJ cancer, refractory to standard cancer treatment.
Patients should have a minimum of 1 measurable lesion as defined by RECIST version 1.1 or a minimum of 1 measurable lesion as defined by RANO-BM within 4 weeks of the first dose of the study drug (Day 1). The lesion has to be a new lesion or progression of an existing lesion under the current therapy.
Any previous anti-HER2 treatment for advanced or metastatic disease is allowed. Patients with breast cancer should have had at least 2 previous systemic anticancer treatments for recurrent, locally advanced or metastatic cancer. Patients with gastric cancer or GEJ cancer should have had at least 1 previous anti-HER2 treatment.

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Life expectancy > 6 months;
Adequate organ function, determined by the following laboratory tests:
Adequate kidney function with an estimated glomerular filtration rate (eGFR) of >59 mL/minute calculated using the Chronic Kidney Disease Epidemiology Collaboration equation;
Adequate hepatic function defined as an alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2.5 x the upper limit of normal (ULN), or <5 x ULN in patients with liver metastases, and total bilirubin <2 x ULN;
Neutrophil count >1500 cells/mm3 without growth factor support (14 days after last PEGylated granulocyte colony stimulating factor or 7 days after regular granulocyte colony stimulating factor);
Platelet count >100,000 cells/mm3 without platelet transfusion in the last 2 weeks;
Hemoglobin >9.0 g/dL without blood transfusion in the last 2 weeks; and
Adequate coagulation defined as an international normalized ratio (INR) ≤1.5 and activated partial thromboplastin time <1.5 x the upper limit of the institutional normal range;
Baseline left ventricular ejection fraction ≥ 50% as measured by echocardiography or multigated acquisition scan.
Absence of any psychological, family, sociological, or geographical circumstance that could potentially represent an obstacle to compliance with the study protocol and the follow-up schedule, as determined by the Investigator. These circumstances will be discussed with the patient before enrollment in the study; and
Female patients of childbearing potential (ie, ovulating, premenopausal, and not surgically sterile) must have a negative pregnancy test at screening and prior to study drug administration. Patients and their partners of childbearing potential must be willing to use 2 methods of contraception, 1 of which must be a barrier method, for the duration of the study and until 6 months after study drug administration. Medically acceptable barrier methods include condom with spermicide or diaphragm with spermicide. Medically acceptable non-barrier contraceptive methods include intrauterine devices or hormonal contraceptives (oral, implant, injection, ring, or patch).

Who cannot join

Presence of frank leptomeningeal disease as a unique central nervous system feature or in association with brain parenchymal measurable lesion(s);
Symptomatic brain metastases; Note: Patients with asymptomatic treated and untreated brain metastases are eligible.
Previous local therapy for brain metastases, such as neurosurgery, stereotactic radiotherapy, or whole brain radiotherapy, administered within 6 weeks prior to administration of CAM-H2; Note: Previous therapy for brain metastases administered at least 6 weeks prior to CAM-H2 administration will be allowed.
For patients with brain metastases, any increase in corticosteroid dose during the 4 weeks prior to the first administration of CAM-H2.
Note: Corticosteroid treatment in a stable dose or decreasing dose for at least 4 weeks prior to the first administration of CAM-H2 is allowed.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics or psychiatric illness/social situations that would limit compliance with study requirements;

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Uncontrolled thyroid disease, defined as free triiodothyronine (T3) and free thyroxine (T4) > 3 x ULN at screening;
Uncontrolled diabetes defined as a fasting serum glucose > 2 x ULN or glycated hemoglobin levels > 8.5% at screening;
Gastrointestinal (GI) tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption, or uncontrolled inflammatory GI disease (eg, Crohn's, ulcerative colitis);
Current active hepatic or biliary disease (exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease per Investigator assessment);
Ongoing peripheral neuropathy of Grade > 2 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0;
Severe and/or uncontrolled medical conditions or other conditions that could affect participation in the study such as:
Symptomatic congestive heart failure of New York Heart Association Class III or IV;
Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease; or
Liver disease, including cirrhosis and severe hepatic impairment;
Active (acute or chronic) or uncontrolled severe infections;
Known history of HIV, hepatitis B, or active hepatitis C virus at screening;
Prior investigational anticancer therapy within 4 weeks prior to the first administration of CAM-H2.
Patients who have had a major surgery or significant traumatic injury within 4 weeks prior to the first administration of CAM-H2, who have not recovered from side effects of any major surgery (defined as requiring general anesthesia), or have a major surgery planned during the course of the study;
Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin or stage I uterine cancer;
Radiation therapy for metastatic disease foci outside the brain, administered within 3 weeks prior to the first administration of CAM-H2;
Known hypersensitivity to any of the study drugs (including inactive ingredients), including iodine allergy;
History of significant comorbidities that, in the Investigator's judgement, may interfere with study conduct, response assessment, or informed consent;
Unable or unwilling to complete the study procedures;
Patients that cannot be hospitalized in a radionuclide therapy room;
Patients with urinary incontinence;
Patients that are unable to comply with thyroid protective pre-medication;
Patients in whom bladder catheterization cannot be performed, or in patients who are unwilling to be catheterized if necessary;
Patients with contraindications for undergoing MRI or computed tomography (CT), including for receiving contrast agents; or
Patient is the Investigator or sub-Investigator, research assistant, pharmacist, study coordinator, or other staff or relative thereof, who is directly involved in the conduct of the study.

Trial locations and contacts

12 sites in 2 countries.

Country

City, postcode or hospital

12 sites in 2 countries

United States9 sites

Johns Hopkins Hospital
Baltimore, Maryland, 21287
City of Hope
Duarte, California, 91010
Advanced Molecular Imaging & Therapy
Glen Burnie, Maryland, 21061
University of Iowa
Iowa City, Iowa, 52242
Loyola University Medical Center
Maywood, Illinois, 60153
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110
Stanford University Medical Center
Stanford, California, 94305
Georgetown University Medical Center
Washington D.C., District of Columbia, 20057

Other trials in United States

Canada3 sites

Hospital Notre Dame du CHUM
Montreal, Quebec
McGill University Faculty of Medicine - Royal Victoria Hospital
Montreal, Quebec
Princess Margaret Hospital
Toronto, Ontario

Other trials in Canada

About this study

Official title: A Multi-Center Open Label Dose Escalation and Dose Expansion Study to Evaluate Safety, Tolerability, Dosimetry, and Preliminary Efficacy of the HER2 Directed Radioligand CAM-H2 in Patients With Advanced/Metastatic HER2-Positive Breast, Gastric, and GEJ Cancer

Read the detailed description

The study duration for each phase will be up to 18 months. The study is comprised of a Treatment Period, consisting of a maximum of 4 cycles (12 weeks per cycle) of study drug, and a 12-month Long-Term Follow-Up Period.

Conditions: Advanced/Metastatic HER2-positive Breast, Gastric, Gastroesophageal Junction Cancer With Disease Progression Following Anti-HER2 Standard of Care Treatment
Being tested: CAM-H2

What participants receive

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

CAM-H2Drug
All patients will receive at least 1 cycle of CAM-H2. Patients with CB may receive 4 cycles of CAM-H2, each cycle given as 2 IV administrations, 4 weeks apart.

Study groups in NCT04467515
Study group	Role	What they receive
Dose Escalation and Expansion	Experimental	The dose escalation phase of the study will be an open label 3 + 3 design, where at least 3 patients are treated at each dose level. Dose escalation will be done via increases of the nominal activity of CAM-H2 in cohorts of 3 to 6 patients. In the dose expansion phase of the study, the patients will be given the RDP2 determined in the dose escalation phase. Similar to the dose escalation phase, all patients will receive at least 1 cycle of CAM-H2. Receives: Drug: CAM-H2

What is being measured

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

Dose-limiting Toxicity (DLT) Rate Within the First Cycle
Dose-limiting toxicity (DLT) rate of CAM-H2 assessed by toxicities occurring within the first cycle
Measured: Within the first cycle of CAM-H2, up to 12 weeks
Safety and Tolerability - Number of Treatment-emergent Adverse Events (TEAEs)
Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: 18 months

Secondary outcomes (3)

To Assess the Clinical Benefit (CB) of CAM-H2
Evaluate proportion of patients with a Complete Response, Partial Response, and Stable Disease in the dose escalation phase
Measured: 18 months
Anti-drug Antibodies (ADAs) Development
Percentage of patients on CAM-H2 who develop anti-drug antibodies (ADAs)
Measured: 18 months
Dosimetry Efficacy - Total Absorbed Dose
Thirteen patients in 3 different dose levels were evaluated. The total absorbed dose for the 3 source organs (kidneys, liver, red marrow)
Measured: 18 months

Timeline

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

14 Sep 202111 Dec 2023

First posted13 Jul 2020
Study start14 Sep 2021
Primary completion11 Dec 2023
Study completion11 Dec 2023

Why it stopped: Per Strategic Sponsor decision

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Advanced/Metastatic HER2-positive Breast, Gastric, Gastroesophageal Junction Cancer With Disease Progression Following Anti-HER2 Standard of Care TreatmentStudies 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 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Model description: This is a Phase 1/2 multi-center, open label, dose escalation and dose expansion study to evaluate safety, tolerability, dosimetry, PD, and efficacy of the targeted radionuclide therapeutic CAM H2 in patients with progressive, advanced/metastatic HER2 positive breast, gastric, and GEJ cancer with disease progression following anti-HER2 standard of care treatment. The study is comprised of a Treatment Period, consisting of a maximum of 4 cycles (12 weeks per cycle) of study drug, and a Long Term Follow Up Period. The study will be comprised of the following: * Dose Escalation Phase Followed by a Long Term Follow Up (LTFU) period * Dose Expansion Phase Followed by a LTFU period In the dose expansion phase of the study, the patients will be given the recommended dose for Phase 2 (RDP2) determined in the dose escalation phase. Similar to the dose escalation phase, all patients will receive at least 1 cycle of CAM-H2.
Masking: None (open label)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04467515
Sponsor's protocol ID: CAMH2_1001
Status last verified: Apr 2025
First submitted: 10 Jun 2020
Last updated: 6 May 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

D'Huyvetter M, Vos J, Caveliers V, Vaneycken I, Heemskerk J, Duhoux FP, Fontaine C, Vanhoeij M, Windhorst AD, Aa FV, Hendrikse NH, Eersels JLE, Everaert H, Gykiere P, Devoogdt N, Raes G, Lahoutte T, Keyaerts M. Phase I Trial of 131I-GMIB-Anti-HER2-VHH1, a New Promising Candidate for HER2-Targeted Radionuclide Therapy in Breast Cancer Patients. J Nucl Med. 2021 Aug 1;62(8):1097-1105. doi: 10.2967/jnumed.120.255679. Epub 2020 Dec 4.
PubMed 33277400

Study at a glance

From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center Open Label Dose Escalation and Dose Expansion Study to Evaluate Safety, Tolerability, Dosimetry, and Preliminary Efficacy of the HER2 Directed Radioligand CAM-H2 in Patients With Advanced/Metastatic HER2-Positive Breast, Gastric, and GEJ Cancer
ClinicalTrials.gov ID: NCT04467515
Acronym / sponsor ID: CAMH2_1001
Conditions: Advanced/Metastatic HER2-positive Breast, Gastric, Gastroesophageal Junction Cancer With Disease Progression Following Anti-HER2 Standard of Care Treatment
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Per Strategic Sponsor decision
Enrolment: 13 participants (actual)
Lead sponsor: PrecirixIndustry (pharma, biotech, devices)
Study start: 14 Sep 2021 (actual)
Primary completion: 11 Dec 2023 (actual)
Study completion: 11 Dec 2023 (actual)
First posted: 13 Jul 2020 (actual)
Results: Posted 6 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1
Model description: This is a Phase 1/2 multi-center, open label, dose escalation and dose expansion study to evaluate safety, tolerability, dosimetry, PD, and efficacy of the targeted radionuclide therapeutic CAM H2 in patients with progressive, advanced/metastatic HER2 positive breast, gastric, and GEJ cancer with disease progression following anti-HER2 standard of care treatment. The study is comprised of a Treatment Period, consisting of a maximum of 4 cycles (12 weeks per cycle) of study drug, and a Long Term Follow Up Period. The study will be comprised of the following: * Dose Escalation Phase Followed by a Long Term Follow Up (LTFU) period * Dose Expansion Phase Followed by a LTFU period In the dose expansion phase of the study, the patients will be given the recommended dose for Phase 2 (RDP2) determined in the dose escalation phase. Similar to the dose escalation phase, all patients will receive at least 1 cycle of CAM-H2.

Arm	Type	Receives
Dose Escalation and Expansion	Experimental	Drug: CAM-H2The dose escalation phase of the study will be an open label 3 + 3 design, where at least 3 patients are treated at each dose level. Dose escalation will be done via increases of the nominal activity of CAM-H2 in cohorts of 3 to 6 patients. In the dose expansion phase of the study, the patients will be given the RDP2 determined in the dose escalation phase. Similar to the dose escalation phase, all patients will receive at least 1 cycle of CAM-H2.

Who may qualify

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

Key inclusion criteria (17 listed)

Informed consent form signed voluntarily before any study-related procedure is performed, indicating that the patient understands the purpose of, and procedures required for, the study and is willing to participate in the study;
Males and females ≥ 18 years of age at screening;
Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1;
HER2-positive locally advanced or metastatic breast cancer refractory to standard cancer treatment or HER2-positive locally advanced or metastatic gastric or GEJ cancer, refractory to standard cancer treatment.
Patients should have a minimum of 1 measurable lesion as defined by RECIST version 1.1 or a minimum of 1 measurable lesion as defined by RANO-BM within 4 weeks of the first dose of the study drug (Day 1). The lesion has to be a new lesion or progression of an existing lesion under the current therapy.

Key exclusion criteria (30 listed)

Presence of frank leptomeningeal disease as a unique central nervous system feature or in association with brain parenchymal measurable lesion(s);
Symptomatic brain metastases; Note: Patients with asymptomatic treated and untreated brain metastases are eligible.
Previous local therapy for brain metastases, such as neurosurgery, stereotactic radiotherapy, or whole brain radiotherapy, administered within 6 weeks prior to administration of CAM-H2; Note: Previous therapy for brain metastases administered at least 6 weeks prior to CAM-H2 administration will be allowed.
For patients with brain metastases, any increase in corticosteroid dose during the 4 weeks prior to the first administration of CAM-H2.
Note: Corticosteroid treatment in a stable dose or decreasing dose for at least 4 weeks prior to the first administration of CAM-H2 is allowed.

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
CAM-H2All patients will receive at least 1 cycle of CAM-H2. Patients with CB may receive 4 cycles of CAM-H2, each cycle given as 2 IV administrations, 4 weeks apart.	Drug	Dose Escalation and Expansion

Primary outcome

Dose-limiting Toxicity (DLT) Rate Within the First Cycle
Time frame: Within the first cycle of CAM-H2, up to 12 weeks
Dose-limiting toxicity (DLT) rate of CAM-H2 assessed by toxicities occurring within the first cycle
Safety and Tolerability - Number of Treatment-emergent Adverse Events (TEAEs)
Time frame: 18 months
Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

3 secondary outcomes

To Assess the Clinical Benefit (CB) of CAM-H2
Time frame: 18 months
Anti-drug Antibodies (ADAs) Development
Time frame: 18 months
Dosimetry Efficacy - Total Absorbed Dose
Time frame: 18 months

Results and safety

Results posted to the registry on 6 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1 CAM-H2 (2 x 1.85 GBq)	3	1
Cohort 2 CAM-H2 (2 x 3.7) GBq	3	1
Cohort 3 CAM-H2 (2 x 5.55) GBq	7	3

Primary outcome: Dose-limiting Toxicity (DLT) Rate Within the First Cycle

Time frame: Within the first cycle of CAM-H2, up to 12 weeks. Number. Unit: DLTs

Measure	Cohort 1 CAM-H2 (2 x 1.85 GBq) n = 3	Cohort 2 CAM-H2 (2 x 3.7) GBq n = 3	Cohort 3 CAM-H2 (2 x 5.55) GBq n = 7
Value	0	0	1

Population analysed: Any Dose-Limiting Toxicities (DLTs) that occur during the first cycle by patients

Primary outcome: Safety and Tolerability - Number of Treatment-emergent Adverse Events (TEAEs)

Time frame: 18 months. Number. Unit: Adverse Events

Measure	Cohort 1 CAM-H2 (2 x 1.85 GBq) n = 3	Cohort 2 CAM-H2 (2 x 3.7) GBq n = 3	Cohort 3 CAM-H2 (2 x 5.55) GBq n = 7
Grade 1 - Mild	27	24	43
Grade 2 - Moderate	7	6	22
Grade 3 - Severe	2	3	8
Grade 4 - Life-Threatening	0	0	0
Grade 5 - Death	0	0	0

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were monitored from time signing informed consent through study completion, an average of 18 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1 CAM-H2 (2 x 1.85 GBq)	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Cohort 2 CAM-H2 (2 x 3.7) GBq	1 of 3 (33.3%)	3 of 3 (100%)	2 of 3
Cohort 3 CAM-H2 (2 x 5.55) GBq	1 of 7 (14.3%)	7 of 7 (100%)	3 of 7

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33277400D'Huyvetter M, Vos J, Caveliers V, Vaneycken I, Heemskerk J, Duhoux FP, Fontaine C, Vanhoeij M, Windhorst AD, Aa FV, Hendrikse NH, Eersels JLE, Everaert H, Gykiere P, Devoogdt N, Raes G, Lahoutte T, Keyaerts M. Phase I Trial of 131I-GMIB-Anti-HER2-VHH1, a New Promising Candidate for HER2-Targeted Radionuclide Therapy in Breast Cancer Patients. J Nucl Med. 2021 Aug 1;62(8):1097-1105. doi: 10.2967/jnumed.120.255679. Epub 2020 Dec 4.

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.

Jonathan Delara study director

Precirix

12 sites in 2 countries: 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 17 inclusion and 30 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 6 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 12 sites in United States, Canada. 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 combined 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.

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?

Yes. Results are posted in the registry (first posted 6 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Dose-limiting Toxicity (DLT) Rate Within the First Cycle (time frame: Within the first cycle of CAM-H2, up to 12 weeks). 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?

On the ClinicalTrials.gov record for NCT04467515, 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 6 May 2025.