Non-Small Cell Lung CancerPhase 1NCT06685718
A Study Investigating BG-60366 in Adults With Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer
A Phase 1 study testing BG-60366 in people with Non-Small Cell Lung Cancer and Lung Cancer, run by BeOne Medicines at 29 sites in 7 countries.
Trial summary
This is an open-label, multicenter, Phase 1a/1b clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BG-60366, a highly potent, selective EGFR-mutation targeted Chimeric Degradation Activation Compound (CDAC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer, Lung Cancer, NSCLC
- What is being tested?
- BG-60366
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 29 sitesin 7 countries
- Study dates
- 5 Dec 2024to 21 Apr 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed diagnosis of NSCLC, carrying an EGFR activating mutation prior to receiving standard EGFR-tyrosine kinase inhibitor (EGFR-TKI)
- Phase 1a general inclusion criteria:
- Disease progression on prior third-generation EGFR-TKI for advanced or metastatic disease, and either progressed or ineligible for currently available standard-of-care treatment (eg, platinum-based chemotherapy) after EGFR-TKI treatment
- Phase 1a safety expansion
- Documentation of EGFR resistance mutations (ie, C797s)
- At least ≥ 1 evaluable lesion (for Phase 1a Dose Escalation) or at least ≥ 1 measurable lesion (for Phase 1a Safety Expansion or Phase 1b Dose Expansion) per RECIST v1.1
Show all 9Show fewer
- EGFR resistance mutations may be detected locally either from tumor tissue or circulating tumor DNA (ctDNA) in blood, and samples used for detection of resistance mutations must be collected after progression on the most recent systemic antitumor treatment
- Adequate organ function
- Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
Who cannot join
- Any previous histologic or cytologic evidence of small cell or combined small cell/non-small cell disease in the archival tumor tissue or tumor biopsy before enrollment
- Symptomatic spinal cord compression
- Brain metastases which are symptomatic and/or requiring emergency treatment (eg, starting steroid, or stereotactic radiation/whole-brain radiation within 2 weeks before first dose of study drug)
- Prior treatment with fourth-generation EGFR-TKI, other CDAC/proteolysis-targeting chimeras (PROTAC) compounds targeting EGFR mutations, or other drugs with the mechanism of action specifically targeting EGFR resistance mutations (eg, C797X) (except for the first- to third-generation EGFR-TKIs)
- Any history of interstitial lung disease (ILD) or ≥ Grade 2 noninfectious pneumonitis ≤ 2 years before the first dose of study drug, or has current ILD/noninfectious pneumonitis, or where suspected active ILD/noninfectious pneumonitis cannot be ruled out by imaging during screening
- Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
29 sites in 7 countries.
29 sites in 7 countries
China7 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Guangdong Provincial Peoples Hospital Huifu Branch
Guangzhou, Guangdong, 510120
Sir Run Run Shaw Hospital, Zhejiang University School of Medicineqiantang Branch
Hangzhou, Zhejiang, 310018
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
The Tumor Hospital Affiliated to Guangxi Medical Universitywuxiang Branch
Nanning, Guangxi, 530201
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
United States6 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02215-5418
Ohio State University
Columbus, Ohio, 43210-1132
University of Colorado
Denver, Colorado, 80202-1702
The University of Texas Md Anderson Cancer Center
Houston, Texas, 77030-4009
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, 10065-6800
Washington University School of Medicine Siteman Cancer Center
St Louis, Missouri, 63110-1032
Australia6 sites
Cancer Research South Australia
Adelaide, South Australia, SA 5000
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, NSW 2148
Austin Health
Heidelberg, Victoria, VIC 3084
Liverpool Hospital
Liverpool, New South Wales, NSW 2170
Peter Maccallum Cancer Centre
Melbourne, Victoria, VIC 3000
Princess Alexandra Hospital
Woolloongabba, Queensland, QLD 4102
South Korea4 sites
Chungbuk National University Hospital
Cheongju-si, Chungcheongbukdo, 28644
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, 06351
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, 03722
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 03080
Spain3 sites
Hospital Universitario Vall Dhebron
Barcelona, 08035
Hospital Universitario 12 de Octubre
Madrid, 28041
H Puerta de Hierro Majadahonda
Majadahonda, 28222
Italy2 sites
Fondazione Irccs San Gerardo Dei Tintori Sc Oncologia
Monza, 20900
Fondazione Policlinico Universitario Agostino Gemelli
Roma, 00168
About this study
Official title: Phase 1a/1b, Open-Label Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of a CDAC Degrading EGFR, BG-60366, in Patients With EGFR-Mutant Non-Small Cell Lung Cancer
This is an open-label, multicenter, Phase 1a/1b clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BG-60366, a highly potent, selective EGFR-mutation targeted Chimeric Degradation Activation Compound (CDAC). BG-60366 is designed to degrade mutant EGFR, which is a common cause for Non-Small Cell Lung Cancer (NSCLC). This study will evaluate how well BG-60366 works in participants with advanced or metastatic EGFR-mutant NSCLC.
The study will be conducted in 2 parts: 1) Phase 1a Dose Escalation and Safety Expansion, and 2) Phase 1b Dose Expansion.
Read the detailed description
Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
- Conditions
- Non-Small Cell Lung Cancer, Lung Cancer, NSCLC, NSCLC (Non-small Cell Lung Carcinoma), EGFR Activating Mutation, EGFR Mutation-Related Tumors
- Being tested
- BG-60366
- Keywords
- lung cancer, non-small cell lung cancer, NSCLC, EGFR activating mutation, EGFR resistant mutation, advanced or metastatic non-small cell lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BG-60366Drug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a: Dose Escalation and Safety Expansion | Experimental | Sequential cohorts of increasing dose levels of BG-60366 will be evaluated as monotherapy. Receives: Drug: BG-60366 |
| Phase 1b: Dose Expansion | Experimental | Recommended Dose(s) for Expansion (RDFE[s]) of BG-60366 as monotherapy determined from Phase 1a will be evaluated. Receives: Drug: BG-60366 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with AEs and SAEs, including findings from laboratory assessments, electrocardiograms (ECGs), and physical examinations, and that meet protocol-defined dose-limiting toxicity (DLT) criteria.
Measured: From first dose of the study drug to 30 days after the last dose or initiation of a new anticancer therapy, whichever occurs first (approximately 18 months)
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD)
MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate. MAD is defined as the highest dose administered if MTD is not reached.
Measured: Approximately 1 month
Phase 1a: Recommended dose(s) for expansion (RDFE) of BG-60366
RDFE of BG-60366 will be determined based upon the MTD or MAD.
Measured: Approximately 18 months
Phase 1b: Number of Participants with Adverse Events and Serious Adverse Events
Number of participants with AEs and SAEs, including findings from physical examinations, ECGs, and laboratory assessments as needed.
Measured: From first dose of the study drug to 30 days after the last dose or initiation of a new anticancer therapy, whichever occurs first (approximately 24 months)
Phase 1b: Overall Response Rate (ORR)
ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Measured: Approximately 24 months
Secondary outcomes (14)
Phase 1a: Overall Response Rate (ORR)
ORR is defined as the percentage of participants who had confirmed CR or PR assessed by the investigator using RECIST v1.1.
Measured: Approximately 24 months
Phase 1a and 1b: Duration of Response (DOR)
DOR is defined as the time from the first determination of objective response that is confirmed by the subsequent assessment until the first documentation of disease progression or death, whichever comes first.
Measured: Approximately 24 months
Phase 1a and 1b: Time to Response (TTR)
TTR is defined as the time from the date of the first dose of study drugs to the date of teh first determination of objective response that is confirmed by the subsequent assessment.
Measured: Approximately 24 months
Phase 1b: Progression-Free Survival (PFS)
PFS is defined as the time from the date of the first dose of study drug to the date of the first documentation of disease progression assessed by the investigator using RECIST v1.1 or death, whichever occurs first.
Measured: Approximately 24 months
Phase 1b: Disease Control Rate (DCR)
DCR is defined as the percentage of participants with the best overall response of confirmed CR, PR, or stable disease assessed.
Measured: Approximately 24 months
Phase 1a and 1b: Maximum observed plasma concentration (Cmax) of BG-60366
Measured: Twice in the first 3 months
Phase 1a and 1b: Time to reach maximum observed plasma concentration (Tmax) of BG-60366
Measured: Twice in the first 3 months
Phase 1a and 1b: Apparent terminal elimination half-life (t1/2) of BG-60366
Measured: Twice in the first 3 months
Phase 1a and 1b: Area under the concentration-time curve (AUC) for BG-60366
Measured: Twice in the first 3 months
Phase 1a and 1b: Minimum observed plasma concentration (Cmin) of BG-60366
Measured: Twice in the first 3 months
Phase 1a and 1b: Apparent total clearance (CL/F) of BG-60366
Measured: Twice in the first 3 months
Phase 1a and 1b: Apparent volume of distribution (Vz/F) of BG-60366
Measured: Twice in the first 3 months
Phase 1a and 1b: Accumulation Ratio (AR) of BG-60366
Measured: Once in the first three months
Phase 1a and 1b: Plasma concentrations of BG-60366
Measured: Approximately up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start5 Dec 2024
- Primary completion21 Apr 2026
- Study completion21 Apr 2026
Why it stopped: Evaluation on business strategy, not involving safety issue.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by BeOne MedicinesThe 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeOne Medicines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeOne Medicines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685718
- Sponsor's protocol ID
- BG-60366-101
- Other IDs
- 2024-517322-26-00, CTR20250272
- Status last verified
- May 2026
- First submitted
- 11 Nov 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1a/1b, Open-Label Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of a CDAC Degrading EGFR, BG-60366, in Patients With EGFR-Mutant Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06685718
- Acronym / sponsor ID
- BG-60366-101
- Conditions
- Non-Small Cell Lung Cancer, Lung Cancer, NSCLC, NSCLC (Non-small Cell Lung Carcinoma), EGFR Activating Mutation, EGFR Mutation-Related Tumors
- Keywords
- lung cancer, non-small cell lung cancer, NSCLC, EGFR activating mutation, EGFR resistant mutation, advanced or metastatic non-small cell lung cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Evaluation on business strategy, not involving safety issue.
- Enrolment
- 33 participants (actual)
- Lead sponsor
- BeOne MedicinesIndustry (pharma, biotech, devices)
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- 21 Apr 2026 (actual)
- Study completion
- 21 Apr 2026 (actual)
- First posted
- 12 Nov 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.
This is an open-label, multicenter, Phase 1a/1b clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BG-60366, a highly potent, selective EGFR-mutation targeted Chimeric Degradation Activation Compound (CDAC). BG-60366 is designed to degrade mutant EGFR, which is a common cause for Non-Small Cell Lung Cancer (NSCLC). This study will evaluate how well BG-60366 works in participants with advanced or metastatic EGFR-mutant NSCLC.
The study will be conducted in 2 parts: 1) Phase 1a Dose Escalation and Safety Expansion, and 2) Phase 1b Dose Expansion.
Detailed description
Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1a: Dose Escalation and Safety Expansion | Experimental | Drug: BG-60366Sequential cohorts of increasing dose levels of BG-60366 will be evaluated as monotherapy. |
| Phase 1b: Dose Expansion | Experimental | Drug: BG-60366Recommended Dose(s) for Expansion (RDFE[s]) of BG-60366 as monotherapy determined from Phase 1a will be evaluated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically or cytologically confirmed diagnosis of NSCLC, carrying an EGFR activating mutation prior to receiving standard EGFR-tyrosine kinase inhibitor (EGFR-TKI)
- Phase 1a general inclusion criteria:
- Phase 1a safety expansion
- At least ≥ 1 evaluable lesion (for Phase 1a Dose Escalation) or at least ≥ 1 measurable lesion (for Phase 1a Safety Expansion or Phase 1b Dose Expansion) per RECIST v1.1
- EGFR resistance mutations may be detected locally either from tumor tissue or circulating tumor DNA (ctDNA) in blood, and samples used for detection of resistance mutations must be collected after progression on the most recent systemic antitumor treatment
Key exclusion criteria (7 listed)
- Any previous histologic or cytologic evidence of small cell or combined small cell/non-small cell disease in the archival tumor tissue or tumor biopsy before enrollment
- Symptomatic spinal cord compression
- Brain metastases which are symptomatic and/or requiring emergency treatment (eg, starting steroid, or stereotactic radiation/whole-brain radiation within 2 weeks before first dose of study drug)
- Prior treatment with fourth-generation EGFR-TKI, other CDAC/proteolysis-targeting chimeras (PROTAC) compounds targeting EGFR mutations, or other drugs with the mechanism of action specifically targeting EGFR resistance mutations (eg, C797X) (except for the first- to third-generation EGFR-TKIs)
- Any history of interstitial lung disease (ILD) or ≥ Grade 2 noninfectious pneumonitis ≤ 2 years before the first dose of study drug, or has current ILD/noninfectious pneumonitis, or where suspected active ILD/noninfectious pneumonitis cannot be ruled out by imaging during screening
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 |
|---|---|---|
| BG-60366Administered orally | Drug | Phase 1a: Dose Escalation and Safety Expansion, Phase 1b: Dose Expansion |
Primary outcome
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From first dose of the study drug to 30 days after the last dose or initiation of a new anticancer therapy, whichever occurs first (approximately 18 months)
Number of participants with AEs and SAEs, including findings from laboratory assessments, electrocardiograms (ECGs), and physical examinations, and that meet protocol-defined dose-limiting toxicity (DLT) criteria.
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD)
Time frame: Approximately 1 month
MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate. MAD is defined as the highest dose administered if MTD is not reached.
Phase 1a: Recommended dose(s) for expansion (RDFE) of BG-60366
Time frame: Approximately 18 months
RDFE of BG-60366 will be determined based upon the MTD or MAD.
Phase 1b: Number of Participants with Adverse Events and Serious Adverse Events
Time frame: From first dose of the study drug to 30 days after the last dose or initiation of a new anticancer therapy, whichever occurs first (approximately 24 months)
Number of participants with AEs and SAEs, including findings from physical examinations, ECGs, and laboratory assessments as needed.
Phase 1b: Overall Response Rate (ORR)
Time frame: Approximately 24 months
ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
14 secondary outcomes
Phase 1a: Overall Response Rate (ORR)
Time frame: Approximately 24 months
Phase 1a and 1b: Duration of Response (DOR)
Time frame: Approximately 24 months
Phase 1a and 1b: Time to Response (TTR)
Time frame: Approximately 24 months
Phase 1b: Progression-Free Survival (PFS)
Time frame: Approximately 24 months
Phase 1b: Disease Control Rate (DCR)
Time frame: Approximately 24 months
Phase 1a and 1b: Maximum observed plasma concentration (Cmax) of BG-60366
Time frame: Twice in the first 3 months
Phase 1a and 1b: Time to reach maximum observed plasma concentration (Tmax) of BG-60366
Time frame: Twice in the first 3 months
Phase 1a and 1b: Apparent terminal elimination half-life (t1/2) of BG-60366
Time frame: Twice in the first 3 months
Phase 1a and 1b: Area under the concentration-time curve (AUC) for BG-60366
Time frame: Twice in the first 3 months
Phase 1a and 1b: Minimum observed plasma concentration (Cmin) of BG-60366
Time frame: Twice in the first 3 months
Phase 1a and 1b: Apparent total clearance (CL/F) of BG-60366
Time frame: Twice in the first 3 months
Phase 1a and 1b: Apparent volume of distribution (Vz/F) of BG-60366
Time frame: Twice in the first 3 months
Phase 1a and 1b: Accumulation Ratio (AR) of BG-60366
Time frame: Once in the first three months
Phase 1a and 1b: Plasma concentrations of BG-60366
Time frame: Approximately up to 6 months
Results and safety
The study was stopped early (reason given: Evaluation on business strategy, not involving safety issue.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Yes. BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
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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.
Study Director study director
BeOne Medicines
29 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BG-60366 in people with Non-Small Cell Lung Cancer and Lung Cancer, run by BeOne Medicines at 29 sites in 7 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 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in China, United States, Australia, South Korea, Spain and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Evaluation on business strategy, not involving safety issue.). 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?
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: From first dose of the study drug to 30 days after the last dose or initiation of a new anticancer therapy, whichever occurs first (approximately 18 months)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.