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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06685718




Registration number
NCT06685718
Ethics application status
Date submitted
11/11/2024
Date registered
12/11/2024
Date last updated
13/01/2025

Titles & IDs
Public title
A Study Investigating BG-60366 in Adults With Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer
Scientific 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
Secondary ID [1] 0 0
2024-517322-26-00
Secondary ID [2] 0 0
BG-60366-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 0 0
Lung Cancer 0 0
NSCLC 0 0
NSCLC (Non-small Cell Lung Carcinoma) 0 0
EGFR Activating Mutation 0 0
EGFR Mutation-Related Tumors 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BG-60366

Experimental: Phase 1a: Dose Escalation and Safety Expansion - Sequential cohorts of increasing dose levels of BG-60366 will be evaluated as monotherapy.

Experimental: Phase 1b: Dose Expansion - Recommended Dose(s) for Expansion (RDFE\[s\]) of BG-60366 as monotherapy determined from Phase 1a will be evaluated.


Treatment: Drugs: BG-60366
Administered orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [1] 0 0
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)
Primary outcome [2] 0 0
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD)
Timepoint [2] 0 0
Approximately 1 month
Primary outcome [3] 0 0
Phase 1a: Recommended dose(s) for expansion (RDFE) of BG-60366
Timepoint [3] 0 0
Approximately 18 months
Primary outcome [4] 0 0
Phase 1b: Number of Participants with Adverse Events and Serious Adverse Events
Timepoint [4] 0 0
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)
Primary outcome [5] 0 0
Phase 1b: Overall Response Rate (ORR)
Timepoint [5] 0 0
Approximately 24 months
Secondary outcome [1] 0 0
Phase 1a: Overall Response Rate (ORR)
Timepoint [1] 0 0
Approximately 24 months
Secondary outcome [2] 0 0
Phase 1a and 1b: Duration of Response (DOR)
Timepoint [2] 0 0
Approximately 24 months
Secondary outcome [3] 0 0
Phase 1a and 1b: Time to Response (TTR)
Timepoint [3] 0 0
Approximately 24 months
Secondary outcome [4] 0 0
Phase 1b: Progression-Free Survival (PFS)
Timepoint [4] 0 0
Approximately 24 months
Secondary outcome [5] 0 0
Phase 1b: Disease Control Rate (DCR)
Timepoint [5] 0 0
Approximately 24 months
Secondary outcome [6] 0 0
Phase 1a and 1b: Maximum observed plasma concentration (Cmax) of BG-60366
Timepoint [6] 0 0
Twice in the first 3 months
Secondary outcome [7] 0 0
Phase 1a and 1b: Time to reach maximum observed plasma concentration (Tmax) of BG-60366
Timepoint [7] 0 0
Twice in the first 3 months
Secondary outcome [8] 0 0
Phase 1a and 1b: Apparent terminal elimination half-life (t1/2) of BG-60366
Timepoint [8] 0 0
Twice in the first 3 months
Secondary outcome [9] 0 0
Phase 1a and 1b: Area under the concentration-time curve (AUC) for BG-60366
Timepoint [9] 0 0
Twice in the first 3 months
Secondary outcome [10] 0 0
Phase 1a and 1b: Minimum observed plasma concentration (Cmin) of BG-60366
Timepoint [10] 0 0
Twice in the first 3 months
Secondary outcome [11] 0 0
Phase 1a and 1b: Apparent total clearance (CL/F) of BG-60366
Timepoint [11] 0 0
Twice in the first 3 months
Secondary outcome [12] 0 0
Phase 1a and 1b: Apparent volume of distribution (Vz/F) of BG-60366
Timepoint [12] 0 0
Twice in the first 3 months
Secondary outcome [13] 0 0
Phase 1a and 1b: Accumulation Ratio (AR) of BG-60366
Timepoint [13] 0 0
Once in the first three months
Secondary outcome [14] 0 0
Phase 1a and 1b: Plasma concentrations of BG-60366
Timepoint [14] 0 0
Approximately up to 6 months

Eligibility
Key inclusion criteria
* 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
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/11/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2028
Actual
Sample size
Target
93
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Blacktown Cancer and Haematology Centre - Blacktown
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [4] 0 0
Cancer Research South Australia - Adelaide
Recruitment hospital [5] 0 0
Austin Health - Heidelberg
Recruitment hospital [6] 0 0
Peter Maccallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
4102 - Brisbane
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
Recruitment postcode(s) [6] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Brazil
State/province [8] 0 0
Barretos
Country [9] 0 0
Brazil
State/province [9] 0 0
Natal
Country [10] 0 0
Brazil
State/province [10] 0 0
Porto Alegre
Country [11] 0 0
Brazil
State/province [11] 0 0
Salvador
Country [12] 0 0
Brazil
State/province [12] 0 0
Sao Jose do Rio Preto
Country [13] 0 0
Brazil
State/province [13] 0 0
Sao Paulo
Country [14] 0 0
Brazil
State/province [14] 0 0
Vitoria
Country [15] 0 0
China
State/province [15] 0 0
Beijing
Country [16] 0 0
China
State/province [16] 0 0
Guangdong
Country [17] 0 0
China
State/province [17] 0 0
Guangxi
Country [18] 0 0
China
State/province [18] 0 0
Jiangxi
Country [19] 0 0
China
State/province [19] 0 0
Tianjin
Country [20] 0 0
China
State/province [20] 0 0
Zhejiang
Country [21] 0 0
Italy
State/province [21] 0 0
Bologna
Country [22] 0 0
Italy
State/province [22] 0 0
Monza
Country [23] 0 0
Italy
State/province [23] 0 0
Roma
Country [24] 0 0
Malaysia
State/province [24] 0 0
Kuching
Country [25] 0 0
New Zealand
State/province [25] 0 0
Auckland
Country [26] 0 0
Spain
State/province [26] 0 0
Barcelona
Country [27] 0 0
Spain
State/province [27] 0 0
Madrid
Country [28] 0 0
Thailand
State/province [28] 0 0
Bangkok

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
BeiGene
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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). 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.
Trial website
https://clinicaltrials.gov/study/NCT06685718
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
BeiGene
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Director
Address 0 0
Country 0 0
Phone 0 0
1.877.828.5568
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06685718