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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05483530




Registration number
NCT05483530
Ethics application status
Date submitted
6/07/2022
Date registered
2/08/2022
Date last updated
16/04/2024

Titles & IDs
Public title
A Study to Investigate the Safety, Tolerability and Efficacy of HLX60 Combination With HLX10 in Subjects With Advanced or Metastatic Solid Tumors
Scientific title
A Phase 1 Clinical Study to Investigate the Safety, Tolerability and Efficacy of HLX60 (Anti-GARP Monoclonal Antibody) Combination With HLX10 (Anti-PD-1 Monoclonal Antibody) in Subjects With Advanced or Metastatic Solid Tumors
Secondary ID [1] 0 0
HLX60HLX10-FIH101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced or Metastatic Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - HLX60 combined with HLX10

Experimental: HLX60 combined with HLX10 -


Other interventions: HLX60 combined with HLX10
five various doses of HLX60 combined with flat dose of HLX10
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse event
Timepoint [1] 0 0
Through study completion, assessed up to 2 years.
Primary outcome [2] 0 0
Incidence of DLT
Timepoint [2] 0 0
Up to 3 weeks.
Primary outcome [3] 0 0
MTD
Timepoint [3] 0 0
Up to 3 weeks.
Primary outcome [4] 0 0
RP2D
Timepoint [4] 0 0
Through study completion, assessed up to 2 years.
Secondary outcome [1] 0 0
Objective response rate (ORR)
Timepoint [1] 0 0
Through study completion, assessed up to 2 years.
Secondary outcome [2] 0 0
Progression-free survival (PFS)
Timepoint [2] 0 0
Through study completion, assessed up to 2 years.
Secondary outcome [3] 0 0
Overall survival(OS)
Timepoint [3] 0 0
Through study completion, assessed up to 2 years.
Secondary outcome [4] 0 0
Cmax
Timepoint [4] 0 0
1 year
Secondary outcome [5] 0 0
Tmax
Timepoint [5] 0 0
1 year
Secondary outcome [6] 0 0
t1/2
Timepoint [6] 0 0
1 year
Secondary outcome [7] 0 0
AUC
Timepoint [7] 0 0
1 year
Secondary outcome [8] 0 0
PD
Timepoint [8] 0 0
1 year
Secondary outcome [9] 0 0
immunogenicity of HLX60
Timepoint [9] 0 0
1 year
Secondary outcome [10] 0 0
Potential prognostic and predictive biomarkers
Timepoint [10] 0 0
1 year

Eligibility
Key inclusion criteria
- Patients with histologically or cytologically confirmed advanced malignant solid
tumor, who have failed or cannot receive the standard treatment;

- With at least one evaluable lesion according to RECIST v1.1 (for solid tumors);

- Patients must be able to supply adequate tumor tissue for biomarker (including the
expression of PD-L1, GARP) analyses;

- Life expectancy longer than three months;

- Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0
to 1.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Has a concurrently active second malignancy, other than adequately treated
non-melanoma skin cancers, in situ melanoma or in situ cervical cancer. Participants
with history of the second malignancy have been disease-free for <3 years.

- Has a history of (non-infectious) interstitial lung disease (ILD) that required
steroids, currently has ILD, or when suspected ILD cannot be ruled out by imaging at
screening.

- Participant has unresolved AEs = Grade 2 from prior anticancer therapy except for
alopecia.

- Those who have received anti-GARP or anti-GARP/TGFß complex antibody therapy.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Macquarie University Hospital & Nepean Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Shanghai Henlius Biotech
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the study is to evaluate the safety and tolerability of HLX60 combined with
HLX10 in order to determine the maximum tolerated dose (MTD) and Recommended Phase 2 dose
(RP2D) and to evaluate the preliminary efficacy for each combination regimen.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05483530
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries