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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Treatment: Other - HLX60 combined with HLX10

Experimental: HLX60 combined with HLX10 -


Treatment: Other: HLX60 combined with HLX10
five various doses of HLX60 combined with flat dose of HLX10
Intervention code [1] 0 0
Treatment: Other
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
NA
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05483530