Advanced or Metastatic Solid TumorsPhase 1NCT05483530
A Study to Investigate the Safety, Tolerability and Efficacy of HLX60 Combination With HLX10 in Subjects With Advanced or Metastatic Solid Tumors
A Phase 1 study testing HLX60 combined with HLX10 in people with Advanced or Metastatic Solid Tumors, run by Shanghai Henlius Biotech at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic Solid Tumors
- What is being tested?
- HLX60 combined with HLX10
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- 14 Dec 2022to Aug 2025
- 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
- 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.
Who cannot join
- 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/TGFβ complex antibody therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
Accelerated titration and "3 + 3" dose escalation were used in this trial . various doses of HLX60(anti-GARP) combined with HLX10(anti-PD-1) by intravenous infusion.
- Conditions
- Advanced or Metastatic Solid Tumors
- Being tested
- HLX60 combined with HLX10
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX60 combined with HLX10Biological
five various doses of HLX60 combined with flat dose of HLX10
| Study group | Role | What they receive |
|---|---|---|
| HLX60 combined with HLX10 | Experimental | Not described Receives: Biological: HLX60 combined with HLX10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event
Incidence and severity of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 for patients receiving study drug.
Measured: Through study completion, assessed up to 2 years.
Incidence of DLT
Ratio of the number of patients with DLT events in each dose group to the number of patients in the dose group during the DLT evaluation period.
Measured: Up to 3 weeks.
MTD
The maximum tolerated dose (MTD) of HLX60 combined with HLX10
Measured: Up to 3 weeks.
RP2D
The recommended phase II dose (RP2D) of HLX60 combined with HLX10
Measured: Through study completion, assessed up to 2 years.
Secondary outcomes (10)
Objective response rate (ORR)
Percentage of patients with complete response or partial response determined by investigators according to RECIST v1.1
Measured: Through study completion, assessed up to 2 years.
Progression-free survival (PFS)
PFS is defined as the time from the first administration of HLX60 and HLX10 to the first occurrence of disease progression or death due to any cause, whichever occurs first.
Measured: Through study completion, assessed up to 2 years.
Overall survival(OS)
OS is defined as the time from the first administration of HLX60 to death due to any cause.
Measured: Through study completion, assessed up to 2 years.
Cmax
serum concentration (Cmax)
Measured: 1 year
Tmax
time to reach Cmax (Tmax)
Measured: 1 year
t1/2
elimination half-life (t1/2)
Measured: 1 year
AUC
area under the serum concentration-time curve (AUC)
Measured: 1 year
PD
include the GARP receptor occupancy on Treg cells, tumor infiltrating lymphocytes (TILs), FOXP3, pSMAD 2/3 in tumor tissues.
Measured: 1 year
immunogenicity of HLX60
Incidence of HLX60 anti-drug antibody (ADA) and neutralizing antibody (NAb)
Measured: 1 year
Potential prognostic and predictive biomarkers
include the expressions of GARP, PD-L1 in tumor tissues and soluble GARP in peripheral blood.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start14 Dec 2022
- Primary completionDec 2024 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic Solid TumorsStudies of the same condition, open and under way.
- More trials run by Shanghai Henlius BiotechThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483530
- Sponsor's protocol ID
- HLX60HLX10-FIH101
- Status last verified
- Aug 2023
- First submitted
- 6 Jul 2022
- Last updated
- 16 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05483530
- Acronym / sponsor ID
- HLX60HLX10-FIH101
- Conditions
- Advanced or Metastatic Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 14 Dec 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 2 Aug 2022 (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.
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.
Detailed description
Accelerated titration and "3 + 3" dose escalation were used in this trial . various doses of HLX60(anti-GARP) combined with HLX10(anti-PD-1) by intravenous infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HLX60 combined with HLX10 | Experimental | Biological: HLX60 combined with HLX10 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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/TGFβ complex antibody therapy.
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 |
|---|---|---|
| HLX60 combined with HLX10five various doses of HLX60 combined with flat dose of HLX10 | Biological | HLX60 combined with HLX10 |
Primary outcome
Adverse event
Time frame: Through study completion, assessed up to 2 years.
Incidence and severity of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 for patients receiving study drug.
Incidence of DLT
Time frame: Up to 3 weeks.
Ratio of the number of patients with DLT events in each dose group to the number of patients in the dose group during the DLT evaluation period.
MTD
Time frame: Up to 3 weeks.
The maximum tolerated dose (MTD) of HLX60 combined with HLX10
RP2D
Time frame: Through study completion, assessed up to 2 years.
The recommended phase II dose (RP2D) of HLX60 combined with HLX10
10 secondary outcomes
Objective response rate (ORR)
Time frame: Through study completion, assessed up to 2 years.
Progression-free survival (PFS)
Time frame: Through study completion, assessed up to 2 years.
Overall survival(OS)
Time frame: Through study completion, assessed up to 2 years.
Cmax
Time frame: 1 year
Tmax
Time frame: 1 year
t1/2
Time frame: 1 year
AUC
Time frame: 1 year
PD
Time frame: 1 year
immunogenicity of HLX60
Time frame: 1 year
Potential prognostic and predictive biomarkers
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HLX60 combined with HLX10 in people with Advanced or Metastatic Solid Tumors, run by Shanghai Henlius Biotech at 1 site in Australia.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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?
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?
Adverse event (time frame: Through study completion, assessed up to 2 years.). The study lists 4 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 16 Apr 2024.