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Trial Title:
A Study to Investigate the Safety, Tolerability and Efficacy of HLX60 Combination With HLX10 in Subjects With Advanced or Metastatic Solid Tumors
NCT ID:
NCT05483530
Condition:
Advanced or Metastatic Solid Tumors
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
HLX60 combined with HLX10
Description:
five various doses of HLX60 combined with flat dose of HLX10
Arm group label:
HLX60 combined with HLX10
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.
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.
Criteria for eligibility:
Criteria:
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.
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/TGFβ complex antibody therapy.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Macquarie University Hospital & Nepean Hospital
Address:
City:
Sydney
Country:
Australia
Start date:
December 14, 2022
Completion date:
August 2025
Lead sponsor:
Agency:
Shanghai Henlius Biotech
Agency class:
Industry
Source:
Shanghai Henlius Biotech
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05483530