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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

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