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

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-14
• Study Completion Date: 2025-08-31

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HLX60 combined with HLX10

Group Type: EXPERIMENTAL

HLX60 combined with HLX10

Intervention Type: BIOLOGICAL

five various doses of HLX60 combined with flat dose of HLX10

Interventions

HLX60 combined with HLX10

five various doses of HLX60 combined with flat dose of HLX10

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Henlius Biotech

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Macquarie University Hospital & Nepean Hospital

Sydney, , Australia

Countries

Australia

Other Identifiers

HLX60HLX10-FIH101

Identifier Type: -

Identifier Source: org_study_id