A Study to Investigate the Safety, Tolerability and Efficacy of HLX60 Combination With HLX10 in Subjects With Advanced or Metastatic Solid Tumors

NCT05483530 | Unknown Phase 1

• 1 other identifier: HLX60HLX10-FIH101
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced or Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  Up to 3 weeks.

• MTD

  The maximum tolerated dose (MTD) of HLX60 combined with HLX10

  Up to 3 weeks.

• RP2D

  The recommended phase II dose (RP2D) of HLX60 combined with HLX10

  Through study completion, assessed up to 2 years.

Secondary Outcomes (10)

• Objective response rate (ORR)

  Through study completion, assessed up to 2 years.

• Progression-free survival (PFS)

  Through study completion, assessed up to 2 years.

• Overall survival(OS)

  Through study completion, assessed up to 2 years.

• Cmax

  1 year

• Tmax

  1 year

Study Arms (1)

HLX60 combined with HLX10

EXPERIMENTAL

Biological: HLX60 combined with HLX10

Interventions

HLX60 combined with HLX10 BIOLOGICAL

five various doses of HLX60 combined with flat dose of HLX10

HLX60 combined with HLX10

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

Study Sites (1)

Macquarie University Hospital & Nepean Hospital

Sydney, Australia

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: August 2, 2022
• Study Start: December 14, 2022
• Primary Completion: December 1, 2024
• Study Completion: August 1, 2025
• Last Updated: April 16, 2024

Record last verified: 2023-08

Locations

AU (1)