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A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of HLX35 in Combination With HLX10 in Patients With Advanced or Metastatic Solid Tumors

NCT05442996 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-07-05

No results posted yet for this study

Summary

This is a phase I clinical study designed to evaluate the safety, tolerability, PK characteristics, and preliminary efficacy of HLX35 in combination with HLX10 in patients with advanced or metastatic solid tumors.

Conditions

  • Solid Tumor, Adult

Interventions

DRUG

HLX35

The dose of HLX35 is set at 0.1 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg, and 10 mg/kg. It is administered intravenously every 2 weeks on day 1 of each cycle.

DRUG

HLX10

The dose of HLX10 is fixed at 200 mg. It is administered intravenously once every 2 weeks on day 1 of each cycle.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-06
Primary Completion
2024-04-22
Completion
2025-04-22

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05442996 on ClinicalTrials.gov