Clinical Trials Directory

Trials / Unknown

UnknownNCT05390528

A Study Evaluating the Safety, Tolerability, Pharmacokinetic and Efficacy of HLX301(TIGIT×PDL1 Bispecific) in Locally Advanced/Metastatic Solid Tumors or Lymphoma

A Phase I/II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics and Initial Efficacy of HLX301(TIGIT×PDL1 Bispecific) in Patients With Locally Advanced/Metastatic Solid Tumors or Lymphoma

Status
Unknown
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
Shanghai Henlius Biotech · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

A Phase 1/2 Study of HLX301, A Recombinant Humanized Anti-PDL1 and Anti-TIGIT Bispecific Antibody, in patients with locally advanced/metastatic solid tumors or lymphoma.Up to 150 patients will be included in this study. Up to 30 DLT evaluable patients will be enrolled in phase 1a (dose escalation), 40 per-protocol treated patients in phase 1b (dose expansion), and 80 per-protocol treated patients in phase 2. Phase 1a to evaluate safety, dose limiting toxicity (DLT), and the maximum tolerated dose (MTD) of HLX301 in patients with advanced or metastatic tumors who have failed or are intolerant to standard therapy, or for whom no standard therapy is available.Phase 1b to identify the recommended phase 2 dose (RP2D) of HLX301 in patients with advanced or metastatic NSCLC who have failed or are intolerant to standard therapy, or for whom no standard therapy is available. Phase 2 to evaluate the anti-tumor activity of HLX301 in patients with histologically or cytologically-confirmed non-small cell lung cancer (NSCLC), gastric/esophagogastric junction adenocarcinoma (GC/EGJ), head and neck squamous cell carcinoma (HNSCC), or urothelial carcinoma (UC) tumors that express PD-L1, after one or two prior systemic treatments and without standard therapy。

Conditions

Interventions

TypeNameDescription
DRUGHLX301HLX301 will be administered as a single intravenous (IV) infusion on Day1 in each 14-day cycle.

Timeline

Start date
2022-06-20
Primary completion
2023-09-01
Completion
2024-12-30
First posted
2022-05-25
Last updated
2023-08-08

Locations

2 sites across 1 country: China

Source: ClinicalTrials.gov record NCT05390528. Inclusion in this directory is not an endorsement.