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HLX301 (TIGIT×PDL1 Bispecific) in Patients With Locally Advanced or Metastatic Solid Tumors
This Phase 1/2, multicenter, first-in-human, open-label, dose-escalation, dose expansion, and clinical expansion study will evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy of HLX301 administered as a single-agent by IV infusion every 2 weeks to patients with locally advanced or metastatic solid malignancies, who have failed or are intolerant to standard therapy, or for whom no standard therapy is available. This study has three parts: phase 1a dose escalation, phase 1b dose expansion, and phase 2 clinical expansion.
Study details:
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 uses the Bayesian optimal interval (BOIN) design, to investigate the safety and determine the MTD of HLX301.
BOIN design combines rule-based and model-based design, allowing for flexibility of dose escalation and de-escalation, and high patient enrollment in doses closest to the target toxicity rate (pre-defined as 30% in this study). This study will also evaluate safety profiles at different dose levels, PK parameters, pharmacodynamic markers, immunogenicity, and the preliminary efficacy of the drug. Following dose escalation and determination of the MTD, additional patients with NSCLC will be enrolled in phase 1b dose expansion to further evaluate PK and pharmacodynamic characteristics, and preliminary efficacy in order to determine the RP2D.
The phase 2 clinical expansion will include patients with various cancer types, including:. 20 per-protocol treated patients with non-small cell lung cancer (NSCLC) 20 per-protocol treated patients with gastric/esophagogastric junction adenocarcinoma (GC/EGJ) 20 per-protocol treated patients with head and neck squamous cell carcinoma (HNSCC) 20 per-protocol treated patients with urothelial carcinoma (UC).
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2022-05-03
Primary completion: 2023-09-15
Study completion finish: 2024-02-01
Study type
TREATMENT
Phase
PHASE1
PHASE2
Trial ID
NCT05102214
Intervention or treatment
DRUG: HLX301
Conditions
- • Locally Advanced or Metastatic Solid Tumors
- • Non-small Cell Lung Cancer
Find a site
Closest Location:
Blacktown Hospital
Research sites nearby
Select from list below to view details:
Blacktown Hospital
Blacktown, New South Wales, Australia
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
Sunshine Coast University Private Hospital
Birtinya, Queensland, Australia
Southern Oncology Clinical Research Unit
Adelaide, South Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Phase 1a dose-escalation stage
| DRUG: HLX301
|
EXPERIMENTAL: Phase 1b dose-expansion stage
| DRUG: HLX301
|
EXPERIMENTAL: Phase 2 clinical expansion stage: Cohort A
| DRUG: HLX301
|
EXPERIMENTAL: Phase 2 clinical expansion stage: Cohort B
| DRUG: HLX301
|
EXPERIMENTAL: Phase 2 clinical expansion stage: Cohort C
| DRUG: HLX301
|
EXPERIMENTAL: Phase 2 clinical expansion stage: Cohort D
| DRUG: HLX301
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Phase 1a: Safety assessments in patients receiving the trial drug | including incidence, nature, and severity of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 | 2 years |
Phase 1a: The proportion of patients experiencing dose limiting toxicity (DLT) events | Not Specified | From baseline to the end of cycle 2 (28 days) |
Phase 1a: The maximum tolerated dose (MTD) of HLX301 | Not Specified | From baseline to the end of cycle 2 (28 days) |
Phase 1b: Recommended phase 2 dose (RP2D) | One of the two doses in phase 1b with a more favorable safety profile, a favorable PK/PD/ADA profile, and potential clinical efficacy will be selected as the recommended phase 2 dose (RP2D) | From baseline to 48 weeks after first infusion |
Phase 2: Objective response rate (ORR) defined as achieving a complete response or partial response as determined by the investigator according to RECIST v1.1 | Objective response rate (ORR) defined as achieving a complete response or partial response as determined by the investigator according to RECIST v1.1 • Disease control rate (DCR) defined as achieving the complete response, partial response, or stable disease as determined by the investigator according to RECIST v1.1 | 2 years |
Phase 2: Disease control rate (DCR) defined as achieving the complete response, partial response, or stable disease as determined by the investigator according to RECIST v1.1 | Not Specified | 2 years |
Phase 2: Duration of response (DOR) defined as the time from the first occurrence of a documented ORR to disease progression, as determined by the investigator according to RECIST v1.1 | Not Specified | 2 years |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Phase 1a: The pharmacokinetic parameters of HLX301: Peak concentration (Cmax, Cmax,ss) | Not Specified | 2 years |
Phase 1a: The pharmacokinetic parameters of HLX301: Time to peak (Tmax, Tmax,ss) | Not Specified | 2 years |
Phase 1a: The pharmacokinetic parameters of HLX301: Area under the concentration-time curve (AUC0-inf, AUC0-t, AUCss) | Not Specified | 2 years |
Phase 1a: The pharmacokinetic parameters of HLX301: Elimination half-life (t1/2) | Not Specified | 2 years |
Phase 1a: The pharmacokinetic parameters of HLX301: Clearance (CL, CLss) | Not Specified | 2 years |
Phase 1a: The pharmacokinetic parameters of HLX301: Volume of distribution (Vz, Vss) | Not Specified | 2 years |
Phase 1a: The pharmacodynamic profiles of HLX301 as determined by receptor occupancy of HLX301 on circulating T cells | Not Specified | 2 years |
Phase 1a: The incidence of treatment-emergent anti-drug antibodies (ADA) of HLX301 | Not Specified | 2 years |
Phase 1b: The preliminary efficacy as determined by ORR | Not Specified | 2 years |
Phase 1b: The preliminary efficacy as determined by DCR | Not Specified | 2 years |
Phase 1b: The preliminary efficacy as determined by DOR | Not Specified | 2 years |
Phase 2: The safety profile | assessing incidence, nature, and severity of adverse events according to NCI CTCAE v5.0 | 2 years |
Phase 2: To investigate the correlation between PD-L1 expression levels and anti-tumor activity of HLX301 in patients with NSCLC, GC/EJC, HNSCC and UC | Not Specified | 2 years |
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