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Advanced TumorsPhase 1/2HLX301NCT05390528

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

A Phase 1/2 study testing HLX301 in people with Advanced Tumors and Lymphoma, run by Shanghai Henlius Biotech at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Tumors, Lymphoma, Metastatic Tumors
What is being tested?
HLX301
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesChina
Study dates
20 Jun 2022to 30 Dec 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects who meet each of the following criteria are eligible for inclusion:
  • Patients who meet the following criteria will be enrolled:
  • Phase 1a dose escalation: patients must have histologically or cytologically confirmed malignant solid tumors which are advanced or metastatic, have failed prior standard treatment, and be intolerant or ineligible for standard therapy (with the exception of hepatocellular carcinoma, which meets diagnostic criteria by dynamic CT/MRI).
  • Age ≥ 18 years, or legally an adult as per local regulations.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Measurable disease according to RECIST Version 1.1
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  • Able to provide informed consent.
  • A life expectancy longer than three months.
  • Adequate hematologic parameters, defined as white blood cell count ≥ 3000/mm3 and absolute neutrophil counts ≥ 1500/mm3; hemoglobin≥9gm/dL; platelet count ≥ 90,000/mm3 without platelet transfusion within 14 days.
  • Adequate hepatic function, defined as serum albumin ≥ 3.0 g/dL; serum total bilirubin ≤ 1.5x upper limit of normal (ULN); serum aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 x ULN (AST and ALT ≤ 5 × ULN for patients with known liver metastasis or primary hepatocellular carcinoma); Child-Pugh score A in HCC.
  • Adequate renal function, defined as serum creatinine ≤ 1.5x upper limit of normal (ULN).
  • Adequate cardiac function defined as left ventricular ejection fraction (LVEF) ≥ 50% measured by cardiac ultrasound or MUGA scan; normal ECG or ECG without any clinically significant findings.

Who cannot join

  • Subjects who meet any of the following criteria will be excluded from the study:
  • Received prior anti-TIGIT therapy.
  • Patients who still have persistent ≥ grade 2 toxicities from prior therapies.
  • Concurrent unstable or uncontrolled medical conditions including, but not limited to, the following:
  • Ongoing or active systemic infections requiring antibiotic treatment ii. Clinically significant arrhythmia, unstable angina pectoris, class III or IV congestive heart failure as per the New York Heart Association, or acute myocardial infarction in the past 6 months iii. Unhealed wound or ulcers persisting ≥ 3 months iv. Psychiatric illness or a social situation that would preclude study compliance v. Any other diseases, metabolic dysfunction, physical examination findings, or laboratory results raising reasonable suspicion of a disease or condition that contraindicates use of the investigational drug, that may affect interpretation of results, or that may place the patient at high risk of treatment complications.
  • Active CNS metastasis indicated by clinical symptoms, cerebral edema, steroid requirements (not including maintenance low dose steroids), or progressive growth.
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  • History of any secondary malignancy in the past 2 years with the exception of curatively treated non-melanoma skin cancer or treated cervical carcinoma in situ.
  • Active or a history of (in the past 2 years) of autoimmune disease or syndrome requiring systemic steroid or immunosuppressive agents.
  • History of interstitial lung disease.
  • Hepatitis B virus infection (HBsAg or anti-HBc positive, and HBV-DNA positive), hepatitis C virus infection (anti-HCV positive, and HCV-RNA positive), or co-infection with hepatitis B and hepatitis C (positive HBsAg or anti-HBc, and positive anti-HCV).
  • Human immunodeficiency virus (HIV) infection.
  • Major surgery, treatment with anti-cancer or investigational agents, or radiotherapy in the 28 days prior to the first study dosing.
  • Treatment with immune check point inhibitors (anti-PD-1 or anti-PD-L1) in the 42 days prior to the first study dosing.
  • Pregnancy or breast-feeding.
  • Patients of reproductive age who are unable to use effective contraceptive measures in the period from the first dose of study drug to 180 days following the last dose of study drug. Female patients who have been amenorrheic for at least 12 months, have had a hysterectomy or oophorectomy, or have been surgically sterilized do not require contraception.

Trial locations and contacts

2 sites in 1 country.

China2 sites, 2 recruiting

  • Jilin Provincial Cancer Hospital

    Changchun, Jilin

    Ying Cheng, Doctor, 0431-80596315, jl.cheng@163.com

    Ying Cheng, Doctor

    Recruiting

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

    Yuping Sun, Doctor, 13370582181, 13370582181@163.com

    Yuping Sun, Doctor

    Recruiting

Other trials in China

About this study

Official title: 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

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。

Being tested
HLX301
Medical subject headings
Lymphoma, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HLX301Drug

    Also called A Recombinant Humanized Anti-PDL1 and Anti-TIGIT Bispecific Antibody

    HLX301 will be administered as a single intravenous (IV) infusion on Day1 in each 14-day cycle.

Study groups in NCT05390528
Study groupRoleWhat they receive
Experimental Group(phase Ia)ExperimentalPhase 1a uses accelerated titration design and Bayesian optimal interval (BOIN) design to investigate the safety of HLX301 and determine MTD.Six dose levels of 0.25 mg/kg, 1 mg/kg, 2.5 mg/kg, 5 mg/kg, 10 mg/kg, and 20mg/kg are planned for dose finding.
Receives: Drug: HLX301

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1a: The incidence, nature, and severity of adverse events according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 in patients receiving the trial drug

    Including grading of the incidence, nature, and severity of adverse events according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0

    Measured: up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2022
  2. Study start20 Jun 2022
  3. Primary completion1 Sep 2023 (estimated)
  4. Study completion30 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05390528
Sponsor's protocol ID
HLX301-002
Acronym
HLX301
Status last verified
Apr 2023
First submitted
25 Apr 2022
Last updated
8 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HLX301 in people with Advanced Tumors and Lymphoma, run by Shanghai Henlius Biotech at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1a: The incidence, nature, and severity of adverse events according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 in patients receiving the trial drug (time frame: up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05390528.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.

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