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Neoplasms MalignantPhase 1NCT05650385

A Study of B1962, a PD-L1/VEGF Bispecific Antibody Fusion Protein, for Advanced Solid Tumors

A Phase 1 study testing B1962 in people with Neoplasms Malignant, run by Tasly Biopharmaceuticals Co., Ltd. at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This study is to characterize the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of B1962, a PD-L1/VEGF bispecific antibody fusion protein, as a single agent in adult subjects with advanced solid tumor malignancies. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Neoplasms Malignant
What is being tested?
B1962
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteChina
Study dates
Dec 2022to Oct 2025
Phase
Phase 1
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • written and signed informed consent.
  • Age ≥ 18 years and ≤ 75 years at the time of signing the informed consent form.
  • Patients with histologically or cytologically confirmed advanced malignant solid tumors who have failed or failed to respond to standard therapy, or who are intolerant of standard therapy, or who have no standard effective treatment regimen, or who have refused standard therapy (posterior and endline).
  • willing and able to comply with all study procedures.
  • Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.
  • Life expectancy ≥ 3 months.
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  • Subjects must have at least one measurable lesion according to RECIST Version 1.1
  • Adequate organ and bone marrow function
  • Females of childbearing potential and non-sterilized males who are sexually active must use an effective method of contraception from screening until 120 days after final dose of investigational product or women of non child bearing potential.

Who cannot join

  • Patients receiving immune checkpoint inhibitors (ICIs) or VEGF/VEGFR inhibitors within 28 days prior to the first dose of the study drug.
  • Known allergy or reaction to any component of the B1962 formulation or history of severe hypersensitivity reactions to other large protein agents/mAbs or BsAbs.
  • Female patients who are pregnant or breastfeeding.
  • Subjects has received major surgical procedure within 4 weeks prior to the first dose of B1962, or is scheduled to receive major surgical procedure during the current study period
  • Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v5.0 Grade 0 or 1 (except for alopecia).
  • Patients with untreated or clinically symptomatic brain metastases, spinal cord compression, cancerous meningitis, or other evidence that the patient's brain or spinal cord metastases have not been controlled (except in cases where the patient has been treated and has stable symptoms, imaging shows stability for at least 4 weeks prior to the first dose, and there is no evidence of brain edema and no need for glucocorticoid therapies)
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  • Patients with clinically symptomatic or recurrent pleural effusions, pericardial effusions or ascites requiring repeated drainage
  • Imaging at the screening period showed that the tumor was wrapped around important blood vessels or had significant necrosis or cavitiation, and the investigators judged that entering the study would cause bleeding risk
  • Known history of HIV infection or acquired immunodeficiency syndrome-related disease
  • Patients with hepatitis B or C infection; or known active syphilis infection.
  • Uncontrolled infections requiring systemic therapy within 4 weeks prior to the first dose of study drug.
  • Subjects with clinically significant cardiovascular disease; uncontrolled hypertension (SBP ≥ 140 mmHg or DBP ≥ 90 mmHg) or poor compliance with antihypertensive therapy; major vascular disease.
  • History of Coagulation disorders, bleeding disorders, or other conditions judged by the investigator to be a risk of bleeding within 6 months prior to the first dose.
  • pulmonary hemorrhage/hemoptysis ≥ grade 2 (according to NCI-CTCAE v5.0) within 1 month prior to first drug administration
  • biopsy or other minor surgery, excluding placement of vascular access devices, within 7 days prior to the first dose of B1962
  • History of arterial or venous thrombosis, or stroke or transient ischemic attack within 6 months prior to the first dose of B1962
  • Current unstable dose of anticoagulant or thrombolytic medication within 14 days of the first dose of B1962. Note: prophylactic use of low molecular heparin is acceptable.
  • Aspirin (> 325 mg/day) or NSAIDs treatment within 14 days of first dose of B1962
  • Uncontrolled diabetes mellitus (HbA1c >8%) on standard therapy
  • Active or prior documented idiopathic pulmonary fibrosis or idiopathicpneumonia; current acute lung disease, interstitial lung disease or pneumonia (except localized interstitial pneumonia due to radiotherapy induction), pulmonary fibrosis, etc.; severe respiratory distress, pulmonary insufficiency or continuous oxygenation
  • Active or prior documented of autoimmune disease requiring systemic therapy within 2 years prior to screening. Note: Enrollment is permitted in the following conditions: hypothyroidism that can be controlled by hormone replacement therapy alone, skin conditions that do not require systemic therapy (e.g. vitiligo, psoriasis), and controlled celiac disease.
  • Subjects with a condition requiring systemic treatment with either corticosteroid (> 10 mg daily ) or other immunosuppressive medications within 14 days of first study drug administration (topical or physiological hormones dose is acceptable)
  • Receipt of any systemic anticancer therapy within 4 weeks or 5 half-lives (whichever is longer) prior to first dose, small molecule tyrosine kinase-targeted agents therapy or immunomodulatory therapy within 2 weeks prior to first dose; or herbal or proprietary Chinese medicines with antitumor indications within 1 week prior to the first dose.
  • For hepatocellular carcinoma: receipt of local area treatment of the liver within 4 weeks prior to the first dose of B1962
  • History of organ or hematopoietic stem cell transplantation requiring immunosuppressive medications
  • History of other neoplasms within 5 years prior to screening, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or cervical cancer in situ that has undergone successful radical surgery
  • Received attenuated vaccination within 4 weeks prior to screening or planning to receive attenuated vaccination during the study period
  • Patients who have participated in a clinical study and received study drug within 4 weeks or 5 half-lives (whichever is longer) prior to the first dose
  • History of alcohol or drug abuse within 12 months prior to the first dose.
  • Known history of psychiatric disorder that may affect trial compliance
  • Other serious systemic disease, abnormal laboratory tests, or other reasons deemed inappropriate for subjects by the investigator

Trial locations and contacts

1 site in 1 country.

Kongli zhu, Master contact

+8615800363686

tsl-zhukongli@tasly.com

China1 site

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200082

    Caicun Zhou, MD, +86021-65115006-305, caicunzhoudr@163.com

Other trials in China

About this study

Official title: A Multicenter, Open-label, Dose-escalating Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of B1962 Injection in the Treatment of Advanced Malignant Solid Tumors

This study is to characterize the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of B1962, a PD-L1/VEGF bispecific antibody fusion protein, as a single agent in adult subjects with advanced solid tumor malignancies. The study consists of two parts: a once-weekly (QW) dosing phase and a biweekly (Q2W) dosing phase, which will explore the possibility of Q2W dosing of B1962 based on the PK data obtained in the QW phase. The study will determine the maximum tolerated dose (MTD), or recommended Phase 2 dose (RP2D) for B1962 as a single agent.

Being tested
B1962
Medical subject headings
Neoplasms

What participants receive

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

  • B1962Drug

    B1962 is a PD-L1/VEGF bispecific antibody fusion protein.

Study groups in NCT05650385
Study groupRoleWhat they receive
Cohort 1ExperimentalB1962 0.035mg Open Lable
Receives: Drug: B1962
Cohort 2ExperimentalB1962 0.12mg Open Lable
Receives: Drug: B1962
Cohort 3ExperimentalB1962 0.4mg Open Lable
Receives: Drug: B1962
Cohort 4ExperimentalB1962 1.2mg Open Lable
Receives: Drug: B1962
Cohort 5ExperimentalB1962 4mg Open Lable
Receives: Drug: B1962
Cohort 6ExperimentalB1962 8mg Open Lable
Receives: Drug: B1962
Cohort 7ExperimentalB1962 11mg Open Lable
Receives: Drug: B1962
Cohort 8ExperimentalB1962 15mg Open Lable
Receives: Drug: B1962
Cohort 9ExperimentalB1962 20mg Open Lable
Receives: Drug: B1962
Cohort 10ExperimentalB1962 25mg Open Lable
Receives: Drug: B1962

What is being measured

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

  1. DLT Assessment

    Toxicity associated with the treatment of the investigational drug B1962

    Measured: From Day1 to Day15 after first dose of B1962

  2. AE Assessment

    The frequency of AE

    Measured: From first dose of B1962 until 28 days after the last dose of B1962.

  3. 12-lead ECG Assessment

    Changes of 12-lead ECG from baseline

    Measured: From first dose of B1962 until 28 days after the last dose of B1962.

  4. Eastern Cooperative Oncology Group score Assessment

    Changes of Eastern Cooperative Oncology Group score from baseline

    Measured: From first dose of B1962 until 28 days after the last dose of B1962.

  5. Determine the maximum tolerated dose (MTD)

    Measured: From first dose of B1962 until 28 days after the last dose of B1962

  6. Determine the recommended phase II dose (RP2D)

    Measured: From first dose of B1962 until 28 days after the last dose of B1962

Secondary outcomes (5)

  1. Peak Plasma Concentration (Cmax) Analysis

    Measured: From first dose of B1962 through 7 days of deciding to stop research treatment by subjects

  2. Area under the plasma concentration versus time curve (AUC) Analysis

    Measured: From first dose of B1962 through 7 days of deciding to stop research treatment by subjects

  3. Terminal elimination half-life(t1/2) Analysis

    Measured: From first dose of B1962 through 7 days of deciding to stop research treatment by subjects

  4. Time to reach the maximum observed concentration(Tmax) Analysis

    Measured: From first dose of B1962 through 7 days of deciding to stop research treatment by subjects

  5. Number of subjects who develop detectable anti-drug antibodies (ADAs)

    Measured: From first dose of B1962 until 28 days after the last dose of B1962

Timeline

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

  1. First posted14 Dec 2022
  2. Study startDec 2022 (estimated)
  3. Primary completionDec 2023 (estimated)
  4. Study completionOct 2025 (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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05650385
Sponsor's protocol ID
TSL-B1962-01
Status last verified
Nov 2022
First submitted
9 Nov 2022
Last updated
14 Dec 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing B1962 in people with Neoplasms Malignant, run by Tasly Biopharmaceuticals Co., Ltd. at 1 site 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 9 inclusion and 31 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 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 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.

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?

Contact Kongli zhu, Master (+8615800363686, tsl-zhukongli@tasly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLT Assessment (time frame: From Day1 to Day15 after first dose of B1962). The study lists 6 primary outcomes in all. 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 NCT05650385.

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 14 Dec 2022.

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