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

NCT05650385 | Unknown Phase 1

• 1 other identifier: TSL-B1962-01
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Neoplasms Malignant

Outcome Measures

Primary Outcomes (6)

• DLT Assessment

  Toxicity associated with the treatment of the investigational drug B1962

  From Day1 to Day15 after first dose of B1962

• AE Assessment

  The frequency of AE

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

• 12-lead ECG Assessment

  Changes of 12-lead ECG from baseline

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

• Eastern Cooperative Oncology Group score Assessment

  Changes of Eastern Cooperative Oncology Group score from baseline

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

• Determine the maximum tolerated dose (MTD)

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

• Determine the recommended phase II dose (RP2D)

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

Secondary Outcomes (5)

• Peak Plasma Concentration (Cmax) Analysis

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

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

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

• Terminal elimination half-life(t1/2) Analysis

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

• Time to reach the maximum observed concentration(Tmax) Analysis

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

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

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

Study Arms (10)

Cohort 1

EXPERIMENTAL

B1962 0.035mg Open Lable

Drug: B1962

Cohort 2

EXPERIMENTAL

B1962 0.12mg Open Lable

Drug: B1962

Cohort 3

EXPERIMENTAL

B1962 0.4mg Open Lable

Drug: B1962

Cohort 4

EXPERIMENTAL

B1962 1.2mg Open Lable

Drug: B1962

Cohort 5

EXPERIMENTAL

B1962 4mg Open Lable

Drug: B1962

Cohort 6

EXPERIMENTAL

B1962 8mg Open Lable

Drug: B1962

Cohort 7

EXPERIMENTAL

B1962 11mg Open Lable

Drug: B1962

Cohort 8

EXPERIMENTAL

B1962 15mg Open Lable

Drug: B1962

Cohort 9

EXPERIMENTAL

B1962 20mg Open Lable

Drug: B1962

Cohort 10

EXPERIMENTAL

B1962 25mg Open Lable

Drug: B1962

Interventions

B1962 DRUG

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

Cohort 1; Cohort 10; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6; Cohort 7; Cohort 8; Cohort 9

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Tasly Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200082, China

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Kongli zhu, Master

  Tasly Biopharmaceuticals Co., Ltd.

  STUDY CHAIR

Central Study Contacts

Kongli zhu, Master

CONTACT

+8615800363686; tsl-zhukongli@tasly.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: December 14, 2022
• Study Start: December 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: October 1, 2025
• Last Updated: December 14, 2022

Record last verified: 2022-11

Locations

CN (1)