RecruitingPhase 1NCT06427941

A Phase 1 Study of BGB-B2033, Alone or in Combination With Tislelizumab With or Without Bevacizumab, in Participants With Advanced or Metastatic Solid Tumors

A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-B2033, Alone or in Combination With Tislelizumab With or Without Bevacizumab, in Participants With Selected Advanced or Metastatic Solid Tumors


Sponsor

BeOne Medicines

Enrollment

140 participants

Start Date

Jul 23, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a first-in-human (FIH) clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor activity of BGB-B2033 administered as monotherapy and in combination with tislelizumab, with or without bevacizumab. The study will enroll participants with locally advanced or metastatic hepatocellular carcinoma (HCC), alpha-fetoprotein (AFP)-producing gastric cancer (GC), extragonadal yolk sac tumors/non-dysgerminomas, or glypican-3 (GPC3)-positive squamous non-small cell lung cancer (NSCLC).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an early-phase study testing a new cancer drug called BGB-B2033, given alone or combined with other immunotherapy drugs (tislelizumab and/or bevacizumab), in people with advanced or spread cancers. The cancers being studied include liver cancer, a type of stomach cancer that produces a protein called AFP, germ cell tumors, and a specific type of lung cancer that tests positive for a protein called GPC3. **You may be eligible if...** - You have one of these advanced cancers: liver cancer (hepatocellular carcinoma), AFP-producing stomach cancer, germ cell tumors with no remaining curative options, or GPC3-positive squamous lung cancer that has been treated with a checkpoint inhibitor - Your cancer cannot be surgically removed or has spread - You are in generally good health and able to carry out daily activities (ECOG 0–1) - You have at least one tumor that can be measured on scans - Your organ function (liver, kidneys, blood counts) is within acceptable ranges **You may NOT be eligible if...** - You have previously received a drug that targets GPC3 or the immune receptor 4-1BB - You have cancer that has spread to the lining of the brain (leptomeningeal disease) or uncontrolled brain metastases - You have an active autoimmune disease or a history of one likely to flare up - You have another cancer diagnosed in the past 2 years (with limited exceptions) - You require high-dose steroids or immunosuppressants - You have significant lung, heart, or bleeding conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBGB-B2033

Administered by intravenous infusion

DRUGTislelizumab

Administered by intravenous infusion

DRUGBevacizumab

Administered by intravenous infusion


Locations(20)

Memorial Sloan Kettering Cancer Center Mskcc

New York, New York, United States

Upmc Hillman Cancer Center(Univ of Pittsburgh)

Pittsburgh, Pennsylvania, United States

Scri Oncology Partners

Nashville, Tennessee, United States

Anhui Provincial Hospital

Hefei, Anhui, China

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian, China

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The Second Affiliated Hospital of Nanchang Universityhongjiaozhou Branch

Nanchang, Jiangxi, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Auckland City Hospital

Auckland, New Zealand

Hospital Oncologico

Rio Piedras, Puerto Rico

Cha Bundang Medical Center, Cha University

BundangGu SeongnamSi, Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Samsung Medical Center

GangnamGu, Seoul Teugbyeolsi, South Korea

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi, South Korea

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, South Korea

Asan Medical Center

SongpaGu, Seoul Teugbyeolsi, South Korea

View Full Details on ClinicalTrials.gov

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NCT06427941


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