A Phase 1 Study of BGB-B2033, Alone or in Combination With Tislelizumab, in Participants With Advanced or Metastatic Solid Tumors

Description

This study is a first-in-human (FIH) Phase 1 study of BGB-B2033 to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of the BGB-B2033 in participants with 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). The study will also identify the recommended Phase 2 dose (RP2D) of BGB-B2033 alone and in combination with tislelizumab for subsequent studies. BGB-B2033 will be administered by intravenous infusion. The Phase 1 study will be conducted in 2 parts: Part A (Monotherapy Dose Escalation and Safety Expansion) and Part B (Combination Dose Escalation and Safety Expansion).

Conditions

Metastatic Hepatocellular Carcinoma, Advanced Hepatocellular Carcinoma, Alpha-fetoprotein (AFP)-Producing Gastric Cancer, Extragonadal Yolk Sac Tumors, Glypican-3 (GPC3)-Positive Squamous Non-small Cell Lung Cancer, Metastatic Solid Tumor

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Study Overview

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Study Details

Study overview

This study is a first-in-human (FIH) Phase 1 study of BGB-B2033 to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of the BGB-B2033 in participants with 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). The study will also identify the recommended Phase 2 dose (RP2D) of BGB-B2033 alone and in combination with tislelizumab for subsequent studies. BGB-B2033 will be administered by intravenous infusion. The Phase 1 study will be conducted in 2 parts: Part A (Monotherapy Dose Escalation and Safety Expansion) and Part B (Combination Dose Escalation and Safety Expansion).

A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-B2033, Alone or in Combination With Tislelizumab, in Participants With Selected Advanced or Metastatic Solid Tumors

A Phase 1 Study of BGB-B2033, Alone or in Combination With Tislelizumab, in Participants With Advanced or Metastatic Solid Tumors

Condition
Metastatic Hepatocellular Carcinoma
Intervention / Treatment

-

Contacts and Locations

Nashville

Scri Oncology Partners, Nashville, Tennessee, United States, 37203

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Participants with any of the following unresectable locally advanced or metastatic tumor types:
  • 1. HCC
  • 2. AFP-producing GC (serum AFP \> 20 ng/mL or tumor tissue AFP positive by a validated IHC assay according to local testing criteria)
  • 3. germ cell tumor including extragonadal yolk sac tumors (located in mediastinum, vagina, brain, and retroperitoneum, etc) and non-dysgerminomas
  • 4. GPC3-positive squamous NSCLC
  • 2. ≥ 1 evaluable lesion for dose escalation and ≥ 1 measurable lesion for safety expansion, per RECIST v1.1
  • 3. ECOG Performance Status score ≤ 1
  • 4. Adequate organ functions
  • 5. Tumor tissues will be required for certain parts of the study
  • 1. Prior therapy targeting glypican-3 (GPC3) or the T-cell costimulatory receptor 4-1BB (also known as CD137)
  • 2. Active leptomeningeal disease or uncontrolled, untreated brain metastasis
  • 3. Active autoimmune diseases or history of autoimmune diseases that may relapse
  • 4. Any malignancy ≤ 2 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent
  • 5. Any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study drug(s).
  • 6. Certain comorbidities in the lung, heart, bleeding condition and infections.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

BeiGene,

Study Director, STUDY_DIRECTOR, BeiGene

Study Record Dates

2026-10-30