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

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

NCT ID: NCT06427941

Condition: 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

Conditions: Official terms:
Carcinoma
Neoplasms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Carcinoma, Hepatocellular
Stomach Neoplasms
Endodermal Sinus Tumor
Tislelizumab

Conditions: Keywords:
HCC
GC
GPC-3
GPC3-positive squamous non-small cell lung cancer
NSCLC
BGB-B2033
tislelizumab
metastatic hepatocellular carcinoma
advanced hepatocellular carcinoma
alpha-fetoprotein (AFP)-producing gastric cancer
extragonadal yolk sac tumors
squamous non-small-cell lung cancer
Non-dysgerminomas

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: BGB-B2033
Description: Administered by intravenous infusion
Arm group label: Part A (Monotherapy Dose Escalation and Safety Expansion)
Arm group label: Part B (Combination Dose Escalation and Safety Expansion)

Intervention type: Drug
Intervention name: Tislelizumab
Description: Administered by intravenous infusion
Arm group label: Part B (Combination Dose Escalation and Safety Expansion)

Summary: 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).

Criteria for eligibility:
Criteria:
Inclusion 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 Exclusion Criteria: 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. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Scri Oncology Partners

Address:
City: Nashville
Zip: 37203
Country: United States

Status: Recruiting

Facility:
Name: The First Affiliated Hospital, Zhejiang University School of Medicine

Address:
City: Hangzhou
Zip: 310003
Country: China

Status: Recruiting

Facility:
Name: Auckland City Hospital

Address:
City: Auckland
Zip: 1023
Country: New Zealand

Status: Recruiting

Start date: July 23, 2024

Completion date: October 30, 2026

Lead sponsor:
Agency: BeiGene
Agency class: Industry

Source: BeiGene

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06427941