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NCT06422520 | RECRUITING | Advanced Solid Tumor

A First-in-Human Study of BGB-C354 Alone and in Combination With Tislelizumab in Participants With Advanced Solid Tumors
Sponsor:

Beigene

Brief Summary:

This is a first-in-human, Phase 1a/1b study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of BGB-C354 alone and in combination with tislelizumab in participants with advanced solid tumors. Study details include: * The study will be conducted in 2 phases: Phase 1a (Monotherapy Dose Escalation and Safety Expansion) and Phase 1b (Dose Expansion). * The visit frequency will be approximately every 21 days during study treatment. * The study duration is estimated to be approximately 5 years.

Condition or disease

Advanced Solid Tumor

Intervention/treatment

BGB-C354

Tislelizumab

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 62 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of BGB-C354, an Antibody-Drug Conjugate Targeting B7H3, Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors
Actual Study Start Date : 2024-07-05
Estimated Primary Completion Date : 2026-11-30
Estimated Study Completion Date : 2026-11-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.
  • 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • 3. Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors, whose cancer is not amenable to therapy with curative intent:
  • 4. ≥ 1 measurable lesion per RECIST v1.1.
  • 5. Able to provide an archived tumor tissue sample.
  • 6. Adequate organ function.
  • 7. Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and for ≥ 7 months after the last dose of study drug(s).
  • 8. Nonsterile males must be willing to use a highly effective method of birth control for the duration of the study treatment period and for ≥ 4 months after the last dose of study drug(s).
Exclusion Criteria
  • 1. Prior treatment with B7H3-targeted therapy.
  • 2. For Part B and Phase 1b: Prior treatment with antibody drug conjugates (ADCs) with topoisomerase I inhibitor payload (for Phase 1b, unless otherwise specified for specific cohorts).
  • 3. Participants with spinal cord compressions, active leptomeningeal disease or uncontrolled, or untreated brain metastasis
  • 4. Any malignancy ≤ 2 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).
  • 5. History of interstitial lung disease, ≥ Grade 2 noninfectious pneumonitis, oxygen saturation at rest \< 92%, or requirement for supplemental oxygen at baseline
  • 6. Uncontrolled diabetes, or \> Grade 1 laboratory test abnormalities in potassium, sodium, or corrected calcium levels despite standard medical management ≤ 14 days before the first dose of study drug(s).
  • 7. Infection (including tuberculosis infection) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study treatment(s).
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A First-in-Human Study of BGB-C354 Alone and in Combination With Tislelizumab in Participants With Advanced Solid Tumors

Location Details

NCT06422520

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Florida

Florida Cancer Specialist Research Institute Lake Nona

Orlando, Florida, United States, 32827-7400

RECRUITING

United States, Massachusetts

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215-5418

RECRUITING

United States, Missouri

Washington University School of Medicine

Saint Louis, Missouri, United States, 63110-1010

RECRUITING

United States, Texas

The University of Texas Md Anderson Cancer Center

Houston, Texas, United States, 77030-4009

RECRUITING

United States, Texas

Next Oncology

San Antonio, Texas, United States, 78229-6028

RECRUITING

Australia, New South Wales

Westmead Hospital

Westmead, New South Wales, Australia, 2145

RECRUITING

Australia, Victoria

St Vincents Hospital Melbourne

Fitzra, Victoria, Australia, 3065

RECRUITING

Australia, Victoria

The Alfred Hospital

Melbourne, Victoria, Australia, 3004

RECRUITING

Australia, Western Australia

One Clinical Research

Nedlands, Western Australia, Australia, 6009

RECRUITING

China, Beijing

Beijing Cancer Hospital

Beijing, Beijing, China, 100142

RECRUITING

China, Guangxi

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China, 530021

RECRUITING

China, Hubei

Hubei Cancer Hospital

Wuhan, Hubei, China, 430079

RECRUITING

China, Jilin

Jilin Cancer Hospital

Changchun, Jilin, China, 130021

RECRUITING

China, Liaoning

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, China, 110042

RECRUITING

China, Sichuan

West China Hospital, Sichuan University

Chengdu, Sichuan, China, 610041