Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Clinical summary
Summary
This is a non-randomised trial with one experimental arm, that has two phases. Phase 1a (dose escalation) has two parts. In Phase 1a, Part A, participants will receive BGB-15025 once daily (orally) as monotherapy in sequential cohorts of approximately 5 increasing doses for up to 6 months. In Phase 1a, Part B, participants will receive BGB-15025 once daily (orally) in sequential cohorts plus 200mg tislelizumab (intravenously) on day 1 of each 21-day cycle for up to 12 months. In Phase 1b (dose expansion) will begin based upon the recommended Phase 2 dose (RP2D) for BGB-15025 (orally) alone or in combination with tislelizumab (intravenously)as determined from Phase 1a.
Conditions
This trial is treating people with advanced solid cancers
Eligibility
Inclusion
- Phase 1a (dose escalation): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom treatment is not available, not tolerated or refused, and who have not received prior therapy targeting HPK1
- Phase 1b (dose expansion): Participant with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors, including non-small cell lung cancer, esophageal cancer or gastric/Gastroesophageal junction cancer (other solid tumors may be included) who have progressed following systemic anticancer therapies or have no prior systemic treatment for advanced disease
- At least 1 measurable lesion as defined per RECIST 1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
- Adequate organ function as indicated by the following laboratory values up to first dose of study treatment: Hemoglobin≥ 90 g/L, Absolute neutrophil count ≥ 1.5 x 109/L , Serum total bilirubin ≤ 1.5 x ULN (< 3 x ULN for participants with Gilbert syndrome ), AST and ALT≤ 2.5 x ULN
Exclusion
- Active leptomeningeal disease or uncontrolled and untreated brain metastasis.
- Active autoimmune diseases or history of autoimmune diseases that may relapse
- Any active malignancy ≤ 2 years before the first dose of study treatment except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent
- 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 treatment
- History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including but not limited to pulmonary fibrosis, acute lung diseases, etc.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body (localised).
- You are able to swallow medication by mouth.
Exclusion
- You have certain types of non-cancer medical conditions.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
BeiGene Australia Pty Ltd
Scientific Title
A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of HPK1 Inhibitor BGB-15025 Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors
Get Support
You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.
Know more about Peer Connect
If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.
Get support
Learn more about clinical trials through this collection of resources in languages other than English.
View information