NCT04649385 : 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

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18+Age Over 18

Advanced CancersCancer LocationMulti-Cancer
Trial

Systemic therapy,Treatment | Blood / Myeloma / Lymphoma,Bowel (colorectum),Brain and spinal cord,Breast,CUP,Female reproductive organs,Head and neck,Lung,Sarcoma,Skin,Stomach and upper gastrointestinal tract,Urinary systemAcute Lymphoblastic Lymphoma,Adrenocortical carcinoma,Anus,Astrocytoma,Basal cell carcinoma,B-Cell Non Hodgkin Lymphoma,Bile duct,Bladder,Bone,Brain,Brain stem,Breast,Cancer of Unknown Primary,Central Nervous System,Cervix,Chondrosarcoma,Colon,Colorectum,Cutaneous Squamous Cell Carcinoma (CSCC),Diffuse Large Cell Lymphoma,Endometrium,Ependymomas,Epithelial,Ewing's Sarcoma,Fallopian tube,Follicular Lymphoma,Gallbladder,Gastrointestinal stromal tumour (GIST),Gastrointestinal stromal tumors (GISTs),Gastro-oesophageal junction ,Germ cell and sex cord stromal cell,Germ cell tumour,Glioblastoma (GBM) ,Glioma,Head and neck,Hodgkin's Disease (Hodgkin's Lymphoma),Kidney,Langerhans Cell Histiocytosis,Leiomyosarcoma,Liposarcoma,Liver,Lung,Lymphoma,Mantle Cell Lymphoma,Medullablastoma,Melanoma (Ocular),Melanoma (Skin),Meningioma,Merkel cell,Mesothelioma,Mouth (including tonsil, tongue, soft palate, cheeks, lips, gum),Neuroblastoma,Neuroendocrine tumours,Non-Small Cell Lung Cancer,Nose (nasopharynx),Oesophagus,Oral cavity,Oropharynx,Osteosarcoma,Ovary,Pancreas,Paroxysmal Nocturnal Hemoglobinuria (PNH),Penis,Peritoneal,Prostate,Rectum,Renal cell carcinoma,Rhabdomyosarcoma,Salivary glands,Sarcoma,Skin Lymphoma,Small Cell Lung Cancer,Soft Tissue Sarcoma,Spinal Cord,Squamous cell carcinoma ,Stomach,Synovial Sarcoma,T-Cell Lymphoma,Testis,Throat (hypopharynx),Thyroid,Urinary tract,Urothelial,Uterus,Vagina,Voice box (larynx),Vulva,Wilm's tumour

Trial Overview Read MoreRead more

This Phase I trial is trying to understand how safe and tolerable a targeted therapy (BGB-15025) alone and in combination with another targeted therapy (tislelizumab) in people with advanced solid cancers.
 

This trial is treating patients with advanced solid cancers.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

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

Commercial Sponsor

BeiGene Australia Pty Ltd

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.

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Enquiries Line Coordinator
clinicaltrials.enquiries@petermac.org
03 8559 7456 (9am-2pm, Mon-Fri)

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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