APG-1387 : A phase 1, open label, multi-center, dose escalation study of the safety, tolerability, pharmacokinetic and pharmacodynamic properties of intravenously administered APG-1387 in patients with advanced solid tumors and lymphomas

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 | Blood / Myeloma / Lymphoma,Bowel (colorectum),Brain and spinal cord,Breast,Female reproductive organs,Head and neck,Lung,Sarcoma,Skin,Stomach and upper gastrointestinal tract,Urinary systemAnus,Astrocytoma,Basal cell carcinoma,Bile duct,Bladder,Bone,Brain,Brain stem,Breast,Cervix,Chondrosarcoma,Colon,Colorectum,Melanoma (Skin),Cutaneous Squamous Cell Carcinoma (CSCC),Endometrium,Ependymomas,Epithelial,Ewing's Sarcoma,Fallopian tube,Gallbladder,Gastrointestinal stromal tumour (GIST),Gastro-oesophageal junction ,Germ cell and sex cord stromal cell,Germ cell tumour,Glioblastoma (GBM) ,Glioma,Head and neck,Kidney,Leiomyosarcoma,Liposarcoma,Liver,Lung,Lymphoma,Medullablastoma,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,Penis,Peritoneal,Prostate,Rectum,Renal cell carcinoma,Rhabdomyosarcoma,Salivary glands,Sarcoma,Small Cell Lung Cancer,Soft Tissue Sarcoma,Spinal Cord,Squamous cell carcinoma ,Stomach,Synovial Sarcoma,Testis,Throat (hypopharynx),Thyroid,Urinary tract,Urothelial,Uterus,Melanoma (Ocular),Vagina,Voice box (larynx),Vulva,Gastro-oesophageal junction ,Urinary tract

Trial Overview Read MoreRead more

This phase I trial is evaluating an intravenously (in the vein) administered drug (APG-1387) in patients with advanced solid cancers or Lymphoma.
 

This trial is treating multiple types of cancer including advanced solid cancers or Lymphoma.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • 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

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Scientific Title

A phase 1, open label, multi-center, dose escalation study of the safety, tolerability, pharmacokinetic and pharmacodynamic properties of intravenously administered APG-1387 in patients with advanced solid tumors and lymphomas

Commercial Sponsor

Jiangsu Ascentage Pharma Inc

Summary

This study aims to establish the safety and best tolerated dose of a new investigational drug called APG-1387 in participants with advanced cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or more and have been diagnosed with an advanced solid tumour or lymphoma. Study details All participants in this study will be treated with a new investigational drug called APG-1387. This drug blocks tumour growth by promoting cell death (a process called apoptosis) in cancer cells and attempts to stop the cancer cells from spreading further throughout the body. This drug has not previously been tested in humans. APG-1387 has undergone extensive testing in various animal models (including rats and monkeys) and human cancer cell models in the laboratory. APG-1387 will be administered via intravenous (IV) infusion (i.e. directly into the vein) on Days 1, 8 and 15 of study participation. The first group of participants will receive a dose of 0.3 mg of APG-1387, and if tolerated the dose will be increased for subsequent patient groups. Participants will be regularly monitored until they reach their endpoint (disease progression, intolerable toxicity or withdrawal of consent) in order to determine safety, tolerability and preliminary efficacy of treatment. The results from this study will be analysed to see if it is worthwhile for this new drug to be tested in future studies involving larger numbers of cancer participants.

Recruiting Hospitals Read MoreRead more

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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