Safety and Efficacy of KY1044 and Atezolizumab in Advanced Cancer

  • STATUS
    Recruiting
  • End date
    May 3, 2023
  • participants needed
    412
  • sponsor
    Kymab Limited
Updated on 3 February 2021
cancer
monoclonal antibodies
measurable disease
carcinoma
breast cancer
squamous cell carcinoma
lung cancer
pd-l1
programmed cell death 1 ligand 1
solid tumour
solid neoplasm
squamous cell carcinoma of head and neck
atezolizumab
lung carcinoma

Summary

A Phase 1/2, open label, multi-center study to evaluate the safety, efficacy and tolerability of KY1044 as single agent and in combination with anti-PD-L1 (atezolizumab) in adult patients with selected advanced malignancies, who are ineligible for or there are no available therapies known to confer a clinical benefit for their disease, or they have exhausted all such available options in each indication and therefore will be patients for whom a clinical trial is appropriate.

Details
Condition Pancreatic Cancer, Non-Small Cell Lung Cancer, Cervical Cancer, Adenocarcinoma, Disorders of cervix NOS, Malignant neoplasm of kidney, Uterine Cancer, Pancreatic disorder, Breast Cancer, Esophageal Diseases, Esophageal Cancer, melanoma, Squamous cell carcinoma, Renal Cell Carcinoma, skin cancer, HEPATIC NEOPLASM, Neoplasm of unspecified nature of digestive system, HEPATOCELLULAR CARCINOMA, Gastropathy, Gastric Cancer, head and neck cancer, Diet and Nutrition, Chronic Diarrhea, Stomach Discomfort, Pancreatic Disorders, Skin Wounds, Metastatic Melanoma, Chronic Shoulder Pain, Vaginal Atrophy, Adverse Effects, Drugs, Injection Port, Breast Cancer - HER2 Positive, Anal Dysplasia, Primary Immunodeficiency, Pediatric Health, Near-Sighted Corrective Surgery, Advanced Cancer, Esophageal Carcinoma, Squamous Cell Carcinoma of the Head and Neck, Peripheral Arterial Occlusive Disease, Triple Negative Breast Cancer, Brain Function, Squamous Cell Carcinoma of Head and Neck, Gastric Carcinoma, Recurrent Respiratory Papillomatosis, Razor Bumps (Pseudofolliculitis Barbae), Islet Ce417ll Cancer, Metastatic Triple-Negative Breast Cancer, Kidney Cancer, Esophageal Disorders, Malignant Melanoma, Liver Cancer, Malignant Adenoma, Stomach Cancer, Renal Cell Cancer, Renal Cancer, Digestive System Neoplasms, cervical carcinoma, clear cell renal cell carcinoma, cancer advanced, gastric cancers, esophagus cancer, oesophageal cancer, nsclc, cervical cancer, uterine, cancer of the pancreas, carcinoma of the cervix uteri, carcinoma of the cervix, cervix cancer, cancer of the cervix, carcinoma of cervix, pancreatic cancers, cancer, pancreatic, liver cell carcinoma, cancer of the esophagus, oesophageal carcinoma
Treatment KY1044, KY1044 and atezolizumab
Clinical Study IdentifierNCT03829501
SponsorKymab Limited
Last Modified on3 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: HEPATOCELLULAR CARCINOMA or Cervical Cancer or Advanced Cancer or Pancreatic Cancer or Triple Negative Breast Cancer or Non-Small Cell Lung Cancer or ...?
Do you have any of these conditions: or Stomach Cancer or gastric cancers or cancer advanced or Renal Cancer or Uterine Cancer or Pancreatic Cancer or Razor Bumps (Pseudofolliculitis Bar...?
Do you have any of these conditions: Esophageal Diseases or Non-Small Cell Lung Cancer or cervical carcinoma or Skin Wounds or Esophageal Carcinoma or Malignant Adenoma or Pediatric Healt...?
Age 18 years (20 years in Taiwan)
Histologically documented advanced/metastatic malignancies
Phase 1 and Phase 2 participants with advanced/metastatic malignancies who have measurable disease (non-measurable disease is allowed only in Phase 1) as determined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) will be eligible if, according to the National Comprehensive Cancer Network (NCCN) guidelines, there are no available therapies known to confer a clinical benefit for their disease, or they have exhausted all such available options. Additionally, the following specific tumor indications will be enrolled
Phase 1: Participants with advanced/metastatic malignancies, and preferred indications (non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), hepatocellular carcinoma (HCC), melanoma, cervical, esophageal, gastric, renal, pancreatic, and triple negative breast cancer)
Phase 2 KY1044 single agent: Participants with advanced/metastatic malignancies in indications in which signs of anti-tumor activity (Complete Response (CR), Partial Response (PR) or durable stable disease (SD) with tumor shrinkage that does not qualify for PR) were seen during the dose escalation of KY1044 as single agent
Phase 2 KY1044 in combination with atezolizumab: Participants with advanced/metastatic malignancies in the selected indications below, and/or indications which have shown promising activity in Phase 1
NSCLC (anti-PD-(L)1 therapy nave and pre-treated)
Gastric (anti-PD-(L)1 therapy nave and pre-treated)
HNSCC (anti-PD-(L)1 therapy nave and pre-treated)
Esophageal (anti-PD-(L)1 therapy nave and pre-treated)
Cervical (anti-PD-(L)1 therapy nave and pre-treated)
Indications, in which signs of anti-tumor activity has been observed in Phase 1 with KY1044 in combination with atezolizumab
Prior therapy with anti-PD-(L)1 inhibitors is allowed provided any toxicity attributed to prior anti-PD-(L)1-directed therapy did not lead to discontinuation of therapy
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
Life expectancy longer than 12 weeks
Must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution's guidelines. Participants must be willing to undergo a new tumor biopsy at screening, and during therapy on the study

Exclusion Criteria

Presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require local CNS-directed therapy, or increasing doses of corticosteroids within the prior 2 weeks of first dose of study treatment
History of severe hypersensitivity reactions to other monoclonal antibodies and/or their excipients
Known presence of neutralizing anti-atezolizumab antibodies (for patients previously treated with atezolizumab)
Having out of range laboratory values: creatinine, bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), absolute neutrophil count (ANC), platelet count, hemoglobin
Impaired cardiac function or clinically significant cardiac disease
Known human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection
Malignant disease, other than that being treated in this study
Any medical condition that would, in the Investigator's judgment, prevent participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study results
Active autoimmune disease or a documented history of autoimmune disease
Participants previously exposed to anti-PD-(L)1 treatment who are not adequately treated for skin rash or had no replacement therapy for endocrinopathies should be excluded
Participants with a history of drug-induced pneumonitis or current pneumonitis
Systemic steroid therapy or any immunosuppressive therapy. Topical, inhaled, nasal, and ophthalmic steroids are not prohibited
Use of life attenuated vaccines against infectious diseases within 4 weeks of the first dose of study treatment
Anti-CTLA4, anti-PD-(L)1 treatment within 4 weeks of the first dose of study treatment
Pre-treatment with anti-CTLA4 antibodies in combination with any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathway
Presence of Common Terminology Criteria for Adverse Events version 5 (CTCAE v5) Grade 2 toxicity (except alopecia, peripheral neuropathy and ototoxicity, which are excluded if CTCAE v5 Grade 3) due to prior cancer therapy
Radiotherapy within 2 weeks of the first dose of study treatment, except for palliative radiotherapy to a limited field, such as for the treatment of bone pain or a focally painful tumor mass. To allow evaluation for response to treatment, participants enrolled in the Phase 2 part must have remaining measurable disease that has not been irradiated
Pregnant or lactating women
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