Your session is about to expire
← Back to Search
Monoclonal Antibodies
LM-108 for Solid Tumors
Phase 1 & 2
Waitlist Available
Research Sponsored by LaNova Medicines Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histological or cytological confirmation of recurrent or refractory advanced solid tumours, and have progressed on standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 126 weeks
Awards & highlights
Study Summary
This trial is testing a new cancer drug, LM-108, to see if it is safe and effective. The trial will involve patients with advanced solid tumors.
Eligible Conditions
- Advanced Solid Tumors
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have a type of cancer that has come back or is not responding to standard treatments. Your doctor has confirmed this through a biopsy or other testing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 126 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~126 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
AEs
DLT
Incidence of clinical significant in laboratory examinations
+1 moreSecondary outcome measures
AUC
CLss
Cmax
+9 moreSide effects data
From 2021 Phase 2 trial • 22 Patients • NCT03019640100%
Lymphocyte count decreased
100%
White blood cell decreased
100%
Nausea
100%
Fever
100%
Platelet count decreased
100%
Anemia
100%
Neutrophil count decreased
95%
Diarrhea
82%
Hyperglycemia
77%
Mucositis oral
77%
Fatigue
64%
Sinus tachycardia
59%
Hypotension
59%
Anorexia
55%
Hypophosphatemia
55%
Constipation
55%
Edema limbs
55%
Rash maculo-papular
50%
Headache
45%
Hypoalbuminemia
45%
Hypocalcemia
45%
Alanine aminotransferase increased
41%
Hypokalemia
41%
Dizziness
36%
Hyponatremia
36%
Anxiety
32%
Investigations
32%
Insomnia
32%
Vomiting
32%
Chills
32%
Cough
32%
Febrile neutropenia
32%
Hypertension
27%
Pain
27%
Alkaline phosphatase increased
27%
Aspartate aminotransferase increased
23%
Hypomagnesemia
23%
Infections and infestations
23%
Dysphagia
23%
Arthralgia
23%
Esophagitis
23%
Hiccups
18%
Dehydration
18%
Hypoxia
18%
Abdominal pain
18%
Allergic rhinitis
18%
Dyspnea
18%
Generalized muscle weakness
18%
Hemorrhoids
14%
Infusion related reaction
14%
INR increased
14%
Immune system disorders
14%
Bloating
14%
Paresthesia
14%
Pleural effusion
14%
Dyspepsia
14%
Hypermagnesemia
14%
Rectal pain
9%
Upper respiratory infection
9%
Sore throat
9%
Blood bilirubin increased
9%
Bone pain
9%
Cholesterol high
9%
Creatinine increased
9%
Nasal congestion
9%
Papulopustular rash
9%
Arthritis
9%
Back pain
9%
Dry skin
9%
Dysgeusia
9%
Flushing
9%
General disorders and administration site conditions
9%
Hypernatremia
9%
Hyperuricemia
9%
Non-cardiac chest pain
9%
Renal and urinary disorders
9%
Skin ulceration
5%
Hypoglycemia
5%
Lymph node pain
5%
Tremor
5%
Hypothyroidism
5%
Lung infection
5%
Thromboembolic event
5%
Urinary tract pain
5%
Vascular disorders
5%
Weight gain
5%
Lymphocyte count increased
5%
Myalgia
5%
Urinary tract infection
5%
Urinary frequency
5%
Lung
5%
Eye disorders
5%
Gastroesophageal reflux disease
5%
Mucosal infection
5%
Metabolism and nutrition disorders
5%
Musculoskeletal and connective tissue disorder
5%
Peripheral motor neuropathy
5%
Prostatic obstruction
5%
Pulmonary edema
5%
Rash acneiform
5%
Respiratory failure
5%
Acute kidney injury
5%
Ear pain
5%
Edema face
5%
Encephalopathy
5%
Endocrine disorders
5%
Atelectasis
5%
Atrial fibrillation
5%
Bladder infection
5%
Epistaxis
5%
Flatulence
5%
Gastrointestinal pain
5%
Hematuria
5%
Hemorrhoidal hemorrhage
5%
Hypercalcemia
5%
Neck pain
5%
Nervous system disorders
5%
Pain in extremity
5%
Restlessness
5%
Sinus bradycardia
5%
Sinusitis
5%
Skin and subcutaneous tissue disorder
5%
Skin hyperpigmentation
5%
Ileus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Chemotherapy, NK Infusion, Stem Cell Transplant)
Trial Design
4Treatment groups
Experimental Treatment
Group I: LM-108 Dose ExpansionExperimental Treatment1 Intervention
Drug: LM-108 Administered intravenously
Group II: LM-108 Dose EscalationExperimental Treatment1 Intervention
Drug: LM-108 Administered intravenously
Group III: LM-108 Combination Dose ExpansionExperimental Treatment2 Interventions
Drug: LM-108 Administered intravenously Drug: An Anti-PD-1 Antibody Administered intravenously
Group IV: LM-108 Combination Dose EscalationExperimental Treatment2 Interventions
Drug: LM-108 Administered intravenously Drug: An Anti-PD-1 Antibody Administered intravenously
Find a Location
Who is running the clinical trial?
LaNova Medicines LimitedLead Sponsor
8 Previous Clinical Trials
673 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received any live vaccines within the past 28 days.You have a mental health condition or disorder.You have another type of cancer that is currently being treated and may require ongoing treatment.You have a history of a weakened immune system.You currently use inhalers for asthma or other respiratory conditions.You have severe, uncontrolled pain from your tumor.You have a serious heart or blood vessel condition.You have fluid buildup around your lungs, heart, or abdomen that needs to be drained regularly and is not under control.You have a history of an autoimmune disease.You are able to perform daily activities without much difficulty.Any side effects from previous cancer treatment have not fully resolved or are still causing mild symptoms.You must have at least one visible tumor that can be measured using specific guidelines (RECIST v1.1).Your organs and bone marrow must be functioning properly based on recent lab tests taken within a week before starting the study.You have a known condition where the central nervous system (brain and spinal cord) is affected.You have a type of cancer that has come back or is not responding to standard treatments. Your doctor has confirmed this through a biopsy or other testing.
Research Study Groups:
This trial has the following groups:- Group 1: LM-108 Dose Escalation
- Group 2: LM-108 Combination Dose Escalation
- Group 3: LM-108 Combination Dose Expansion
- Group 4: LM-108 Dose Expansion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Solid Tumors Patient Testimony for trial: Trial Name: NCT05255484 — Phase 1 & 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial enrolling participants at present?
"Affirmative. Clinicaltrials.gov shows that this study is actively inviting participants, having been posted on May 26th 2022 and most recently edited on the 29th of the same month. This trial requires 54 test subjects to be recruited from 6 different sites."
Answered by AI
How many facilities are actively administering this experiment?
"This clinical trial is recruiting from 6 different locations; three of which are Cincinnati, Dallas and Indianapolis. To minimize the amount of travel required to partake in this study, it may be wise to select a site closest to you."
Answered by AI
How many applicants are being accepted for inclusion in this experiment?
"54 qualified patients are necessary for the successful completion of this research, which is being carried out by LaNova Medicines Limited across multiple sites such as The Christ Hospital in Cincinnati and Mary Crowley Cancer Research in Dallas."
Answered by AI
Who else is applying?
What state do they live in?
Georgia
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I am doing what I can to be better, I can ache at times.
PatientReceived no prior treatments
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger