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
Treatment Effectiveness
Study Objectives
4 Primary · 12 Secondary · Reporting Duration: 126 weeks
126 weeks
Incidence of adverse events (AEs)
Incidence of anti-drug antibodies to LM-108
Incidence of clinical significant in laboratory examinations, including hematology, urinalysis, blood biochemistry, coagulation tests and thyroid function.
Incidence of serious adverse event (SAE)
PK Parameter: Accumulation Ratio (Rac)
PK Parameter: Area Under the Concentration-time Curve (AUC) for LM-108
PK Parameter: Degree of Fluctuation (DF)
PK Parameter: Elimination Half-life (t 1/2)
PK Parameter: Minimum Observed Concentration (Cmin) for LM-108
PK Parameter: Steady State Maximum Concentration (Cmax,ss)
PK Parameter: Steady State Minimum Concentration (Cmin, ss)
PK Parameter: Systemic Clearance at Steady State (CLss)
PK Parameter: Time of Maximum Observed Concentration (Tmax) for LM-108
PK Parameter: Volume of Distribution at Steady-State (Vss)
Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) for LM-108
21 days
Incidence of dose-limiting toxicity (DLT)
Trial Safety
Side Effects for
Treatment (Chemotherapy, NK Infusion, Stem Cell Transplant)
100%Nausea
100%Anemia
100%Fever
100%Lymphocyte count decreased
100%Neutrophil count decreased
100%Platelet count decreased
100%White blood cell decreased
95%Diarrhea
82%Hyperglycemia
77%Fatigue
77%Mucositis oral
64%Sinus tachycardia
59%Anorexia
59%Hypotension
55%Rash maculo-papular
55%Constipation
55%Edema limbs
55%Hypophosphatemia
50%Headache
45%Alanine aminotransferase increased
45%Hypoalbuminemia
45%Hypocalcemia
41%Hypokalemia
41%Dizziness
36%Anxiety
36%Hyponatremia
32%Cough
32%Chills
32%Vomiting
32%Febrile neutropenia
32%Hypertension
32%Insomnia
32%Investigations
27%Alkaline phosphatase increased
27%Aspartate aminotransferase increased
27%Pain
23%Infections and infestations
23%Hiccups
23%Hypomagnesemia
23%Arthralgia
23%Dysphagia
23%Esophagitis
18%Dehydration
18%Hemorrhoids
18%Hypoxia
18%Abdominal pain
18%Allergic rhinitis
18%Dyspnea
18%Generalized muscle weakness
14%Immune system disorders
14%INR increased
14%Infusion related reaction
14%Paresthesia
14%Bloating
14%Dyspepsia
14%Hypermagnesemia
14%Pleural effusion
14%Rectal pain
9%Creatinine increased
9%Arthritis
9%Bone pain
9%Blood bilirubin increased
9%Cholesterol high
9%Flushing
9%Back pain
9%Dry skin
9%Dysgeusia
9%General disorders and administration site conditions
9%Hypernatremia
9%Hyperuricemia
9%Nasal congestion
9%Non-cardiac chest pain
9%Papulopustular rash
9%Renal and urinary disorders
9%Skin ulceration
9%Sore throat
9%Upper respiratory infection
5%Bladder infection
5%Hematuria
5%Weight gain
5%Acute kidney injury
5%Rash acneiform
5%Hemorrhoidal hemorrhage
5%Ileus
5%Vascular disorders
5%Hypoglycemia
5%Neck pain
5%Lung
5%Respiratory failure
5%Atelectasis
5%Atrial fibrillation
5%Ear pain
5%Edema face
5%Encephalopathy
5%Endocrine disorders
5%Epistaxis
5%Eye disorders
5%Flatulence
5%Gastroesophageal reflux disease
5%Gastrointestinal pain
5%Hypercalcemia
5%Hypothyroidism
5%Lung infection
5%Lymph node pain
5%Lymphocyte count increased
5%Metabolism and nutrition disorders
5%Mucosal infection
5%Musculoskeletal and connective tissue disorder
5%Myalgia
5%Nervous system disorders
5%Pain in extremity
5%Peripheral motor neuropathy
5%Prostatic obstruction
5%Pulmonary edema
5%Restlessness
5%Sinus bradycardia
5%Sinusitis
5%Skin and subcutaneous tissue disorder
5%Skin hyperpigmentation
5%Thromboembolic event
5%Tremor
5%Urinary frequency
5%Urinary tract infection
5%Urinary tract pain
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
4 Treatment Groups
LM-108 Dose Escalation
1 of 4
LM-108 Combination Dose Expansion
1 of 4
LM-108 Dose Expansion
1 of 4
LM-108 Combination Dose Escalation
1 of 4
Experimental Treatment
54 Total Participants · 4 Treatment Groups
Primary Treatment: LM-108 · No Placebo Group · Phase 1 & 2
LM-108 Dose Escalation
Drug
Experimental Group · 1 Intervention: LM-108 · Intervention Types: DrugLM-108 Combination Dose ExpansionExperimental Group · 2 Interventions: LM-108, An Anti-PD-1 Antibody · Intervention Types: Drug, Drug
LM-108 Dose Expansion
Drug
Experimental Group · 1 Intervention: LM-108 · Intervention Types: DrugLM-108 Combination Dose EscalationExperimental Group · 2 Interventions: LM-108, An Anti-PD-1 Antibody · Intervention Types: Drug, Drug
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 126 weeks
Who is running the clinical trial?
LaNova Medicines LimitedLead Sponsor
7 Previous Clinical Trials
1,092 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are able to perform daily activities without much difficulty.
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.
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.
Who else is applying?
What state do they live in?
| Georgia | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
Why did patients apply to this trial?
- "I am doing what I can to be better, I can ache at times."
How many prior treatments have patients received?
| 0 | 100.0% |
Frequently Asked Questions
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer