A Phase I/II, Open-Label, Dose Escalation and Expansion Study of LM-108 as a Single Agent or in Combination With Pembrolizumab in Advanced Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- LM-108
- Conditions
- Advanced Solid Tumor
- Sponsor
- LaNova Medicines Limited
- Enrollment
- 24
- Locations
- 6
- Primary Endpoint
- DLT
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
A Phase I/II, Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LM-108 as a Single Agent or in Combination with Pembrolizumab in Advanced Solid Tumors
Detailed Description
A Phase I/II, Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LM-108 as a Single Agent or in Combination with Pembrolizumab in Advanced Solid Tumors The study schedule includes screening visit (28 days prior to accept the investigational medicinal product (IMP)), treatment visit (accept IMP for the first time to the end of treatment (EOT)/early withdrawal), and follow-up visit (28 days after the EOT/early withdrawal).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •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.
- •At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.
- •Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose
Exclusion Criteria
- •Any adverse event from prior anti-tumour therapy has not yet recovered to ≤grade 1 of CTCAE v5.0
- •Uncontrolled tumour-related pain
- •Known central nervous system (CNS)
- •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- •Use of inhaled corticosteroids
- •Known history of autoimmune disease
- •Use of any live attenuated vaccines within 28 days
- •Have severe cardiovascular disease
- •Uncontrolled or severe illness
- •History of immunodeficiency disease
Arms & Interventions
LM-108 Dose Escalation
Drug: LM-108 Administered intravenously
Intervention: LM-108
LM-108 Dose Expansion
Drug: LM-108 Administered intravenously
Intervention: LM-108
LM-108 Combination Dose Escalation
Drug: LM-108 Administered intravenously Drug: An Anti-PD-1 Antibody Administered intravenously
Intervention: LM-108
LM-108 Combination Dose Escalation
Drug: LM-108 Administered intravenously Drug: An Anti-PD-1 Antibody Administered intravenously
Intervention: An Anti-PD-1 Antibody
LM-108 Combination Dose Expansion
Drug: LM-108 Administered intravenously Drug: An Anti-PD-1 Antibody Administered intravenously
Intervention: LM-108
LM-108 Combination Dose Expansion
Drug: LM-108 Administered intravenously Drug: An Anti-PD-1 Antibody Administered intravenously
Intervention: An Anti-PD-1 Antibody
Outcomes
Primary Outcomes
DLT
Time Frame: 21 days
Incidence of dose-limiting toxicity (DLT)
SAE
Time Frame: 126 weeks
Incidence of serious adverse event
AEs
Time Frame: 126 weeks
Incidence of adverse events
Incidence of clinical significant in laboratory examinations
Time Frame: 126 weeks
Incidence of clinical significant in laboratory examinations, including hematology, urinalysis, blood biochemistry, coagulation tests and thyroid function.
Secondary Outcomes
- Cmax(126 weeks)
- Vss(126 weeks)
- Tmax(126 weeks)
- AUC(126 weeks)
- Rac(126 weeks)
- Incidence of anti-drug antibodies to LM-108(126 weeks)
- Cmin(126 weeks)
- Cmax,ss(126 weeks)
- Cmin, ss(126 weeks)
- CLss(126 weeks)
- t 1/2(126 weeks)
- DF(126 weeks)