Study of LM-108 as a Single Agent or in Combination With Pembrolizumab in Subjects With Advanced Solid Tumours

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-26

Study Completion Date

2023-10-06

Brief Summary

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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

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Detailed Description

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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).

Conditions

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Advanced Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LM-108 Dose Escalation

Drug: LM-108 Administered intravenously

Group Type EXPERIMENTAL

LM-108

Intervention Type DRUG

Administered intravenously

LM-108 Dose Expansion

Drug: LM-108 Administered intravenously

Group Type EXPERIMENTAL

LM-108

Intervention Type DRUG

Administered intravenously

LM-108 Combination Dose Escalation

Drug: LM-108 Administered intravenously Drug: An Anti-PD-1 Antibody Administered intravenously

Group Type EXPERIMENTAL

LM-108

Intervention Type DRUG

Administered intravenously

An Anti-PD-1 Antibody

Intervention Type DRUG

Administered intravenously

LM-108 Combination Dose Expansion

Drug: LM-108 Administered intravenously Drug: An Anti-PD-1 Antibody Administered intravenously

Group Type EXPERIMENTAL

LM-108

Intervention Type DRUG

Administered intravenously

An Anti-PD-1 Antibody

Intervention Type DRUG

Administered intravenously

Interventions

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LM-108

Administered intravenously

Intervention Type DRUG

An Anti-PD-1 Antibody

Administered intravenously

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
2. 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.
3. At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
4. Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose

Exclusion Criteria

1. Any adverse event from prior anti-tumour therapy has not yet recovered to ≤grade 1 of CTCAE v5.0
2. Uncontrolled tumour-related pain
3. Known central nervous system (CNS)
4. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
5. Use of inhaled corticosteroids
6. Known history of autoimmune disease
7. Use of any live attenuated vaccines within 28 days
8. Have severe cardiovascular disease
9. Uncontrolled or severe illness
10. History of immunodeficiency disease
11. Active malignancies which are likely to require the treatment.
12. Child-bearing potential female
13. Have psychiatric illness or disorders

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No