A Study of LM-168 as a Single Agent or in Combination With Toripalimab in Subjects With Advanced Solid Tumours

NCT06868199 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: LM168-01-101
• Study Type: interventional
• Target: 87
• Locations: 2 countries
• Sites: 6

Brief Summary

For phase I ,this study is to assess the safety and tolerability, obtain the recommended phase 2 dose (RP2D) and/or Maximum Tolerated Dose (MTD) for LM-168 as a single agent or in combination with toripalimab in subjects with advanced solid tumours. For phase II ,this study is to assess the preliminary anti-tumour activity of LM-168 as a single agent or in combination with toripalimab measured by objective response rate (ORR) in subjects with advanced solid tumours.

Conditions

Advanced Solid Tumours

Outcome Measures

Primary Outcomes (22)

• Incidence of adverse events (AEs)

  Phase I

  78 weeks

• Incidence of dose-limitingtoxicity (DLT)

  Phase I

  78 weeks

• Incidence of serious adverse event (SAE)

  Phase I

  78 weeks

• Temperature (Celsius)

  Phase I

  78 weeks

• Pulse in BPM(Beat per Minute)

  Phase I

  78 weeks

• Blood Pressure in mmHg

  Phase I

  78 weeks

• Weight in Kg

  Phase I

  78 weeks

• Height in centimeter

  Phase I

  78 weeks

• Blood Routine examination

  Phase I

  78 weeks

• Urine Routine test

  Phase I

  78 weeks

• Blood biochemistry test

  Phase I

  78 weeks

• Coangulation function test

  Phase I

  78 weeks

• Thyroid function test

  Phase I

  78 weeks

• Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage

  Phase I

  78 weeks

• 12-lead electrocardiogram (ECG) in HR

  Phase I

  78 weeks

• 12-lead electrocardiogram (ECG) in RR

  Phase I

  78 weeks

• 12-lead electrocardiogram (ECG) in PR

  Phase I

  78 weeks

• 12-lead electrocardiogram (ECG) in QRS

  Phase I

  78 weeks

• 12-lead electrocardiogram (ECG) in QT

  Phase I

  78 weeks

• 12-lead electrocardiogram (ECG) in QTcF

  Phase I

  78 weeks

• ECOG(Eastern Cooperative Oncology Group) score

  Phase I

  78 weeks

• Objective Response Rate (ORR)

  Phase II

  From 78th week to 130th week (52 weeks in total)

Secondary Outcomes (28)

• Objective Response Rate (ORR)

  78 weeks

• Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax)

  130 weeks

• PK Parameter:Time of Maximum Observed Concentration (Tmax)

  130 weeks

• PK Parameter: Area Under the Concentration-time Curve(AUC)

  130 weeks

• PK Parameter: Steady State Maximum Concentration(Cmax,ss) PK Parameter: Steady State Maximum Concentration(Cmax,ss)

  130 weeks

Study Arms (4)

LM-168 Dose Escalation

EXPERIMENTAL

Drug: LM-168

LM-168 Dose Expansion

EXPERIMENTAL

Drug: LM-168

LM-168 combination dose escalation

EXPERIMENTAL

Drug: LM-168; Drug: Toripalimab

LM-168 combination dose expansion

EXPERIMENTAL

Drug: LM-168; Drug: Toripalimab

Interventions

LM-168 DRUG

Q3W,Intravenous Drip

LM-168 Dose Escalation; LM-168 Dose Expansion; LM-168 combination dose escalation; LM-168 combination dose expansion

Toripalimab DRUG

Q3W,Intravenous

LM-168 combination dose escalation; LM-168 combination dose expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
• Aged ≥18 years old (including boundary values) , male or female.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Life expectancy ≥ 3 months.
• In dose escalation stage, subjects 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.
• In dose expansion stage, subjects must have histological or cytological confirmation of selected advanced solid tumors.
• Pre-treatment archived tumour tissue or on-treatment tumour biopsy could be provided for biomarker analysis optionally.
• At least one measurable disease.
• Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose.
• Subjects who are able to communicate well with investigators and understand and adhere to the requirements of this study.

You may not qualify if:

• Participate in any other clinical trial within 28 days prior to 1st dosing of LM-168.
• Having received prior anti-CTLA-4 or any other immunotherapy or immune-oncology (IO) agent within 28 days of commencing treatment with LM-168 or experienced a toxicity that led to permanent discontinuation of prior immunotherapy.
• Subjects who have received the anti-tumor treatments within the specified time periods prior to the first dosing of LM-168.
• Any adverse event from prior anti-tumour therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.
• Subjects with uncontrolled tumour-related pain.
• Subjects with known central nervous system (CNS) or meningeal metastasis.
• Subjects who have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
• Subjects with esophageal or gastric varices requiring immediate intervention, or those with a history of variceal bleeding.
• Hepatic encephalopathy, hepatorenal syndrome, Child-Pugh class B or more severe liver cirrhosis.
• Tumor invasion of surrounding vital organs or a risk of developing esophagotracheal fistula or esophagopleural fistula.
• Patients with a history of active or previously confirmed inflammatory bowel disease.
• Subjects who experienced grade 3 or higher hypersensitivity to the treatment that contains monoclonal antibody.
• Subjects who previously experienced grade ≥ 3 immune-related adverse events during immunotherapy, as well as subjects who discontinued prior immunotherapy due to severe or life-threatening immune-related adverse events.
• Subjects who take systemic corticosteroids (\> 10 mg daily prednisone equivalents) or other systemic immunosuppressive medications within 2 weeks prior to the first dosing of LM-168.
• Subjects with the known history of autoimmune disease.

Sponsors & Collaborators

• LaNova Medicines Limited: lead

Study Sites (6)

Macquarie University

Ryde, New South Wales, 2109, Australia

RECRUITING

MUPharm Pty Limited trading as Macquarie University Hospital Parmarcy

Ryde, New South Wales, 2109, Australia

RECRUITING

Cancer Care Wollongong Pty Limited

Wollongong, New South Wales, Australia

RECRUITING

Bayview Health-Investigational Drug Services

Perth, Western Australia, 6009, Australia

RECRUITING

One Clinical Reasearch

Perth, Western Australia, 6009, Australia

RECRUITING

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

NOT YET RECRUITING

MeSH Terms

Interventions

toripalimab

Study Officials

• Sherry Qin

  LaNova Medicines Limited

  STUDY DIRECTOR

Central Study Contacts

Alex Yuan

CONTACT

+8615901815211; alexyuan@lanovamed.com

Paul Kong

CONTACT

+8613564682439; paulkong@lanovamed.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: March 10, 2025
• Study Start: May 6, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (5); CN (1)