A Study of LM-168 Combined With Other Anti-tumor Treatments in Participants With Advanced Solid Tumors

NCT07669415 | Recruiting Phase 2

• 1 other identifier: LM168-02-201
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

For Safety introduction phase，this study is to evaluate the safety and tolerability of LM-168 in combination with other anti-tumor treatment regimens in participants of advanced solid tumor trials, determine the maximum tolerated dose (MTD), and explore the recommended phase II dose (RP2D). For Dose expansion phase，this study is to evaluate the preliminary antitumor activity of LM-168 in combination with other antitumor treatment regimens in participants of advanced solid tumor trials, measured by objective response rate (ORR)

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Incidence of dose-limiting toxicity (DLT)

  Safety introduction phase

  78 Weeks

• Objective response rate (ORR)

  Dose expansion phase

  From start of treatment to date of documented disease progression, up to approximately 42 months

Secondary Outcomes (19)

• Duration of response (DoR)

  Time from initial response (CR or PR) to date of documented disease progression or death (due to any cause) whichever occurs first, up to approximately 42 months

• Disease control rate (DCR)

  From start of treatment to date of documented disease progression, up to approximately 42 months

• Progression Free Survival (PFS)

  up to 42 months

• Overall Survival (OS)

  up to 42 months

• AE and SAE

  From signing the ICF until 28 days after EOT or accept other anti-cancer therapy,up to 40 days after last study dose

Study Arms (4)

LM-168 + Tislelizumab Safety introduction

EXPERIMENTAL

Drug: LM-168; Drug: Tislelizumab

LM-168 Dose Expansion

EXPERIMENTAL

Drug: LM-168

LM-168 + Tislelizumab Dose Expansion

EXPERIMENTAL

Drug: LM-168; Drug: Tislelizumab

LM-168 + Tislelizumab +Other anti-tumor treatments Dose Expansion

EXPERIMENTAL

Drug: LM-168; Drug: Tislelizumab; Drug: Docetaxel injection

Interventions

LM-168 DRUG

Q3W,Intravenous Drip

LM-168 + Tislelizumab +Other anti-tumor treatments Dose Expansion; LM-168 + Tislelizumab Dose Expansion; LM-168 + Tislelizumab Safety introduction; LM-168 Dose Expansion

Tislelizumab DRUG

Q3W,Intravenous Drip

LM-168 + Tislelizumab +Other anti-tumor treatments Dose Expansion; LM-168 + Tislelizumab Dose Expansion; LM-168 + Tislelizumab Safety introduction

Docetaxel injection DRUG

Q3W,Intravenous Drip

LM-168 + Tislelizumab +Other anti-tumor treatments Dose Expansion

Eligibility Criteria

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

You may qualify if:

• Participants who are fully informed of the purpose, nature, method and possible adverse reactions of the study, and are willing to participate in the study and sign the informed consent document prior to any procedure.
• Aged ≥18 years old, male or female when sign the Informed consent form (ICF).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, and no deterioration within 2 weeks prior to the first dose.
• Life expectancy ≥ 3 months.
• In dose escalation stage, participants 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, participants must have histological or cytological confirmation of selected advanced solid tumors.
• Pre-treatment archived tumour tissue (within 5 years) or on treatment could be provided for biomarker analysis optionally.
• At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
• Participants must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose.
• Participants who are able to communicate well with investigators and understand and adhere to the requirements of this study

You may not qualify if:

• Received any other investigational product or treatment within 28 days prior to the first dose of LM-168.
• Received anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) agents, any other immunotherapy or oncology immune-oncology (IO) drugs within 28 days prior to the first dose of LM-168; or permanently discontinued prior immunotherapy due to immune-related adverse events (irAEs). All adverse events (AEs) from previous anti-tumor treatments have not fully resolved or resolved to Grade 1 prior to screening. Requirement for additional immunosuppressants (other than low-dose corticosteroids) to control irAEs.
• Received other anti-tumor treatments prior to the first dose of LM-168, as specified below:
• Received limited-field palliative radiotherapy within 14 days prior to the first dose (excluding radiotherapy solely for pain control of bone metastases).
• Received chemotherapy, small-molecule targeted agents (e.g., tyrosine kinase inhibitors) or hormonal therapies within 14 days prior to the first dose or within 5 half-lives of the respective agent (whichever is longer).
• Received biologic therapy or immunotherapy within 28 days prior to the first dose or within 5 half-lives of the respective agent (whichever is shorter).
• Received traditional Chinese medicines with anti-tumor indications within 14 days prior to the first dose.
• Received nitrosoureas or mitomycin C within 42 days prior to the first dose.
• AEs from prior anti-tumor treatments have not recovered to Grade ≤ 1 per NCI CTCAE Version 6.0. Exceptions include: toxicities assessed by the Investigator to pose no safety risks (e.g., alopecia), long-term radiation-related toxicities with Grade ≤ 2, and hypothyroidism stabilized with hormonal replacement therapy.
• Uncontrolled tumor-related pain. Participants requiring analgesic treatment must have been on a stable analgesic dose prior to study entry.
• Known active brain metastases or leptomeningeal metastases.
• Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage.
• Esophageal or gastric varices requiring immediate clinical intervention, or a history of variceal bleeding; except for participants with stable conditions confirmed by endoscopic evaluation within 3 months prior to the first study drug administration.
• History of hepatic encephalopathy, hepatorenal syndrome, or cirrhosis classified as Child-Pugh Class B or higher.
• Tumor invasion into adjacent vital organs (e.g., aorta, heart, pericardium, superior vena cava, trachea, esophagus, etc.), or at risk of developing esophagotracheal fistula or esophagopleural fistula.

Sponsors & Collaborators

• LaNova Medicines Limited: lead

Study Sites (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 201210, China

RECRUITING

MeSH Terms

Interventions

tislelizumab; Docetaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• lin shen

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

wei wang

CONTACT

021-68889618; weiwang@Lanovamed.com

liang kong

CONTACT

021-68889618; Paulkong@lanovamed.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 25, 2026
• Study Start: July 29, 2026
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): December 15, 2028
• Last Updated: July 30, 2026

Record last verified: 2026-07

Locations

CN (1)