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

ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLaNova Medicines Limited

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 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).

Trial design

Design model

Sequential

Treatments tested in this trial

  • LM-168

    Drug

    Q3W,Intravenous Drip

  • Tislelizumab

    Drug

    Q3W,Intravenous Drip

  • Docetaxel injection

    Drug

    Q3W,Intravenous Drip

Treatment groups

108 Participants
are divided into 4 treatment groups
Group A: LM-168 + Tislelizumab Safety introductionExperimental treatment 2 interventions
Group B: LM-168 Dose ExpansionExperimental treatment 1 intervention
Group C: LM-168 + Tislelizumab Dose ExpansionExperimental treatment 2 interventions
Group D: LM-168 + Tislelizumab +Other anti-tumor treatments Dose ExpansionExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Incidence of dose-limiting toxicity (DLT)

Safety introduction phase

Time frame
78 Weeks
2

Objective response rate (ORR)

Dose expansion phase

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

Secondary outcomes

1

Duration of response (DoR)

Dose expansion phase

Time frame
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
2

Disease control rate (DCR)

Dose expansion phase

Time frame
From start of treatment to date of documented disease progression, up to approximately 42 months
3

Progression Free Survival (PFS)

Dose expansion phase

Time frame
up to 42 months
4

Overall Survival (OS)

Dose expansion phase

Time frame
up to 42 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

LaNova Medicines Limited

Lead sponsor

Source ClinicalTrials.gov
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