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A Phase I/II Study of LM-2417 in Subjects With Advanced Solid Tumours

ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorLaNova Medicines Limited

About this trial

This study is to assess the safety and tolerability, obtain the recommended phase 2 dose(RP2D)/or Maximum Tolerated Dose (MTD) for LM-2417 as a single agent or in combination with other anti-tumour agents in subjects with advanced solid tumours.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.

Aged 18-80 years old (including boundary values) , male or female.

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Life expectancy ≥ 3 months.

Disqualifiers

Previously received with same target therapy.

Subjects has participated in any other interventional clinical trial within 28 days prior to the first dosing of LM-2417.

Subjects with anti-tumor treatment within 21 days prior to the first dosing of LM-2417, including radiotherapy, chemotherapy, endocrine therapy, and immunotherapy, etc.

Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.

Trial design

Design model

Sequential

Treatments tested in this trial

  • LM-2417

    Drug

    Q2W/Q3W,Intravenous Drip

  • Docetaxel

    Drug

    Q3W,Intravenous Drip

  • Toripalimab/Tirelizumab

    Drug

    Q3W,Intravenous Drip

  • Carboplatin

    Drug

    Q3W,Intravenous Drip

  • Niraparib

    Drug

    QD,Oral Administration

  • Lenvatinib

    Drug

    QD,Oral Administration

Treatment groups

320 Participants
are divided into 3 treatment groups
Group A: LM2417 Dose Escalation(Q2W/Q3W)Experimental treatment 1 intervention
Group B: LM-2417 combination therapy exploratoryExperimental treatment 6 interventions
Group C: LM-2417 combination expansionExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Incidence of adverse events (AEs)

Phase I/II

Time frame
60 weeks
2

Incidence of dose-limitingtoxicity (DLT)

Phase I/II

Time frame
60 weeks
3

Incidence of serious adverse event (SAE)

Phase I/II

Time frame
60 weeks
4

Temperatures

Phase I/II

Time frame
60 weeks

Secondary outcomes

1

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

Phase I/II

Time frame
112 weeks
2

PK Parameter:Time of Maximum Observed Concentration (Tmax)

Phase I/II

Time frame
112 weeks
3

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

Phase I/II

Time frame
112 weeks
4

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

Phase I/II

Time frame
112 weeks

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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