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A Phase I/II Study of LM-101 Injection in Patients With Advanced Malignant Tumors

ConditionMalignant Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLaNova Medicines Limited

About this trial

This study is to assess the safety and tolerability, obtain Maximum Tolerated Dose (MTD) and/or the recommended phase 2 dose (RP2D) of LM-101 as a single agent or in combination in patients with advanced malignant tumors

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 years old, male or female.

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

Life expectancy ≥ 3 months.

Disqualifiers

Subject has received prior investigational therapy directed at the same target therapy.

Subjects has participated in any other interventional clinical trial within 21 days prior to the first dosing of LM-101.

Subjects with anti-tumor treatment within 21 days prior to the first dosing of LM-101, 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

Single group

Treatments tested in this trial

  • LM101

    Drug

    Administered intravenously

  • Toripalimab

    Drug

    Administered intravenously

  • Rituximab

    Drug

    Administered intravenously

Treatment groups

139 Participants
are divided into 3 treatment groups
Group A: LM101 Dose EscalationExperimental treatment 1 intervention
Group B: LM101 combination therapy exploratoryExperimental treatment 3 interventions
Group C: LM101 combination expansionExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Incidence of adverse events (AEs)

Phase 1

Time frame
48 weeks
2

Incidence of dose-limitingtoxicity (DLT)

Phase 1

Time frame
48 weeks
3

Incidence of serious adverse event (SAE)

Phase 1

Time frame
48 weeks
4

Temperature in ℃

Phase 1

Time frame
48 weeks

Secondary outcomes

1

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

Phase 1 and 2

Time frame
112 weeks
2

PK Parameter:Time of Maximum Observed Concentration (Tmax)

Phase 1 and 2

Time frame
112 weeks
3

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

Phase 1 and 2

Time frame
112 weeks
4

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

Phase 1 and 2

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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