Health TrialsbyHealthPanel

A Study of LM-24C5 For Advanced Solid Tumors

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

About this trial

To assess the safety and tolerability, obtain the recommended phase 2 dose (RP2D)/optimal biologic dose (OBD) and/or Maximum Tolerated Dose (MTD) for LM-24C5 in subjects with advanced solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects 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 form (ICF) prior to any study related procedures.

Aged ≥18 years old when sign the ICF, male or female.

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

Participate in any other clinical trial within 28 days prior to 1st dosing of LM-24C5.

Any prior treatments towards the investigational target.

Subjects with anti-tumor treatment within 21 days prior to 1st dosing of LM-24C5, including radiotherapy, chemotherapy, biotherapy, endocrine therapy and immunotherapy, etc. the following treatments have different time limits.

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

  • LM-24C5

    Drug

    Administered intravenously

Treatment groups

49 Participants
are divided into 2 treatment groups
Group A: LM-24C5 Dose EscalationExperimental treatment 1 intervention
Group B: LM-24C5 Dose ExpansionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of adverse events (AEs)

Phase 1

Time frame
60 weeks
2

Incidence of dose-limiting toxicity (DLT)

Phase 1

Time frame
60 weeks
3

Incidence of serious adverse event (SAE)

Phase 1

Time frame
60 weeks
4

Ear Temperature

Phase 1

Time frame
60 weeks

Secondary outcomes

1

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

Phase 1 and 2

Time frame
96 weeks
2

PK Parameter:Time of Maximum Observed Concentration (Tmax)

Phase 1 and 2

Time frame
96 weeks
3

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

Phase 1 and 2

Time frame
96 weeks
4

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

Phase 1 and 2

Time frame
96 weeks

Other outcomes

1

Relationship between the biomarkers and the anti-tumor activity

Phase 1 and 2

Time frame
96 weeks

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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