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Advanced Solid TumorPhase 1/2NCT05188664

Study of LaNova Medicines(LM)-302 in Combination With Toripalimab in Patients With Advanced Solid Tumors

A Phase 1/2 study testing LM-302 and Toripalimab in people with Advanced Solid Tumor, run by LaNova Australia Pty Limited at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A Phase I/II, Open-Label, Multiple Centre Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of LM- 302 in Combination with Toripalimab in Patients with Advanced Solid Tumors Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
LM-302 and Toripalimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteAustralia
Study dates
10 May 2022to 14 Nov 2023
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 procedure.
  • 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.
  • Subjects must have histological or cytological confirmation of recurrent or refractory advanced solid tumors, and have progressed on standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy.
  • CLDN18.2 test should be performed for the enrolled subjects if the archived tumor tissue samples are available.
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  • At least one measurable lesion for phase II dose expansion, according to RECIST v1.1 as assessed by the investigator.
  • Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose:
  • Bone marrow reserve: Platelet count (PLT) ≥ 90 × 109/L; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; Haemoglobin ≥ 9 g/dL, without receiving EPO, G-CSF, or GM-CSF within 14 days and blood transfusion including red blood cell and platelet transfusion in at least 7 days prior to first dose.
  • Coagulation function: INR ≤ 1.5; APTT ≤ 1.5 × ULN.
  • Liver function: Total bilirubin ≤ 1.5 × ULN (Subjects with Gilbert's Syndrome are allowed if total bilirubin ≤ 3 × ULN); AST and ALT ≤ 2.5 × ULN without liver metastases (≤ 5 × ULN if liver metastases are present); Albumin ≥ 2.5 g/dL.
  • Kidney function: Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min.
  • Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%; QT interval (QTcF) ≤ 480 ms.
  • Subjects who are able to communicate well with investigators and understand and adhere to the requirements of this study.

Who cannot join

  • Participate in any other clinical trial within 28 days prior to 1st dosing of investigational medicinal product (IMP).
  • Subjects with anti-tumor treatment within 21 days prior to 1st dosing of IMP, including radiotherapy, chemotherapy, biotherapy, endocrine therapy and immunotherapy, etc. the following treatments have different time limits:
  • Local small-scale palliative radiotherapy (bone metastasis radiotherapy to control pain) within 14 days prior to 1st dosing.
  • Oral anti-tumor therapy, including fluorouracil antitumor drugs and small molecular targeted drugs, etc. within 14 days or 5 half-lives of the drug (whichever is longer) prior to 1st dosing.
  • Traditional herbal medicine with anti-tumor indication within 14 days prior to 1st dosing.
  • Nitrosourea or Mitomycin C within 42 days prior to 1st dosing.
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  • Subjects who experienced grade 3 or higher hypersensitivity to the treatment that contains monoclonal antibody, e.g., monoclonal antibody therapy, ADC etc.
  • Subjects who were intolerable to the treatment with MMAE based ADCs or anti-CLDN18.2 antibodies, but they can be enrolled if they were tolerable to the treatments and have experienced a 28-day's washout period prior to 1st dosing of IMP.
  • Subjects who were intolerable to the immunotherapy targeting PD-1 receptor, or its ligand PD-L1.
  • Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.
  • Administrate strong inhibitors/strong inducers of CYP3A4 within 14 days prior to 1st dosing of IMP.
  • Subjects who take systemic corticosteroids (> 10 mg daily prednisone equivalents) or other systemic immunosuppressive medications.
  • Pre-existing peripheral sensory or motor neuropathy ≥ Grade 2.
  • Subjects with uncontrolled pain. Subjects requiring analgesic treatment must be on a stable regimen before participating in the study.
  • Subjects with known central nervous system (CNS) or meningeal metastasis.
  • Subjects who have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
  • Subjects with known active keratitis or corneal ulcerations.
  • Use of any live attenuated vaccines within 28 days prior to 1st dosing of IMP.
  • Subjects with the history of idiopathic pulmonary fibrosis, organizing pneumonia.
  • Subjects with the known history of autoimmune disease.
  • Subjects who are taking therapeutic doses of anticoagulants.
  • Subjects with gastric outlet obstruction, persistent recurrent vomiting or uncontrolled/severe gastrointestinal hemorrhage, or ulcer within 28 days prior to 1st dosing of IMP.
  • Subjects who received major surgery or interventional treatment within 28 days prior to 1st dosing of IMP.
  • Subjects who have other active malignancies which are likely to require the treatment.
  • Subjects who have severe cardiovascular disease.
  • Subjects who have uncontrolled or severe illness, including but not limited to ongoing or active infection (e.g., active COVID-19/SARS-CoV-2 infection, etc.) requiring therapeutic antibiotics and/or other administration, while SARS-CoV-2 testing is not mandatory for study entry, and the testing should follow local clinical practice guidelines/standards.
  • Subjects who have a history of immunodeficiency disease, including other acquired or congenital immunodeficiency diseases, or organ transplantation, or allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation.
  • HIV infection, active HBV and HCV infection.
  • Child-bearing potential female who have positive results in pregnancy test or are lactating.
  • Subjects who have psychiatric illness or disorders that may preclude study compliance; Subject who is judged as not eligible to participate in this study by the investigator.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • The Alfred

    Melbourne

Other trials in Australia

About this study

Official title: A Phase I/II, Open-Label, Multiple Centre Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of LM- 302 in Combination With Toripalimab in Patients With Advanced Solid Tumors

A Phase I/II, Open-Label, Multiple Centre Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of LM- 302 in Combination with Toripalimab in Patients with Advanced Solid Tumors

Read the detailed description

This is a study of LM-302 in combination with toripalimab in patients with advanced solid tumors .The study includes phase I (dose escalation) and phase II (dose expansion). All participants enrolled in the study will be administered every 3 weeks (1 cycle=21 days) with a dose of LM-302 intravenous infusion followed by toripalimab intravenous infusion on day 1 until meet the criteria of treatment discontinuation or withdraw, whichever occurs earlier.

Being tested
LM-302, Toripalimab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LM-302Drug

    LM-302 is given by intravenous (IV) infusion on day 1 every 3 weeks。

  • ToripalimabDrug

    Also called Tuoyi

    Toripalimab with a fixed dose is given by intravenous (IV) infusion on day 1 every 3 weeks.

Study groups in NCT05188664
Study groupRoleWhat they receive
LM-302 monotherapy dose escalationExperimentalLM-302 monotherapy dose escalation (part Ia). Accelerated titration combined with traditional 3+3 design will be used for monotherapy dose escalation (part Ia).
Receives: Drug: LM-302
LM-302 in combination therapy dose escalationExperimentalLM-302 in combination therapy dose escalation (part Ib).Accelerated titration combined with traditional 3+3 design will be used for LM-302 in combination with fixed dose Toripalimab dose escalation (part Ib).
Receives: Drug: LM-302; Drug: Toripalimab
LM-302 Dose ExpansionExperimentalSMC will select appropriate dose(s) and/or tumor types for dose expansion study.
Receives: Drug: LM-302; Drug: Toripalimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DLT

    To assess the safety and tolerability for LM-302 in combination with toripalimab in subjects with advanced solid tumors.

    Measured: Cycle 1 of each cohort. Duration of one cycle is 21 days

  2. RP2D

    Obtain the recommended phase 2 dose (RP2D) for LM-302 in combination with toripalimab in subjects with advanced solid tumors.

    Measured: Up to 6 months

  3. OBD

    Obtain the optimal biologic dose (OBD) for LM-302 in combination with toripalimab in subjects with advanced solid tumors.

    Measured: Up to 6 months

  4. MTD

    Obtain the Maximum Tolerated Dose (MTD) for LM-302 in combination with toripalimab in subjects with advanced solid tumors.

    Measured: Up to 21 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2022
  2. Study start10 May 2022
  3. Primary completion14 Nov 2023
  4. Study completion14 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
This study includes two stages, Phase I (Dose escalation) which includes LM-302 monotherapy dose escalation (part Ia) and LM-302 in combination with Toripalimab therapy dose escalation (part Ib) and Phase II (Dose expansion).
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05188664
Sponsor's protocol ID
LM302-01-201
Status last verified
Feb 2025
First submitted
8 Dec 2021
Last updated
17 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing LM-302 and Toripalimab in people with Advanced Solid Tumor, run by LaNova Australia Pty Limited at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLT (time frame: Cycle 1 of each cohort. Duration of one cycle is 21 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05188664.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.

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