LM-24C5 for Advanced Solid Tumors

Recruiting at 5 trial locations

Overseen By Paul Kong

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: LaNova Medicines Limited

Must not be taking: Corticosteroids, Anticoagulants, Immunosuppressives, others

Disqualifiers: CNS metastasis, Autoimmune disease, Severe cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

49 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called LM-24C5 to determine its safety and tolerability for individuals with advanced solid tumors that have recurred or resist standard treatments. Researchers aim to find the optimal dose of LM-24C5 by administering different amounts to two groups. Participants must have advanced solid tumors unresponsive to standard treatments and at least one measurable tumor. As a Phase 1 trial, this research seeks to understand how LM-24C5 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires that you stop any anti-tumor treatments, including radiotherapy, chemotherapy, and immunotherapy, at least 21 days before starting the study drug. If you are taking systemic corticosteroids or immunosuppressive medications, you must stop them at least 2 weeks before starting the trial.

Is there any evidence suggesting that LM-24C5 is likely to be safe for humans?

Research shows that LM-24C5 is being tested for safety in people with advanced solid tumors. Early studies have found that this treatment can trigger a strong immune response against tumors. This suggests it might work well, but it could also cause immune-related side effects.

Currently, LM-24C5 is in the early stages of human testing. Researchers closely monitor how participants handle the treatment and work to determine the right dose. Since it is still under investigation, detailed safety information remains limited. However, its progression from lab studies to human trials indicates promise in earlier tests.

Researchers monitor participants for any unwanted effects, helping them understand the treatment's safety and patient reactions to different doses. While risks exist, these studies are designed to manage and minimize them. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard chemotherapy and radiation treatments for advanced solid tumors, LM-24C5 offers a fresh approach by specifically targeting tumor cells with precision. Researchers are excited about LM-24C5 because it uses a novel mechanism of action that potentially minimizes damage to healthy cells, which could result in fewer side effects. The treatment's dose escalation and expansion phases aim to optimize its effectiveness and safety, holding promise for more personalized cancer therapy.

What evidence suggests that LM-24C5 might be an effective treatment for advanced solid tumors?

Research shows that LM-24C5 may help treat advanced solid tumors. Before human testing, lab and animal studies found that LM-24C5 can activate a strong and lasting immune response against tumors. This means it helps the body's defense system find and fight cancer cells. LM-24C5 also appears to work well with other cancer treatments, possibly enhancing their effectiveness. While research in humans is still ongoing, these early results suggest that LM-24C5 could be a promising option for people with advanced solid tumors. Participants in this trial will join either the LM-24C5 Dose Escalation or Dose Expansion arms to further evaluate its effectiveness and safety. ^{1 2 4 5 6}

Who Is on the Research Team?

Terry Pang

Principal Investigator

LaNova

Are You a Good Fit for This Trial?

This trial is for individuals with advanced solid tumors. Specific eligibility criteria are not provided, but typically participants must have a certain type and stage of cancer, meet health condition requirements, and may need to have tried other treatments first.

Inclusion Criteria

Formalin-fixed paraffin-embedded (FFPE) tumor tissue samples meet the minimum requirements

My advanced cancer has returned or didn't respond to treatment, and standard treatments aren't suitable for me.

My recent tests show my organs and bone marrow are functioning well.

Exclusion Criteria

I haven't had any cancer treatments, including radiation or chemotherapy, in the last 21 days.

My side effects from previous cancer treatments are mild or gone.

I am pregnant or breastfeeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of LM-24C5 to determine the Maximum Tolerated Dose (MTD)

60 weeks

Dose Expansion

Participants receive the recommended phase 2 dose (RP2D) to further assess safety and efficacy

36 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

96 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LM-24C5

Trial Overview The study is testing LM-24C5's safety and how well patients can tolerate it. It aims to find the best dose that causes the fewest side effects in people with advanced solid tumors.

How Is the Trial Designed?

Group I: LM-24C5 Dose Expansion Experimental Treatment 1 Intervention

Group II: LM-24C5 Dose Escalation Experimental Treatment 1 Intervention

LM-24C5 is already approved in United States for the following indications:

Approved in United States as LM-24C5 for:

Who Is Running the Clinical Trial?

LaNova Medicines Limited

Lead Sponsor

Trials

13

Recruited

1,400+

Founded

2019

Headquarters

Shanghai, China

Known For

Cancer Therapies

Top Products

LM-299, LM-302, LM-108

Published Research Related to This Trial

In a randomized phase II trial involving 83 metastatic colorectal cancer patients, both sequences of administering CDDP (cisplatin) before or after 5-FU (5-fluorouracil) showed similar antitumor activity, with response rates of 29% in pretreated patients and 56% in chemotherapy-naive patients.

The study found no significant difference in toxicity profiles or plasma pharmacokinetics based on the sequence of drug administration, suggesting that the timing of CDDP relative to 5-FU does not impact their combined effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

5-fluorouracil administered as a 48-hour chronomodulated infusion in combination with leucovorin and cisplatin: a randomized phase II study in metastatic colorectal cancer. Falcone, A., Allegrini, G., Masi, G., et al.[2017]

The OXA-LV5FU2 chemotherapy regimen demonstrated a high overall response rate of 42.5% in patients with advanced gastric cancer, with a median overall survival of 8 months, indicating its efficacy in treating this condition.

The treatment was associated with mild toxicity, with only 16.3% of patients experiencing severe neutropenia and no severe peripheral neuropathy or treatment-related deaths, suggesting it can be safely administered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Oxaliplatin in combination with LV5FU2 for advanced/metastatic gastric cancer-a multicenter study]. Jin, ML., Chen, Q., Cheng, FQ., et al.[2018]

In a study of 26 heavily pretreated patients with doxorubicin-resistant metastatic breast cancer, infusional 5-fluorouracil (5-FU) combined with low-dose oral leucovorin (LV) achieved a 30% response rate, with partial responses lasting a median of eight months.

The treatment was well-tolerated, with 98% of cycles resulting in minimal or no toxicity, suggesting that this regimen can provide effective palliation with manageable side effects for patients with poor prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weekly continuous infusion of 5-fluorouracil with oral leucovorin in metastatic breast cancer patients with primary resistance to doxorubicin. Nieto, Y., Martín, M., Alonso, JL., et al.[2019]

In a phase II trial involving 44 patients with metastatic colorectal carcinoma, a regimen of weekly oxaliplatin, high-dose infusional 5-FU, and leucovorin showed a favorable tolerability profile with no grade IV toxicity observed, although common side effects included gastrointestinal issues and neurotoxicity.

The treatment resulted in a 23% partial response rate and a median overall survival of 13 months, indicating that this combination therapy is effective and warrants further investigation in larger phase III trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II study of weekly oxaliplatin and high-dose infusional 5-fluorouracil plus leucovorin in pretreated patients with metastatic colorectal cancer. Chiara, S., Nobile, MT., Gozza, A., et al.[2018]

In a phase II study involving 53 patients with metastatic colorectal cancer, the intensified LV5FU2 regimen showed a 37% objective response rate and a median progression-free survival of 7 months, indicating promising efficacy.

Despite administering higher doses of 5-FU, the treatment was well-tolerated, with no deaths due to toxicity and manageable side effects, suggesting a favorable safety profile for further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual 5-FU dose adaptation in metastatic colorectal cancer: results of a phase II study using a bimonthly pharmacokinetically intensified LV5FU2 regimen. Ychou, M., Duffour, J., Kramar, A., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06187402

A Study of LM-24C5 For Advanced Solid Tumors A Phase I/II, First-in-Human (FIH), Open-Label, Multiple Centre Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and ...

2. synapse.patsnap.com synapse.patsnap.com/drug/d65fee07409a4c6d9db8ba0af1d5c062

LM-24C5 - Drug Targets, Indications, Patents ... Efficacy of LM-24C5 in Patients With Advanced Solid Tumors. 100 Clinical Results associated with LM-24C5. Login to view more data. 100 ...

3. pharmaceutical-technology.com pharmaceutical-technology.com/data-insights/lm-24c5-lanova-medicines-solid-tumor-likelihood-of-approval/

LM-24C5 by LaNova Medicines for Solid Tumor LM-24C5 is under development for the treatment of solid tumor, non-small cell lung cancer, gastric cancer, junction cancer and colorectal cancer ...

4. lanovamedicines.com lanovamedicines.com/en/news-center/press-release/81.html

LaNova Medicines Receives CDE Approval to Initiate ... Preclinical studies have demonstrated that LM-24C5 can induce durable anti-tumor immune memory and exhibits synergistic effects when used in ...

5. ancora.ai ancora.ai/fr/details/NCT06187402

A Study of LM-24C5 For Advanced Solid Tumors 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-24.

6. go.drugbank.com go.drugbank.com/conditions/DBCOND0030110

Advanced Solid Tumors (DBCOND0030110) GH21 Capsules for Advanced Solid Tumors: A Study on Safety and Early Results ... A Study of LM-24C5 For Advanced Solid Tumors. LM-24C5. treatment, 1, recruiting.