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?

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.

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.

What data supports the effectiveness of the drug LM-24C5 for advanced solid tumors?

The research shows that similar treatments involving 5-fluorouracil (5-FU) and leucovorin (LV) have been effective in treating various types of advanced cancers, such as colorectal and breast cancer, with some patients experiencing significant tumor shrinkage and manageable side effects. ^{1 2 3 4 5}

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

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 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]

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 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]

Citations

1. China pubmed.ncbi.nlm.nih.gov

[Oxaliplatin in combination with LV5FU2 for advanced/metastatic gastric cancer-a multicenter study]. [2018]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Weekly continuous infusion of 5-fluorouracil with oral leucovorin in metastatic breast cancer patients with primary resistance to doxorubicin. [2019]

3. Germany 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. [2022]

4. Greece 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. [2018]

5. Switzerland 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. [2017]