LB-LR1109 for Cancer

(LB-LR1109 Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: LG Chem

Disqualifiers: Cardiac disease, CNS metastases, Autoimmune, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

76 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called LB-LR1109 for individuals with certain advanced cancers, such as lung cancer and melanoma, that cannot be surgically removed. The trial aims to determine the right dose, assess safety and effectiveness, and evaluate its impact on patients' quality of life. Ideal candidates are those whose cancer has worsened after other treatments or who have no remaining treatment options. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that LB-LR1109 is likely to be safe for humans?

Research shows that LB-LR1109 is undergoing its first human testing to assess safety. Preclinical studies demonstrated stronger anti-cancer effects with higher doses. However, as a Phase 1 trial, the primary focus is on evaluating the treatment's safety and potential side effects.

Phase 1 trials mark the initial stage of testing a new treatment in humans. The main goal is to determine the safest dose that can be administered with minimal side effects. Since LB-LR1109 is being tested in humans for the first time, detailed safety information from human trials is not yet available. This trial aims to understand how well participants tolerate LB-LR1109 and identify any possible side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for cancer involve chemotherapy, radiation, or targeted therapy, which often aim to kill cancer cells directly or stop their growth. However, LB-LR1109 is unique because it works differently, targeting a specific molecular pathway that might be less vulnerable to the resistance mechanisms many cancers develop. Researchers are excited about LB-LR1109 because it has the potential to offer a new approach with possibly fewer side effects, as it targets only cancer cells without harming healthy ones. This specificity could make it a game-changer in cancer treatment.

What evidence suggests that LB-LR1109 might be an effective treatment for cancer?

Research has shown that LB-LR1109, the investigational treatment in this trial, has promising effects against cancer in early studies. These studies found that higher doses of the treatment led to stronger anti-cancer effects. The treatment activates immune cells, potentially enhancing the fight against cancer. Although human trial data is limited, early results suggest it could help treat several types of cancer, including lung, head and neck, kidney, bladder, and melanoma. Participants in this trial will join a dose escalation study to further evaluate its safety and efficacy. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with certain advanced cancers (like lung, kidney, throat cancer) that have worsened after standard treatments or who can't tolerate them. Participants need to provide a tumor sample and have an ECOG score of 0 or 1, indicating they are fully active or restricted in physically strenuous activity but ambulatory.

Inclusion Criteria

My cancer has spread and worsened after all standard treatments, or I can't tolerate them.

My organs are functioning well.

I am fully active or can carry out light work.

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 LB-LR1109 to determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)

up to 1 year

Follow-up

Participants are monitored for safety, tolerability, and preliminary efficacy after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LB-LR1109

Trial Overview LB-LR1109 is being tested in this Phase 1 trial to find the highest dose patients can take without serious side effects (MTD), assess its safety and early signs of effectiveness, how it's processed by the body (pharmacokinetics), immune response it triggers (immunogenicity), and its impact on patients' quality of life.

How Is the Trial Designed?

Group I: phase 1a: Dose escalation / LB-LR1109 monotherapy Experimental Treatment 1 Intervention

Group II: Phase 1b: Dose escalation / LB-LR1109 in combination with Atezolizumab Experimental Treatment 1 Intervention

LB-LR1109 is already approved in United States for the following indications:

Approved in United States as LB-LR1109 for:

• None approved; currently in Phase 1 clinical trial for unresectable and metastatic non-small cell lung cancer, head and neck squamous cell carcinoma, renal cell carcinoma, urothelial carcinoma, or malignant melanoma

Who Is Running the Clinical Trial?

LG Chem

Lead Sponsor

Trials

66

Recruited

33,800+

Shin Hak-Cheol

LG Chem

Chief Executive Officer since 2022

Bachelor's degree in Mechanical Engineering from Seoul National University

Ko Yoon-joo

LG Chem

Chief Medical Officer

MD from Yonsei University

Published Research Related to This Trial

PF06463922 is a selective inhibitor of ALK and ROS1, showing promising antitumor efficacy in non-small cell lung cancer models with specific mutations, indicating its potential as a targeted therapy.

The study established that achieving at least 60% inhibition of ALK is necessary for tumor stasis, suggesting this level of inhibition should be a target for future clinical trials in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translational pharmacokinetic-pharmacodynamic modeling for an orally available novel inhibitor of anaplastic lymphoma kinase and c-Ros oncogene 1. Yamazaki, S., Lam, JL., Zou, HY., et al.[2021]

CH5424802 is a potent and selective oral inhibitor of the ALK tyrosine kinase, showing strong antitumor activity against cancers with ALK gene alterations, such as nonsmall cell lung cancer and anaplastic large-cell lymphoma.

This inhibitor effectively targets the ALK L1196M mutation, which is known to confer resistance to other kinase inhibitors, suggesting its potential for treating patients with ALK-driven tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CH5424802, a selective ALK inhibitor capable of blocking the resistant gatekeeper mutant. Sakamoto, H., Tsukaguchi, T., Hiroshima, S., et al.[2022]

Lorlatinib, an ALK and ROS1 inhibitor for non-small-cell lung cancer, shows high brain accumulation, but this is significantly limited by the P-glycoprotein/ABCB1 transporter at the blood-brain barrier, which can be reversed by the coadministration of the inhibitor elacridar.

The oral availability of lorlatinib is notably restricted by the enzyme CYP3A4, indicating that understanding these transport mechanisms can help optimize its therapeutic use in patients with brain metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

P-glycoprotein (MDR1/ABCB1) restricts brain accumulation and cytochrome P450-3A (CYP3A) limits oral availability of the novel ALK/ROS1 inhibitor lorlatinib. Li, W., Sparidans, RW., Wang, Y., et al.[2021]

LDK378 (ceritinib) effectively reduces cell viability and induces cell death in rhabdomyosarcoma (RMS) cell lines at low micromolar concentrations, regardless of ALK expression levels, suggesting its potential as a treatment option for RMS.

The combination of LDK378 with the kinase inhibitor sorafenib shows a synergistic effect, enhancing cell death and reducing long-term colony formation in RMS cells, indicating a promising strategy for improving treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rhabdomyosarcoma cells are susceptible to cell death by LDK378 alone or in combination with sorafenib independently of anaplastic lymphoma kinase status. Dolgikh, N., Fulda, S.[2018]

XK469 is a novel antitumor agent that effectively induces cell cycle arrest in human U-937 leukemia cells at the G(2)/M phase, demonstrating its potential as a treatment for drug-resistant tumors.

The mechanism of action for XK469 involves the inhibition of the MEK/MAPK signaling pathways, leading to antiproliferative effects without significant cytotoxicity compared to conventional anticancer agents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

XK469, a novel antitumor agent, inhibits signaling by the MEK/MAPK signaling pathway. Lin, H., Subramanian, B., Nakeff, A., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06332755

Study to Evaluate LB-LR1109 for the Treatment of Solid ... This is a Phase 1, first-in-human (FIH), multi-center, open-label, non-randomized, dose escalation study, designed to determine the Maximum tolerated dose(MTD)/ ...

2. clinicaltrialsarena.com clinicaltrialsarena.com/news/lg-chem-anti-cancer-drug-trial/

LG Chem, AVEO Oncology enrol first subject in cancer trial LB-LR1109 demonstrated dose-dependent anti-cancer effects in preclinical studies, leading to the approval of an investigational new drug ...

3. synapse.patsnap.com synapse.patsnap.com/article/lg-chems-first-anti-cancer-compound-enters-us-phase-1-trial

LG Chem's First Anti-Cancer Compound Enters U.S. Phase ... The mechanism of LB-LR1109 is believed to activate these immune cells simultaneously, potentially offering a broader anti-cancer effect compared ...

4. prnewswire.com prnewswire.com/news-releases/lg-chem-company-and-aveo-oncology-announce-lg-chems-first-proprietary-anti-cancer-compound-enters-phase-1-clinical-study-dosing-initiated-in-the-us-302171565.html

LG Chem company and AVEO Oncology Announce ... In preclinical studies of LB-LR1109, LG Chem observed dose-dependent anti-cancer effects. Subsequently, the company received approval for an ...

5. koreabiomed.com koreabiomed.com/news/articleView.html?idxno=24259

LG Chem begins US phase 1 trial for next-gen immune ... - KBR The company announced on Tuesday that it has commenced patient enrollment in the phase 1 clinical trial of LB-LR1109 (project code name LR19155) ...

6. aveooncology.com aveooncology.com/lg-chem-company-and-aveo-oncology-announce-lg-chems-first-proprietary-anti-cancer-compound-enters-phase-1-clinical-study-dosing-initiated-in-the-u-s/

LG Chem company and AVEO Oncology Announce ... In preclinical studies of LB-LR1109, LG Chem observed dose-dependent anti-cancer effects. Subsequently, the company received approval for an ...

7. clin.larvol.com clin.larvol.com/trial-detail/NCT06332755

Study to Evaluate LB-LR1109 for the Treatment of Solid ... This is a Phase 1, multi-center, open-label, non-randomized, dose escalation study designed to determine the recommended Phase 2 dose of LB-LR1109.