LAT010 for Solid Tumors

(LIGHTSPEED-1 Trial)

Recruiting at 1 trial location

Overseen By Lightspeed Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Latticon Antibody Therapeutics, Inc

Must not be taking: Corticosteroids

Disqualifiers: Cardiovascular events, CNS metastases, others

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

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test LAT010, a new treatment for individuals with advanced solid tumors, such as melanoma or lung cancer, where the disease has progressed despite standard treatments. Researchers seek to determine the safety and effectiveness of LAT010 both alone and in combination with another cancer drug (a PD-1 inhibitor) in combating these tumors. The trial seeks participants who have exhausted all standard treatments without success, have tumors measurable by scans, and can manage daily tasks independently. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I need to stop taking my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, you cannot have used another systemic anti-cancer therapy within 3 weeks or 5 half-lives before the first dose of LAT010, whichever is shorter. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that LAT010 is likely to be safe for humans?

Research has shown that LAT010 is being tested in patients with advanced solid tumors. Specific safety information is not yet available, as the trial remains in its early stages. Researchers are still learning about the treatment's safety for people.

Earlier studies of LAT010 have examined how patients respond to the treatment and what side effects might occur. So far, LAT010 is being tested in different doses to determine which is safest and most effective. It is also being developed for other cancers, such as kidney cancer and a type of lung cancer.

Since LAT010 is in the early testing stages, the main goal is to ensure its safety for people. This involves starting with low doses and gradually increasing them while monitoring for any side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for solid tumors?

Unlike the standard treatments for solid tumors, which often include chemotherapy, surgery, and radiation, LAT010 is unique because it targets specific proteins involved in tumor growth. Researchers are excited about LAT010 because it is designed to work alone or in combination with a PD-1 inhibitor, potentially enhancing its effectiveness against tumors that are resistant to current therapies. By focusing on a new mechanism of action, LAT010 aims to provide a more targeted approach to treating solid tumors, potentially improving outcomes and reducing side effects compared to conventional options.

What evidence suggests that LAT010 might be an effective treatment for solid tumors?

Research shows that LAT010 targets a protein called LAT1, linked to cancer growth and spread, making it a promising option for treating solid tumors. This trial studies LAT010 in two phases: Phase 1 involves dose escalation to determine safety and the recommended Phase 2 dose (RP2D), while Phase 2 involves dose expansion to evaluate LAT010 as a monotherapy and in combination with a PD-1 inhibitor. Early results suggest that targeting LAT1 might slow or stop tumor growth. Although LAT010 remains under study, its method relies on a strong understanding of tumor biology. More information is needed to fully assess its effectiveness, but early signs are encouraging. ^{1 2 3 5 6}

Who Is on the Research Team?

John Li, PhD

Principal Investigator

Latticon Antibody Therapeutics, Inc

Are You a Good Fit for This Trial?

This trial is for patients with advanced solid tumors who have not responded to standard treatments. It's a first-in-human study, meaning it's the first time this treatment is being tested in people. Participants must be adults with measurable disease and acceptable organ function.

Inclusion Criteria

Expected life expectancy of >12 weeks per the Investigator.

There is a contraindication for the indicated standard therapies in the opinion of the Investigator.

Patients are willing and able to comply with the protocol-related procedures (including screening evaluations), such as visits, treatment plans, laboratory assessments, and other requirements of the study.

Exclusion Criteria

Other exclusions:

Recent medical concerns exclusions:

I am willing and able to follow the study's requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Dose Escalation

LAT010 monotherapy with ascending doses in patients with locally advanced or metastatic solid tumors. LAT010 will be administered in planned 7 dose cohorts to determine safety and RP2D.

4 weeks per cycle

Weekly visits for IV injection

Phase 2 Cohort Expansion

LAT010 monotherapy at the RP2D and in combination with a PD-1 inhibitor in patients with selected tumor types. Antitumor activity and safety will be further evaluated.

Up to 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 15 months

What Are the Treatments Tested in This Trial?

Interventions

• LAT010

Trial Overview The trial is testing LAT010 alone and in combination with an immune checkpoint inhibitor (ICI) to see how safe they are and how well they work against tumors. The study has two parts: early testing of different doses (Phase 1) followed by expansion to more patients at selected dose levels (Phase 2).

How Is the Trial Designed?

Group I: Phase 2 LAT010 Dose Expansion Experimental Treatment 2 Interventions

LAT010 monotherapy at the RP2D and in combination with a PD-1 inhibitor in patients with selected tumor types. LAT010 will be administered at multiple dose levels based on the results of Phase 1. Antitumor activity and safety will be further evaluated.

Group II: Phase 1 LAT010 Dose Escalation Experimental Treatment 1 Intervention

LAT010 monotherapy with ascending doses in patients with locally advanced or metastatic solid tumors. LAT010 will be administered in planned 7 dose cohorts to determine safety and RP2D. PD profile of LAT010 will also be characterized.

Who Is Running the Clinical Trial?

Latticon Antibody Therapeutics, Inc

Lead Sponsor

Trials

1

Recruited

150+

Published Research Related to This Trial

In a study of 93 cancer patients, LAT1 and CD98 expressions were significantly higher in metastatic tumors compared to primary tumors, suggesting their role in cancer metastasis.

LAT1 expression was closely linked to increased cell proliferation and angiogenesis, indicating that targeting LAT1 could be a potential strategy in managing metastatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

l-type amino acid transporter 1 and CD98 expression in primary and metastatic sites of human neoplasms. Kaira, K., Oriuchi, N., Imai, H., et al.[2017]

LAT1 was found to be overexpressed in various subtypes of HER2 negative breast cancer, indicating its potential as a prognostic marker and a target for therapy, especially since it was present in 83.6% of HER2 negative cases.

Although LAT1 expression did not show significant survival differences in HER2 negative patients, there was a concerning trend where 5 out of 55 patients with LAT1 positive expression died, compared to none in the LAT1 negative group, suggesting a possible link between LAT1 and poorer outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LAT1 (SLC7A5) Overexpression in Negative Her2 Group of Breast Cancer: A Potential Therapy Target. Bodoor, K., Almomani, R., Alqudah, M., et al.[2021]

Inhibition of L-type amino acid transporter 1 (LAT1) using the selective inhibitor nanvuranlat significantly reduced cancer cell proliferation, migration, and invasion in B16-F10 melanoma mouse models, indicating its potential as a target for anti-metastasis therapy.

The study found that LAT1 inhibition downregulated the mTOR signaling pathway and decreased the expression of integrin αvβ3, which is linked to reduced metastasis in various organs, including the lungs and lymph nodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhibition of cancer-type amino acid transporter LAT1 suppresses B16-F10 melanoma metastasis in mouse models. Shi, Z., Kaneda-Nakashima, K., Ohgaki, R., et al.[2023]

The LAT1-specific inhibitor JPH203 shows promise in reducing tumor size and metastasis in colorectal cancer (CRC) by targeting LAT1, which is predominantly expressed in cancerous tissues and associated with tumor progression.

In both in vitro and in vivo studies, JPH203 effectively inhibited tumor growth and affected pathways related to amino acid metabolism and stromal activation, suggesting its potential as a therapeutic agent for CRC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Anti-Tumor Effect of the Newly Developed LAT1 Inhibitor JPH203 in Colorectal Carcinoma, According to a Comprehensive Analysis. Otani, R., Takigawa, H., Yuge, R., et al.[2023]

LAT1 is overexpressed in all types of Non-Hodgkin lymphoma (NHL) and its expression level correlates with lymphoma grade, indicating that higher LAT1 levels are associated with more aggressive forms of the disease.

Inhibiting LAT1 with the specific inhibitor JPH203 effectively reduces lymphoma cell growth, suggesting that targeting LAT1 could be a promising new treatment strategy for NHL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expression of L-type amino acid transporter 1 is a poor prognostic factor for Non-Hodgkin's lymphoma. Jigjidkhorloo, N., Kanekura, K., Matsubayashi, J., et al.[2022]

In a study of 250 breast cancer patients, high expression of the L-type amino acid transporter 1 (LAT1) was linked to more aggressive tumor characteristics and poorer patient outcomes, particularly in ER-positive and HER2-negative cases.

LAT1 expression may serve as a potential therapeutic target in breast cancer, especially for patients with luminal B-like tumors, as it is associated with increased tumor immunoreaction and a higher risk of poor prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of L-type amino acid transporter 1 (LAT1) with the immune system and prognosis in invasive breast cancer. Kurozumi, S., Kaira, K., Matsumoto, H., et al.[2022]

LAT1 is significantly overexpressed in human epithelial ovarian cancers, suggesting it plays a crucial role in the growth and spread of these tumors, as shown in a study of 63 surgical specimens.

Inhibiting LAT1 with BCH effectively reduced the proliferation and migration of ovarian cancer cells (OVCAR-3) and blocked their uptake of l-leucine, indicating that targeting LAT1 could be a promising strategy for developing new cancer therapies that spare normal tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Properties of L-type amino acid transporter 1 in epidermal ovarian cancer. Kaji, M., Kabir-Salmani, M., Anzai, N., et al.[2018]

In a study of 134 patients with bile duct adenocarcinomas, high expression of the L-type amino acid transporter LAT1 was found to be a significant indicator of poor prognosis, suggesting its potential as a prognostic marker.

LAT1 expression, along with surgical margin and pT stage, were identified as independent prognostic factors, indicating that targeting LAT1 could be a promising strategy for new cancer therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High expression of L-type amino acid transporter 1 as a prognostic marker in bile duct adenocarcinomas. Yanagisawa, N., Hana, K., Nakada, N., et al.[2021]

Citations

1. pharmaceutical-technology.com pharmaceutical-technology.com/data-insights/lat-010-latticon-antibody-therapeutics-non-small-cell-lung-cancer-likelihood-of-approval/

LAT-010 by Latticon Antibody Therapeutics for Non-Small ... According to GlobalData, Phase II drugs for Non-Small Cell Lung Cancer have a 38% phase transition success rate (PTSR) indication benchmark for ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06277219

A First-in-Human, Phase 1/2 Study of LAT010 in Patients ... Phase 1 of the study will examine LAT010 in an accelerated and standard "3+3" dose-escalation design. It consists of 7 planned cohorts. Approximately 20 to 50 ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06277219/a-first-in-human-phase-1-2-study-of-lat010-in-patients-with-advanced-solid-tumors-lightspeed-1?state=FL&city=Coconut%20Creek

A First-in-Human, Phase 1/2 Study of LAT010 in Patients ... This is an open-label, multicenter, Phase 1/2, first-in-human (FIH), dose-escalation and cohort-expansion study of LAT010 to evaluate the safety, tolerability, ...

4. withpower.com withpower.com/trial/phase-2-neoplasms-2-2024-58087

LAT010 for Solid Tumors (LIGHTSPEED-1 Trial) What data supports the effectiveness of the drug LAT010 for solid tumors? Research shows that LAT1, a component of LAT010, is linked to cancer growth and spread ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9928633/

Survival Outcomes of Patients With Tropomyosin Receptor ... Pooled data from those studies (data cutoff: July 2020) showed an investigator-assessed objective response rate of 79%, median duration of ...

6. pharmaceutical-technology.com pharmaceutical-technology.com/data-insights/lat-010-latticon-antibody-therapeutics-renal-cell-carcinoma-likelihood-of-approval/

LAT-010 by Latticon Antibody Therapeutics for Renal Cell ... LAT-010 is under clinical development by Latticon Antibody Therapeutics and currently in Phase II for Renal Cell Carcinoma.