What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as chemotherapy, targeted therapy, and immunotherapy, have a range of side effects. Chemotherapy often causes myelosuppression, leading to anemia, neutropenia, and thrombocytopenia, as well as gastrointestinal issues like nausea, vomiting, and diarrhea. Targeted therapies can result in specific toxicities depending on the target, such as hypertension, skin rashes, and liver toxicity. Immunotherapy, including checkpoint inhibitors, may cause immune-related adverse events like colitis, pneumonitis, and thyroid dysfunction. Novel therapeutic agents like LB101, which target cancer cells, may have unique side effects that are still being studied, but they could potentially include similar toxicities as well as off-target effects.

What prior FDA approvals exist?

The FDA has approved several immunotherapies and targeted therapies for the treatment of solid tumors. Notable approvals include pembrolizumab (Keytruda) and nivolumab (Opdivo), both of which are PD-1 inhibitors used in various cancers such as melanoma, non-small cell lung cancer (NSCLC), and renal cell carcinoma. Atezolizumab (Tecentriq), a PD-L1 inhibitor, has also been approved for similar indications. Additionally, targeted therapies like bevacizumab (Avastin), which inhibits angiogenesis, and various tyrosine kinase inhibitors (TKIs) have been approved for treating specific solid tumors. These therapies work by targeting specific pathways or proteins involved in cancer cell growth and survival.

What other types of research exist?

Promising novel alternatives to LB101 for solid tumor patients in 2024 include: 1) Pembrolizumab, which has shown efficacy in various solid tumors including sarcomas and renal cell carcinoma. 2) Abemaciclib, a CDK4 inhibitor, particularly for dedifferentiated liposarcoma. 3) Axitinib plus pembrolizumab, which has shown activity in advanced sarcomas. 4) Nivolumab, alone or in combination with ipilimumab, for metastatic sarcoma. These agents have demonstrated clinical activity in recent trials and represent potential alternatives for solid tumor treatment.

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LB101 for Solid Tumors

Phase 1 & 2

Recruiting

Research Sponsored by Centessa Pharmaceuticals (UK) Limited

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days following the first dose of lb101 (days 1 to 28 of cycle 1)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment called LB101 on its own in patients with advanced solid tumors. The goal is to see if LB101 is safe, can be tolerated by patients, and if it helps in controlling or shrinking the tumors. The study will also look at how the body processes the treatment and the immune response to it. New studies are looking into different types of treatments for various cancers. Previous concerns about safety had slowed progress, but recent research suggests that new versions of these treatments may be safer and more effective when used with other therapies.

Who is the study for?

Adults (18+) with advanced solid tumors, including specific types of lung, head and neck, cervical, ovarian cancers. Must have tried checkpoint inhibitors previously or have no standard treatment options left. Participants need to be in relatively good health with a life expectancy of at least 12 weeks and weigh over 40 kg. They must agree to use two effective contraception methods if applicable and provide tissue samples.

What is being tested?

The trial is testing LB101 as a solo treatment for various advanced solid tumors to see how safe it is and if it works. It involves people who've already had certain treatments like immune checkpoint inhibitors or those without other treatment choices.

What are the potential side effects?

Specific side effects are not listed but generally could include typical reactions to cancer therapies such as fatigue, nausea, allergic reactions, potential organ inflammation due to immune response, and possibly unique side effects related to LB101's mechanism of action.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days following the first dose of lb101 (days 1 to 28 of cycle 1)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days following the first dose of lb101 (days 1 to 28 of cycle 1)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days following the first dose of lb101 (days 1 to 28 of cycle 1) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part 1: Number of Participants with Recommended Dose(s) for Expansion

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: LB101Experimental Treatment1 Intervention

Part 1 Part 1a participants will receive LB101 once every 2 weeks (Q2W) (28-day cycle), with a preliminary plan for 6 sequential dose levels. Part 1b will be a dose optimization and will include \>1 dose levels and/or dose schedules that have been deemed safe and tolerable in Part 1a. Part 2 Dose regimen(s) for participants in Part 2 will be based on the results of Part 1.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for solid tumors include chemotherapy, targeted therapy, immunotherapy, and radiation. Chemotherapy kills rapidly dividing cells, including cancer cells, but also affects normal cells, leading to side effects. Targeted therapy focuses on specific molecular targets associated with cancer, such as proteins or genes, and tends to have fewer side effects. Immunotherapy boosts the body's immune system to recognize and destroy cancer cells. Radiation therapy uses high-energy particles to damage the DNA of cancer cells, leading to cell death. Understanding these mechanisms helps in selecting the most appropriate treatment based on the tumor's characteristics and the patient's overall health.