What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as immune checkpoint inhibitors (e.g., anti-PD-1/PD-L1 therapies) and targeted therapies, often exhibit side effects including fatigue, rash, diarrhea, and pruritus. More severe adverse events can include pneumonitis, colitis, hepatitis, and endocrinopathies. Targeted therapies may also cause specific toxicities related to their targets, such as hypertension, hand-foot syndrome, and cardiac issues. It is crucial for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

Several FDA-approved treatments for solid tumors exhibit anti-tumor activity and novel mechanisms. For instance, Pembrolizumab and Atezolizumab are immune checkpoint inhibitors that target PD-1 and PD-L1 pathways, respectively, and have been approved for various solid tumors including non-small cell lung cancer and renal cell carcinoma. Enasidenib, approved for relapsed or refractory acute myeloid leukemia with an IDH2 mutation, represents another example of a targeted therapy with a novel mechanism. These treatments, like BGB-A3055, aim to enhance the body's immune response against cancer cells or target specific genetic mutations within tumors.

What other types of research exist?

Promising novel alternatives to BGB-A3055 for solid tumors include: 1) Pembrolizumab (KEYNOTE trials) - an immune checkpoint inhibitor showing efficacy in various solid tumors. 2) Atezolizumab (IMpower trials) - another immune checkpoint inhibitor used in combination with chemotherapy. 3) Cabozantinib - a tyrosine kinase inhibitor with activity in medullary thyroid cancer and renal cell carcinoma. 4) Infigratinib - an FGFR-selective tyrosine kinase inhibitor for cholangiocarcinoma. 5) Futibatinib - another FGFR inhibitor recently approved for cholangiocarcinoma. These alternatives have shown significant anti-tumor activity and are being actively studied in clinical trials.

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Monoclonal Antibodies

BGB-A3055 + Tislelizumab for Cancer

Phase 1

Recruiting

Research Sponsored by BeiGene

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 up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called BGB-A3055, alone or with Tislelizumab, in patients with advanced or metastatic solid tumors. The drugs are given through an IV to see if they can shrink tumors and to find the safest dose that patients can handle.

Who is the study for?

This trial is for adults with advanced or metastatic solid tumors who have tried all standard treatments or can't tolerate them, and haven't been treated for CCR8 before. They must be relatively healthy (ECOG ≤1), have measurable disease, provide tumor tissue samples, and not have had any other cancer in the last 3 years except the one being studied.

What is being tested?

The study tests BGB-A3055's safety and effectiveness alone or with Tislelizumab against advanced solid tumors. It looks at how well these drugs work together to fight cancer and what side effects they might cause.

What are the potential side effects?

Possible side effects include reactions related to the immune system such as inflammation of organs, fatigue, digestive issues like nausea or diarrhea, skin problems like rash, potential lung issues like pneumonitis, and an increased risk of infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Phase 1a: Maximum tolerated dose (MTD) or maximum administered dose (MAD) of BGB-A3055

Phase 1a: Number of participants with adverse events (AEs)

Phase 1a: Recommended dose for expansion (RDFE) of BGB-A3055

+1 more

Secondary study objectives

Clinical Benefit Rate (CBR)

Disease Control Rate (DCR)

Duration of Response (DoR)

+6 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Phase 1b (Dose Expansion):Experimental Treatment2 Interventions

Participants will receive the recommended dose for expansion phase (RDFE) of BGB-A3055 in combination with tislelizumab to provide additional information on the safety, tolerability, and potential benefits of the recommended dose.

Group II: Phase 1a Part B: Dose Escalation (BGB-A3055 + tislelizumab)Experimental Treatment2 Interventions

Different groups of participants will receive increasing doses of BGB-A3055 in combination with tislelizumab to determine the most appropriate dosage levels.

Group III: Phase 1a Part A: Dose Escalation (BGB-A3055 Monotherapy)Experimental Treatment1 Intervention

Different groups of participants will receive increasing doses of BGB-A3055 alone to determine the most appropriate dosage levels.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tislelizumab

2018

Completed Phase 3

~4560

Do I qualify?Apply below to find out

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

The most common treatments for solid tumors include targeted therapies and immunotherapies. Targeted therapies, such as tyrosine kinase inhibitors, work by specifically targeting and inhibiting molecules involved in tumor growth and progression, thereby blocking the signaling pathways that promote cancer cell proliferation. Immunotherapies, including checkpoint inhibitors like anti-PD-1 and anti-PD-L1 antibodies, enhance the body's immune response against cancer cells by blocking proteins that suppress immune activity. These treatments are crucial for solid tumor patients as they offer more precise and potentially less toxic alternatives to traditional chemotherapy, improving outcomes and quality of life.