BGB-A3055 + Tislelizumab for Cancer

Not currently recruiting at 42 trial locations

Overseen By Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: BeiGene

Disqualifiers: Autoimmune diseases, Brain metastasis, Hepatitis, HIV, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment combination for individuals with certain advanced or metastatic solid tumors that have not responded well to standard therapies. The goal is to determine the treatment's safety, how the body processes it, and its effectiveness against cancer. Participants will receive varying doses of BGB-A3055 (an experimental treatment) alone or with another drug, tislelizumab (an immunotherapy), to identify the safest and most effective dosage. This study suits those with tumors confirmed by a doctor who have not received treatments targeting a specific protein called CCR8. 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.

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

The trial protocol does not specify if you need to stop your current medications. However, since the trial involves testing new cancer treatments, it's possible that some medications might need to be adjusted. Please consult with the trial coordinators for specific guidance.

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 trial coordinators or your doctor to get a clear answer.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Tislelizumab, part of the treatment under study, has been used in other cancer treatments and is generally considered safe. Most individuals tolerate it without major issues. However, specific safety information for using Tislelizumab with BGB-A3055 is not yet available.

Regarding BGB-A3055 alone, limited information exists from human studies as it remains in early development. Safety data is still being collected. This early-phase study primarily focuses on assessing the safety and tolerability of the combination. Safety is closely monitored and evaluated.

Participants considering this study should be aware that while Tislelizumab has a history of manageable safety, the combination with BGB-A3055 is still under careful investigation for potential side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about BGB-A3055 and tislelizumab because they offer a novel approach to cancer treatment. Unlike standard therapies that often target the cancer directly, BGB-A3055 and tislelizumab work by enhancing the body's immune response against cancer cells. BGB-A3055 is designed to inhibit specific pathways that tumors use to grow and spread, while tislelizumab is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer. This combination could potentially lead to more effective and targeted cancer treatments with fewer side effects compared to traditional chemotherapy.

What evidence suggests that this trial's treatments could be effective for cancer?

Research has shown that BGB-A3055 is a new antibody targeting a protein called CCR8 on certain immune cells, potentially aiding the immune system in attacking cancer cells. In lab studies, BGB-A3055 proved very effective against these cells. In this trial, some participants will receive BGB-A3055 alone to determine appropriate dosage levels. Others will receive BGB-A3055 combined with Tislelizumab, a treatment known to help some cancer patients live longer, to explore potential enhanced outcomes. Tislelizumab helps the immune system recognize and fight cancer cells. Together, these treatments aim to boost the body's natural ability to fight tumors. Early results are promising, but ongoing studies will provide more information. ^{1 2 3 4 6}

Who Is on the Research Team?

Study Director

Principal Investigator

BeiGene

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am at least 18 years old or the legal age of consent in my area.

>=1 Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

I can perform all my usual activities without help and my organs are functioning well.

Exclusion Criteria

I have chronic hepatitis B with high viral load, or I have active hepatitis C or HIV.

Active autoimmune diseases or history of autoimmune diseases that may relapse

I do not have untreated brain cancer spread or active spinal cord disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BGB-A3055 alone or in combination with tislelizumab, with dose escalation to determine the most appropriate dosage levels

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term if they benefit from the treatment

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• BGB-A3055
• Tislelizumab

Trial Overview 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.

How Is the Trial Designed?

Group I: Phase 1b (Dose Expansion): Experimental Treatment 3 Interventions

Participants will receive the recommended dose for expansion (RDFE) of BGB-A3055 in combination with tislelizumab with or without chemotherapy 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 Treatment 2 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 Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

BeiGene

Lead Sponsor

Trials

216

Recruited

32,500+

Published Research Related to This Trial

Atezolizumab therapy significantly improves overall survival (median OS of 11.2 months) in patients with previously treated advanced non-small cell lung cancer (NSCLC), demonstrating its efficacy in a diverse patient population.

The treatment has a manageable safety profile, with serious adverse events occurring in only 8.0% of patients and no new safety signals identified, indicating it is a viable option for patients often excluded from clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Final results from TAIL: updated long-term efficacy of atezolizumab in a diverse population of patients with previously treated advanced non-small cell lung cancer. Ardizzoni, A., Azevedo, S., Rubio-Viqueira, B., et al.[2022]

Tislelizumab is a modified PD-1 antibody that effectively inhibits tumor growth in various cancers, including Hodgkin's lymphoma and lung cancer, and has received multiple approvals in China for its use.

It has a favorable safety profile with common side effects like fatigue and anemia, and it offers economic advantages over other PD-1 inhibitors, making it a promising option for cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tislelizumab: A Modified Anti-tumor Programmed Death Receptor 1 Antibody. Zhang, L., Geng, Z., Hao, B., et al.[2023]

In a phase IA/IB study involving 451 patients with advanced solid tumors, tislelizumab demonstrated an acceptable safety profile, with most adverse events being mild (grade 1-2), and only 5.3% of patients discontinuing treatment due to side effects.

Tislelizumab showed promising antitumor activity, with 18% of patients in phase IA and 12% in phase IB achieving confirmed objective responses, leading to the recommendation of a dosing schedule of 200 mg every 3 weeks for future trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase IA/IB study of single-agent tislelizumab, an investigational anti-PD-1 antibody, in solid tumors. Desai, J., Deva, S., Lee, JS., et al.[2021]

Tislelizumab, an anti-PD-1 monoclonal antibody, shows improved progression-free survival and objective response rates in treating non-small cell lung cancer (NSCLC), especially when combined with chemotherapy, based on a review of four randomized controlled trials involving 1565 patients.

While tislelizumab is generally effective, it is associated with treatment-emergent adverse events, including significant hematologic issues and immune-mediated effects like hypothyroidism and pneumonitis, with a mortality rate from these events ranging from 3.2% to 4.2%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety and efficacy of tislelizumab, alone or in combination with chemotherapy, for the treatment of non-small cell lung cancer: a systematic review of clinical trials. Daei Sorkhabi, A., ZareDini, M., Fazlollahi, A., et al.[2023]

In a phase II study with 70 patients suffering from relapsed/refractory classical Hodgkin lymphoma, tislelizumab showed a high overall response rate of 87.1% and a complete response rate of 67.1% after a median follow-up of 33.8 months, indicating its efficacy as a treatment option.

The treatment demonstrated a favorable safety profile, with 97.1% of patients experiencing treatment-related adverse events, but only 31.4% having severe (grade ≥3) events, and just 8.6% discontinuing treatment due to adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tislelizumab for Relapsed/Refractory Classical Hodgkin Lymphoma: 3-Year Follow-up and Correlative Biomarker Analysis. Song, Y., Gao, Q., Zhang, H., et al.[2023]

Tislelizumab is an anti-PD-1 monoclonal antibody developed as an immunotherapy for cancer, specifically approved in December 2019 in China for relapsed or refractory classical Hodgkin's lymphoma after at least two prior chemotherapy treatments.

The drug has shown promise in treating both hematological cancers and advanced solid tumors, indicating its potential for future approvals in additional cancer types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tislelizumab: First Approval. Lee, A., Keam, SJ.[2020]

In a study of 115 patients with recurrent or metastatic cervical cancer treated with tislelizumab, the overall response rate was 39.1%, and the median progression-free survival was 19.6 months, indicating promising antitumor activity.

Baseline serum C-reactive protein (CRP) levels and the CRP-to-albumin ratio (CAR) were identified as independent risk factors for predicting the efficacy and prognosis of tislelizumab treatment, with higher levels associated with shorter progression-free and overall survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tislelizumab for cervical cancer: A retrospective study and analysis of correlative blood biomarkers. Zheng, X., Gu, H., Cao, X., et al.[2023]

Tislelizumab, an immune checkpoint inhibitor, has shown promising results as a first-line treatment for a cisplatin-ineligible patient with metastatic urothelial carcinoma (mUC), achieving a complete response and over 16 months of progression-free survival.

This case is significant as it is the first report of tislelizumab being effective in a cisplatin-ineligible mUC patient with specific characteristics (PD-L1-negative, microsatellite stable, high tumor mutational burden), highlighting the need for further studies to evaluate its efficacy in similar patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complete response to tislelizumab in a metastatic urothelial carcinoma after surgery associated with high tumor mutational burden: a case report. Jin, J., Yang, Q., Yu, Y., et al.[2023]

In a phase 3 trial involving 332 patients with advanced nonsquamous non-small cell lung cancer (nsq-NSCLC), the combination of tislelizumab and chemotherapy significantly improved progression-free survival (PFS) compared to chemotherapy alone, with a median PFS of 9.7 months versus 7.6 months.

The addition of tislelizumab also resulted in higher response rates and longer duration of response, making it a promising first-line treatment option for patients with advanced nsq-NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tislelizumab Plus Chemotherapy as First-Line Treatment for Locally Advanced or Metastatic Nonsquamous NSCLC (RATIONALE 304): A Randomized Phase 3 Trial. Lu, S., Wang, J., Yu, Y., et al.[2021]

Atezolizumab treatment in 615 patients with previously treated advanced non-small cell lung cancer showed a median overall survival of 11.1 months and a median progression-free survival of 2.7 months, indicating its efficacy in this population.

The safety profile was manageable, with treatment-related serious adverse events occurring in 7.8% of patients and immune-related adverse events in 8.3%, confirming that atezolizumab can be safely administered even to patients with severe renal impairment and other challenging conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary results from TAIL: a global single-arm safety study of atezolizumab monotherapy in a diverse population of patients with previously treated advanced non-small cell lung cancer. Ardizzoni, A., Azevedo, S., Rubio-Viqueira, B., et al.[2021]

Citations

1. aacrjournals.org aacrjournals.org/cancerres/article/85/8_Supplement_1/4787/758533/Abstract-4787-BGB-A3055-an-afucosylated-anti-CCR8

Abstract 4787: BGB-A3055, an afucosylated anti-CCR8 ... BGB-3055 is a novel fully humanized afucosylated antibody that has high binding affinity to hCCR8, strong CCL1-CCR8 blocking capacity and potent ADCC effect.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05935098

BGB-A3055 Alone and in Combination With Tislelizumab ... This study aims to evaluate how safe and well-tolerated the treatment is, how the body processes it, how it works on the tumors, and whether it shows early ...

3. beonemedinfo.com beonemedinfo.com/CongressDocuments/Wang_Preclinical_BGBA3055_AACR_Poster_2025.pdf

BGB-A3055, an afucosylated anti-CCR8 antibody, ... The results showed BGB-A3055 induced potent ADCC activity against primary Treg cells with an average EC50 of 0.08 nM. Anti-CCR8 Antibody ...

4. trial.medpath.com trial.medpath.com/clinical-trial/b412fae950cf1c37

BGB-A3055 Alone and in Combination With Tislelizumab in ... This study aims to evaluate how safe and well-tolerated the treatment is, how the body processes it, how it works on the tumors, and whether it shows early ...

5. withpower.com withpower.com/trial/phase-1-neoplasms-7-2023-aba1a

BGB-A3055 + Tislelizumab for Cancer · Info for Participants ... survival of 11.1 months and a median progression-free survival of 2.7 months, indicating its efficacy in this population. The safety profile was manageable ...

6. synapse.patsnap.com synapse.patsnap.com/drug/166d1954ae664cc1acdb3515734d03b9

BGB-A3055 - Drug Targets, Indications, Patents A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-A3055, ...