BGB-A3055 + Tislelizumab for Cancer

Recruiting at 36 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

263 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the idea that BGB-A3055 + Tislelizumab for Cancer is an effective drug?

The available research shows that Tislelizumab, when used in combination with other treatments, has shown promising results in treating various types of cancer. It has been approved in China for several cancers, including Hodgkin's lymphoma and lung cancer, due to its satisfactory anti-tumor effects. Tislelizumab has also been found to improve outcomes when combined with chemotherapy for advanced lung cancer compared to chemotherapy alone. Additionally, it has an economic advantage over other similar drugs, making it a potentially more accessible option for patients. ^{1 2 3 4 5}

What data supports the effectiveness of the drug Tislelizumab in treating cancer?

Tislelizumab has shown promising anti-tumor effects in various cancers, including Hodgkin's lymphoma, lung cancer, and liver cancer, and has been approved in China for several cancer types. It has also been found to improve outcomes when combined with chemotherapy in advanced lung cancer. ^{1 2 3 4 5}

What safety data is available for BGB-A3055 and Tislelizumab in cancer treatment?

Tislelizumab, an anti-PD-1 antibody, has shown an acceptable safety profile in clinical studies for various cancers. Common adverse effects include fatigue, anemia, and decreased neutrophil count, with serious events related to respiratory infection or hepatic injury. It has been approved in China for several cancers and has orphan designations in the US for specific cancers. No specific safety data for BGB-A3055 was found in the provided research. ^{1 2 6 7 8}

Is the combination of BGB-A3055 and Tislelizumab safe for humans?

Tislelizumab has been shown to have an acceptable safety profile in humans, with common side effects like fatigue and anemia, and more serious risks such as respiratory infections and liver damage. It has been used in various cancer treatments, indicating it is generally safe, but specific safety data for the combination with BGB-A3055 is not provided. ^{1 2 6 7 8}

Is the drug BGB-A3055, Tislelizumab a promising treatment for cancer?

Yes, Tislelizumab is a promising drug for cancer treatment. It has shown positive effects in various cancers like Hodgkin's lymphoma, lung cancer, and liver cancer. It is approved in China for several types of cancer and has been recognized by the US FDA for its potential in treating certain cancers. It also offers an economic advantage over other similar drugs, making it a valuable option for cancer patients. ^{1 2 3 5 9}

What makes the drug BGB-A3055 + Tislelizumab unique for cancer treatment?

Tislelizumab is a unique drug because it is specifically designed to minimize unwanted immune interactions, which can improve its effectiveness and safety in treating various cancers. It has shown promise in treating several types of tumors and is more cost-effective compared to other similar drugs, potentially reducing the financial burden on patients. ^{1 2 3 5 10}

Research Team

Study Director

Principal Investigator

BeiGene

Eligibility Criteria

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.

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

Active autoimmune diseases or history of autoimmune diseases that may relapse

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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]

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, 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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Tislelizumab: A Modified Anti-tumor Programmed Death Receptor 1 Antibody. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Tislelizumab for Relapsed/Refractory Classical Hodgkin Lymphoma: 3-Year Follow-up and Correlative Biomarker Analysis. [2023]

3. United States 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. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Phase IA/IB study of single-agent tislelizumab, an investigational anti-PD-1 antibody, in solid tumors. [2021]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Tislelizumab: First Approval. [2020]

6. England 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. [2022]

7. England 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. [2023]

8. England 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. [2021]

9. England 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. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Tislelizumab for cervical cancer: A retrospective study and analysis of correlative blood biomarkers. [2023]