BG-C9074 + Tislelizumab for Cancer

Recruiting at 33 trial locations

Overseen By Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: BeiGene

Must not be taking: Antibacterials, Antifungals, Antivirals

Disqualifiers: Brain metastasis, Interstitial lung disease, Diabetes, 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

227 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a first-in-human, dose finding and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C9074 alone and in combination with tislelizumab in participants with advanced solid tumors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have an infection requiring treatment with antibiotics, antifungals, or antivirals, you must complete that treatment at least 14 days before starting the trial.

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

Tislelizumab has shown effectiveness in treating relapsed or refractory classical Hodgkin's lymphoma, with a high overall response rate of 87.1% and complete response in 62.9% of patients in a clinical study. It has also been used in combination with chemotherapy to improve outcomes in advanced nonsquamous non-small cell lung cancer. ^{1 2 3 4 5}

What makes the drug BG-C9074 + Tislelizumab unique for cancer treatment?

Tislelizumab is a unique drug because it is specifically designed to minimize unwanted interactions with other immune system components, potentially reducing side effects. It has shown promise in treating various cancers, including Hodgkin's lymphoma and lung cancer, and offers an economic advantage over other similar drugs, making it a potentially more accessible option for patients. ^{1 2 5 6 7}

Research Team

Study Director

Principal Investigator

BeiGene

Eligibility Criteria

This trial is for adults with advanced solid tumors who've had prior treatment. They must have at least one measurable tumor, provide a tissue sample, and use effective birth control. Participants need to be in good health overall and have an ECOG Performance Status of 1 or less, meaning they are fairly active.

Inclusion Criteria

I am able to sign and date a written consent form before any study-specific procedures or data collection.

I have an advanced cancer that cannot be removed by surgery and I've been treated before.

I have at least one tumor that can be measured.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BG-C9074 alone and in combination with tislelizumab until progressive disease, unacceptable toxicity, withdrawal of consent, or other discontinuation criteria are met

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 3 years

Treatment Details

Interventions

• BG-C9074
• Tislelizumab

Trial Overview The study tests BG-C9074 alone and combined with Tislelizumab to assess safety, tolerability, how the body processes the drugs (PK), their effects on the body (PD), and initial effectiveness against tumors. Treatment can last up to two years unless there's disease progression or unacceptable side effects.

Participant Groups

Group I: Phase 1b: Monotherapy Dose Expansion Experimental Treatment 1 Intervention

The monotherapy dose expansion phase will begin once the BG-C9074 monotherapy RDFE and dosing schedule have been determined from Parts A and B in Phase 1a.

Group II: Phase 1b: Combination Therapy Dose Expansion (BG-C9074 plus tislelizumab) Experimental Treatment 2 Interventions

Combination therapy will begin post-completion of combination dose escalation (Part C, Phase 1a).

Group III: Phase 1a: Part C (Combination Therapy Dose Escalation) Experimental Treatment 2 Interventions

BG-C9074 plus tislelizumab combination at the recommended dose for expansion (RDFE).

Group IV: Phase 1a: Part B (Monotherapy Safety Expansion) Experimental Treatment 1 Intervention

BG-C9074 dose levels that have been determined to be safe and tolerable in Part A will be investigated.

Group V: Phase 1a: Part A (Monotherapy Dose Escalation) Experimental Treatment 1 Intervention

BG-C9074 monotherapy dose escalation

Who Is Running the Clinical Trial?

BeiGene

Lead Sponsor

Trials

216

Recruited

32,500+

Findings from Research

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 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 II study involving Chinese patients with relapsed/refractory classical Hodgkin's lymphoma, tislelizumab demonstrated a high overall response rate of 87.1%, with 62.9% achieving a complete response.

Tislelizumab, a novel anti-PD-1 antibody engineered for improved efficacy, showed promising safety and efficacy, with median progression-free survival and duration of response not yet reached, indicating potential long-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tislelizumab for the treatment of classical Hodgkin's lymphoma. Chen, J., Zhang, H., Zhu, L., et al.[2021]

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 I study involving 32 patients with advanced solid tumors, the combination of ociperlimab and tislelizumab was well tolerated, with no dose-limiting toxicities reported and a recommended phase II dose established at ociperlimab 900 mg plus tislelizumab 200 mg every 3 weeks.

Preliminary results showed an overall response rate of 10% and a disease control rate of 50%, indicating some antitumor activity, which supports further investigation in phase II/III trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AdvanTIG-105: a phase I dose escalation study of the anti-TIGIT monoclonal antibody ociperlimab in combination with tislelizumab in patients with advanced solid tumors. Frentzas, S., Kao, S., Gao, R., et al.[2023]

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]

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]

References

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

Tislelizumab: First Approval. [2020]

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. Spain pubmed.ncbi.nlm.nih.gov

Tislelizumab for the treatment of classical Hodgkin's lymphoma. [2021]

4. 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]

5. England pubmed.ncbi.nlm.nih.gov

AdvanTIG-105: a phase I dose escalation study of the anti-TIGIT monoclonal antibody ociperlimab in combination with tislelizumab in patients with advanced solid tumors. [2023]

6. 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]

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

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