HFB200301 + Tislelizumab for Advanced Cancers

Recruiting in Palo Alto (17 mi)

+8 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: HiFiBiO Therapeutics

Must not be taking: Steroids, Immunosuppressants, CYP450 substrates

Disqualifiers: Autoimmune disease, Uncontrolled diabetes, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a new drug, HFB200301, alone and with another drug, tislelizumab, in adults with advanced cancers. Researchers will start with a low dose and gradually increase it to find the most suitable amount. They will then test this amount in more patients to see how well it works against different cancers.

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

The trial protocol does not specify if you need to stop taking your current medications, but you cannot have had systemic anti-cancer therapy within 2 weeks before starting the study drug or within 4 weeks for immune-oncologic therapy. Also, you should not be on systemic steroid therapy greater than 10 mg/day of prednisone or equivalent within 14 days before the first dose.

What data supports the effectiveness of the drug Tislelizumab for advanced cancers?

Tislelizumab has shown promising anti-tumor effects in various cancers, including lung, liver, and gastric cancers, and has been approved in China for several cancer types. It has also demonstrated similar effectiveness to another well-known drug, pembrolizumab, when combined with chemotherapy for advanced lung cancer. ^{1 2 3 4 5}

Is the combination of HFB200301 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 issues and liver damage. It has been tested in various cancers, and while it has some risks, these are generally manageable. ^{1 3 6 7 8}

What makes the drug HFB200301 + Tislelizumab unique for advanced cancers?

Tislelizumab is a unique drug because it is specifically designed to minimize unwanted interactions with certain immune receptors, potentially reducing side effects compared to other similar drugs. It has shown promise in treating various cancers and may offer an economic advantage over other PD-1 inhibitors, making it a potentially more accessible option for patients. ^{1 2 3 4 9}

Research Team

Eligibility Criteria

Adults with advanced solid tumors like lung, kidney, or skin cancer who've had certain treatments already can join. They need to be well enough for daily activities and able to provide tumor samples. Excluded are those with severe lung conditions, recent major surgery, immune suppressive therapy, unstable health issues, or allergies related to the study drugs.

Inclusion Criteria

I have received at least one treatment for sarcoma.

I have had at least two treatments for my cervical cancer.

I have had at least two treatments for my testicular cancer.

Exclusion Criteria

Persisting toxicity of ≥Grade 2 (≥Grade 1 for diarrhea) relating to prior anti cancer therapy with the following exceptions: All grades of alopecia are acceptable, Endocrine dysfunction on replacement therapy is acceptable, Severe or unstable medical condition, including uncontrolled diabetes, coagulopathy, or unstable psychiatric condition, Major surgery within 4 weeks of the first dose of study drug, History or presence of drug or non-drug induced interstitial lung disease or pneumonitis ≥Grade 2. For combination only: non-small cell lung cancer patients, mesothelioma or patients with significantly impaired pulmonary function or who require supplemental oxygen at baseline must undergo an assessment of pulmonary function at screening, History of allergic reactions, immune related reactions, or cytokine release syndrome (CRS) attributed to compounds of similar chemical or biologic composition to monoclonal antibodies or any excipient of HFB200301, Using sensitive substrates of major cytochrome P450 (CYP450) enzymes, Known active malignancy, with the exception of the specific cancer under investigation in this trial, that required treatment within the previous 2 years

I have had immune therapy for my soft tissue sarcoma or testicular cancer.

I haven't taken high-dose steroids or immune suppressants in the last 2 weeks.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive HFB200301 as a monotherapy or in combination with tislelizumab during dose escalation and expansion phases

16 weeks

4 visits (in-person) per cycle, each cycle is 28 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• HFB200301 (Other)
• Tislelizumab (Monoclonal Antibodies)

Trial Overview The trial is testing HFB200301 alone and combined with Tislelizumab in two parts: first finding a safe dose (escalation) then giving that dose to more people based on their cancer type (expansion). It aims to see how patients tolerate these treatments.

Participant Groups

Group I: Dose Expansion - HFB200301 monotherapy Experimental Treatment 1 Intervention

Participants will be administered HFB200301 at monotherapy RDE as an intravenous infusion.

Group II: Dose Expansion - HFB200301 in combination with tislelizumab Experimental Treatment 2 Interventions

Participations will be administered HFB200301 in combination with tislelizumab at combination RDE as an intravenous infusion.

Group III: Dose Escalation - HFB200301 monotherapy Experimental Treatment 1 Intervention

Participants will be administered HFB200301 at dose levels 1-5 as an intravenous infusion to determine the Recommended Dose for Expansion (RDE).

Group IV: Dose Escalation - HFB200301 in combination with tislelizumab Experimental Treatment 2 Interventions

Participants will be administered HFB200301 at dose levels 1-4 in combination with one dose level of tislelizumab as an intravenous infusion to determine the combination Recommended Dose for Expansion (RDE).

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Mayo Clinic Jacksonville, FL

Mayo Clinic Scottsdale, AZ

Washington University School of Medicine Saint Louis, MO

USC/Norris Comprehensive Cancer Center Los Angeles, CA

More Trial Locations

Who Is Running the Clinical Trial?

HiFiBiO Therapeutics

Lead Sponsor

Trials

5

Recruited

380+

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]

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]

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 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. Switzerland pubmed.ncbi.nlm.nih.gov

Tislelizumab plus chemotherapy versus pembrolizumab plus chemotherapy for the first-line treatment of advanced non-small cell lung cancer: systematic review and indirect comparison of randomized trials. [2023]

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

Tislelizumab: First Approval. [2020]

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

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

5. 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]

6. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tislelizumab for malignant solid tumor: a systematic review and meta-analysis of phase III randomized trials. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Tislelizumab in Asian patients with previously treated locally advanced or metastatic urothelial carcinoma. [2022]

8. 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]

9. Switzerland pubmed.ncbi.nlm.nih.gov

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