What is the mechanism of action of this treatment?

Common treatments for stomach cancer, particularly those involving immunotherapy like HFB200301 and tislelizumab, work by enhancing the body's immune response against cancer cells. Tislelizumab is a PD-1 inhibitor that blocks the interaction between PD-1 proteins on T-cells and PD-L1 proteins on cancer cells, preventing the cancer cells from evading immune detection. HFB200301, while its exact mechanism is not detailed, likely works synergistically with tislelizumab to further boost immune activity against tumors. Understanding these mechanisms is crucial for stomach cancer patients as it highlights the potential for these therapies to improve survival rates by leveraging the body's own immune system to target and destroy cancer cells more effectively.

What side effects are associated with this type of intervention?

Common treatments for stomach cancer, particularly those involving immunotherapy agents like HFB200301 and tislelizumab, often have side effects such as fatigue, diarrhea, and skin reactions (e.g., rash, dry skin). Immunotherapy can also lead to immune-related adverse events, including pneumonitis, colitis, hepatitis, and endocrinopathies. Chemotherapy, another common treatment, typically causes nausea, vomiting, hair loss, and increased risk of infections due to lowered blood cell counts. Targeted therapies may result in hypertension, hand-foot syndrome, and gastrointestinal issues. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several immunotherapies for the treatment of advanced stomach cancer. Pembrolizumab (Keytruda) is an anti-PD-1 monoclonal antibody approved for PD-L1-positive gastric or gastroesophageal junction adenocarcinoma, often used in combination with chemotherapy. Nivolumab (Opdivo), another anti-PD-1 therapy, has been approved for use in combination with chemotherapy for advanced or metastatic gastric cancer. These treatments are similar to the HFB200301 trial, which studies the combination of HFB200301 with tislelizumab, another PD-1 inhibitor, highlighting the ongoing exploration of immunotherapy combinations in advanced stomach cancer.

What other types of research exist?

Promising alternatives to HFB200301 for stomach cancer patients include pembrolizumab (a PD-1 inhibitor) and novel bispecific fusion proteins targeting 4-1BB and PD-L1, which have shown potential in preclinical and clinical studies. Additionally, combination therapies involving PD-L1 inhibitors like atezolizumab or durvalumab with chemotherapy have demonstrated improved survival outcomes in various cancers and may be considered.

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HFB200301 + Tislelizumab for Advanced Cancers

Phase 1

Recruiting

Research Sponsored by HiFiBiO Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cervical cancer: at least 2 lines of therapy

Testicular germ cell tumor: at least 2 lines of therapy

Must not have

Therapeutic radiation therapy within the past 2 weeks

Prior exposure to agents targeting the Tumor Necrosis Factor Receptor type 2 (TNFR2) receptor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up average of 3 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include reactions similar to other monoclonal antibodies such as immune system complications, infusion-related reactions, fatigue, organ inflammation and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I am fully active or restricted in physically strenuous activity but can do light work.

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I have had at least 2 treatments for my head or neck cancer.

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I have melanoma; if it's BRAF V600E mutant, I've had 2 treatments. If not, I've had at least 1.

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I have had at least 2 treatments for my kidney cancer.

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I have had at least 2 treatments for my gastric cancer.

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I have received at least two treatments for mesothelioma.

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I have had at least 2 treatments for my non-small cell lung cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had radiation therapy in the last 2 weeks.

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I have been treated with drugs targeting TNFR2 before.

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I haven't had cancer treatment in the last 2 weeks, or immune therapy in the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ average of 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~average of 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and average of 3 years for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

To assess the pharmacodynamic (PD) effects of HFB200301 as a single agent and in combination

Other study objectives

AUC vs percent change in tumor size

AUC vs percent of Tcell changes in the blood

AUC vs percent of Tcell changes in the tumor

+2 more

Side effects data

From 2022 Phase 3 trial • 512 Patients • NCT03430843

31%

Anaemia

24%

Weight decreased

17%

Cough

16%

Constipation

16%

Decreased appetite

16%

Pyrexia

15%

Nausea

15%

Aspartate aminotransferase increased

14%

Hypoalbuminaemia

13%

Diarrhoea

13%

Alanine aminotransferase increased

13%

Fatigue

12%

Hyponatraemia

12%

Hypothyroidism

11%

Vomiting

11%

Asthenia

11%

Pneumonia

11%

Back pain

10%

Dyspnoea

10%

Pruritus

Dysphagia

Arthralgia

Hypokalaemia

Rash

Insomnia

Hyperglycaemia

Blood alkaline phosphatase increased

Productive cough

Abdominal pain

Malaise

Hypoproteinaemia

Gastrooesophageal reflux disease

White blood cell count increased

Lymphocyte count decreased

Gamma-glutamyltransferase increased

Platelet count decreased

Hypertension

Dizziness

Stomatitis

Blood bilirubin increased

Cancer pain

Hypotension

Oedema peripheral

Pneumonitis

Leukopenia

Haemoptysis

Abdominal pain upper

Abdominal distension

Nasopharyngitis

White blood cell count decreased

Blood creatine phosphokinase MB increased

Blood creatine phosphokinase increased

Upper respiratory tract infection

Myalgia

Hypoglycaemia

Hyperthyroidism

Hyperkalaemia

Hypocalcaemia

Dysphonia

C-reactive protein increased

Hypochloraemia

Hyperuricaemia

Neutrophil count decreased

Thrombocytopenia

Oesophageal obstruction

Upper gastrointestinal haemorrhage

Pneumonia aspiration

Pulmonary haemorrhage

Pleural effusion

Oesophagomediastinal fistula

Oesophageal stenosis

Hypercalcaemia

Neutropenia

Death

Oesophageal fistula

Tumour pain

Multiple organ dysfunction syndrome

Peripheral sensory neuropathy

Immune-mediated lung disease

General physical health deterioration

Immune-mediated myositis

Pulmonary embolism

Sepsis

Type 1 diabetes mellitus

100%

80%

60%

40%

20%

Study treatment Arm

Tislelizumab

Investigator Chosen Chemotherapy (ICC)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Dose Expansion - HFB200301 monotherapyExperimental Treatment1 Intervention

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

Group II: Dose Expansion - HFB200301 in combination with tislelizumabExperimental Treatment2 Interventions

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

Group III: Dose Escalation - HFB200301 monotherapyExperimental Treatment1 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 tislelizumabExperimental Treatment2 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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tislelizumab

2018

Completed Phase 3

~4700

0 / 12Eligibility criteria met

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

Common treatments for stomach cancer, particularly those involving immunotherapy like HFB200301 and tislelizumab, work by enhancing the body's immune response against cancer cells. Tislelizumab is a PD-1 inhibitor that blocks the interaction between PD-1 proteins on T-cells and PD-L1 proteins on cancer cells, preventing the cancer cells from evading immune detection. HFB200301, while its exact mechanism is not detailed, likely works synergistically with tislelizumab to further boost immune activity against tumors. Understanding these mechanisms is crucial for stomach cancer patients as it highlights the potential for these therapies to improve survival rates by leveraging the body's own immune system to target and destroy cancer cells more effectively.

Quality of life with first-line pembrolizumab for PD-L1-positive advanced gastric/gastroesophageal junction adenocarcinoma: results from the randomised phase III KEYNOTE-062 study.Efficacy and safety of anticancer drug combinations: a meta-analysis of randomized trials with a focus on immunotherapeutics and gene-targeted compounds.Molecular-targeted therapy for chemotherapy-refractory gastric cancer: a case report and literature review.