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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up average of 3 years

Awards & highlights

Study Summary

This trial is testing a new cancer drug to see if it is safe and effective. Patients will be assigned to groups based on their cancer type to test the drug's effectiveness.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with adverse events (AEs), serious AEs (SAEs), dose-limiting toxicities (DLTs), and tolerability (dose interruptions, reductions, and dose intensity)

To determine a Recommended Phase 2 Dose (RP2D) during Dose Expansion

Secondary outcome measures

Area under the concentration versus time curve (AUC)

Disease Control Rate (DCR)

Duration of Response (DOR)

+6 more

Other outcome measures

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%

Pyrexia

16%

Decreased appetite

15%

Nausea

15%

Aspartate aminotransferase increased

14%

Hypoalbuminaemia

13%

Diarrhoea

13%

Fatigue

13%

Alanine aminotransferase increased

12%

Hypothyroidism

12%

Hyponatraemia

11%

Back pain

11%

Vomiting

11%

Asthenia

11%

Pneumonia

10%

Dyspnoea

10%

Pruritus

Dysphagia

Hypokalaemia

Arthralgia

Rash

Insomnia

Abdominal pain

Blood alkaline phosphatase increased

Hyperglycaemia

Productive cough

Malaise

Gastrooesophageal reflux disease

Gamma-glutamyltransferase increased

Lymphocyte count decreased

Platelet count decreased

White blood cell count increased

Hypertension

Hypoproteinaemia

Oedema peripheral

Leukopenia

Stomatitis

White blood cell count decreased

Abdominal distension

Abdominal pain upper

Blood bilirubin increased

Nasopharyngitis

Blood creatine phosphokinase MB increased

Blood creatine phosphokinase increased

Cancer pain

Dizziness

Haemoptysis

Hypotension

Pneumonitis

Hypoglycaemia

Hyperthyroidism

Upper respiratory tract infection

C-reactive protein increased

Hypocalcaemia

Hyperkalaemia

Myalgia

Dysphonia

Oesophageal obstruction

Neutrophil count decreased

Hypochloraemia

Upper gastrointestinal haemorrhage

Hyperuricaemia

Thrombocytopenia

General physical health deterioration

Multiple organ dysfunction syndrome

Oesophageal stenosis

Oesophageal fistula

Death

Oesophagomediastinal fistula

Pneumonia aspiration

Sepsis

Hypercalcaemia

Type 1 diabetes mellitus

Immune-mediated myositis

Tumour pain

Immune-mediated lung disease

Pleural effusion

Pulmonary embolism

Pulmonary haemorrhage

Neutropenia

Peripheral sensory neuropathy

100%

80%

60%

40%

20%

Study treatment Arm

Tislelizumab

Investigator Chosen Chemotherapy (ICC)

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

~4260

0 / 9Eligibility 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.