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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 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%
Asthenia
11%
Vomiting
11%
Pneumonia
11%
Back pain
10%
Dyspnoea
10%
Pruritus
9%
Dysphagia
9%
Arthralgia
9%
Hypokalaemia
9%
Rash
8%
Insomnia
7%
Hyperglycaemia
7%
Productive cough
7%
Blood alkaline phosphatase increased
7%
Abdominal pain
6%
Malaise
5%
Lymphocyte count decreased
5%
White blood cell count increased
5%
Hypoproteinaemia
5%
Gastrooesophageal reflux disease
5%
Gamma-glutamyltransferase increased
5%
Platelet count decreased
5%
Hypertension
4%
Blood bilirubin increased
4%
White blood cell count decreased
4%
Hypotension
4%
Cancer pain
4%
Stomatitis
4%
Dizziness
4%
Pneumonitis
4%
Haemoptysis
4%
Abdominal pain upper
4%
Leukopenia
4%
Abdominal distension
4%
Oedema peripheral
4%
Nasopharyngitis
4%
Blood creatine phosphokinase MB increased
4%
Blood creatine phosphokinase increased
3%
Hypocalcaemia
3%
Myalgia
3%
Hypoglycaemia
3%
Upper respiratory tract infection
3%
Hyperkalaemia
3%
Hyperthyroidism
3%
Dysphonia
3%
C-reactive protein increased
2%
Hypochloraemia
2%
Hyperuricaemia
2%
Neutrophil count decreased
2%
Thrombocytopenia
2%
Oesophageal obstruction
2%
Upper gastrointestinal haemorrhage
1%
Oesophageal stenosis
1%
Oesophagomediastinal fistula
1%
Immune-mediated lung disease
1%
Immune-mediated myositis
1%
Pulmonary embolism
1%
General physical health deterioration
1%
Hypercalcaemia
1%
Peripheral sensory neuropathy
1%
Neutropenia
1%
Death
1%
Oesophageal fistula
1%
Multiple organ dysfunction syndrome
1%
Tumour pain
1%
Pleural effusion
1%
Pulmonary haemorrhage
1%
Pneumonia aspiration
1%
Sepsis
1%
Type 1 diabetes mellitus
100%
80%
60%
40%
20%
0%
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
~4730

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.

Find a Location

Who is running the clinical trial?

HiFiBiO TherapeuticsLead Sponsor
4 Previous Clinical Trials
211 Total Patients Enrolled

Media Library

HFB200301 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05238883 — Phase 1
Stomach Cancer Research Study Groups: Dose Escalation - HFB200301 monotherapy, Dose Expansion - HFB200301 in combination with tislelizumab, Dose Expansion - HFB200301 monotherapy, Dose Escalation - HFB200301 in combination with tislelizumab
Stomach Cancer Clinical Trial 2023: HFB200301 Highlights & Side Effects. Trial Name: NCT05238883 — Phase 1
HFB200301 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05238883 — Phase 1
~76 spots leftby Dec 2026