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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 belowSelect...
I have had at least two treatments for my cervical cancer.
Select...
I have had at least two treatments for my testicular cancer.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I have had at least 2 treatments for my head or neck cancer.
Select...
I have melanoma; if it's BRAF V600E mutant, I've had 2 treatments. If not, I've had at least 1.
Select...
I have had at least 2 treatments for my kidney cancer.
Select...
I have had at least 2 treatments for my gastric cancer.
Select...
I have received at least two treatments for mesothelioma.
Select...
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
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 moreOther 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 moreSide effects data
From 2022 Phase 3 trial • 512 Patients • NCT0343084331%
Anaemia
24%
Weight decreased
17%
Cough
16%
Decreased appetite
16%
Constipation
16%
Pyrexia
15%
Aspartate aminotransferase increased
15%
Nausea
14%
Hypoalbuminaemia
13%
Fatigue
13%
Alanine aminotransferase increased
13%
Diarrhoea
12%
Hypothyroidism
12%
Hyponatraemia
11%
Asthenia
11%
Vomiting
11%
Pneumonia
11%
Back pain
10%
Pruritus
10%
Dyspnoea
9%
Arthralgia
9%
Dysphagia
9%
Hypokalaemia
9%
Rash
8%
Insomnia
7%
Hyperglycaemia
7%
Blood alkaline phosphatase increased
7%
Abdominal pain
7%
Productive cough
6%
Malaise
5%
White blood cell count increased
5%
Hypoproteinaemia
5%
Gastrooesophageal reflux disease
5%
Gamma-glutamyltransferase increased
5%
Hypertension
5%
Lymphocyte count decreased
5%
Platelet count decreased
4%
Abdominal pain upper
4%
Nasopharyngitis
4%
Leukopenia
4%
Hypotension
4%
Stomatitis
4%
Oedema peripheral
4%
Blood creatine phosphokinase MB increased
4%
Cancer pain
4%
Haemoptysis
4%
Blood creatine phosphokinase increased
4%
Abdominal distension
4%
Dizziness
4%
Blood bilirubin increased
4%
White blood cell count decreased
4%
Pneumonitis
3%
Myalgia
3%
Upper respiratory tract infection
3%
Hypocalcaemia
3%
Hypoglycaemia
3%
Dysphonia
3%
Hyperthyroidism
3%
C-reactive protein increased
3%
Hyperkalaemia
2%
Neutrophil count decreased
2%
Oesophageal obstruction
2%
Upper gastrointestinal haemorrhage
2%
Hyperuricaemia
2%
Hypochloraemia
2%
Thrombocytopenia
1%
Oesophageal fistula
1%
General physical health deterioration
1%
Peripheral sensory neuropathy
1%
Sepsis
1%
Pleural effusion
1%
Hypercalcaemia
1%
Tumour pain
1%
Multiple organ dysfunction syndrome
1%
Oesophagomediastinal fistula
1%
Oesophageal stenosis
1%
Pneumonia aspiration
1%
Type 1 diabetes mellitus
1%
Immune-mediated myositis
1%
Immune-mediated lung disease
1%
Pulmonary embolism
1%
Pulmonary haemorrhage
1%
Neutropenia
1%
Death
100%
80%
60%
40%
20%
0%
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
Find a Location
Who is running the clinical trial?
HiFiBiO TherapeuticsLead Sponsor
4 Previous Clinical Trials
211 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.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.I can have a biopsy before and during treatment.I am fully active or restricted in physically strenuous activity but can do light work.I have had at least 2 treatments for my head or neck cancer.I have not had radiation therapy in the last 2 weeks.I have melanoma; if it's BRAF V600E mutant, I've had 2 treatments. If not, I've had at least 1.I have had treatments for my advanced cancer.I have had at least 2 treatments for my kidney cancer.I have been treated with drugs targeting TNFR2 before.I have had at least 2 treatments for my gastric cancer.I have received at least two treatments for mesothelioma.I have had at least 2 treatments for my non-small cell lung cancer.I haven't had cancer treatment in the last 2 weeks, or immune therapy in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation - HFB200301 monotherapy
- Group 2: Dose Expansion - HFB200301 monotherapy
- Group 3: Dose Expansion - HFB200301 in combination with tislelizumab
- Group 4: Dose Escalation - HFB200301 in combination with tislelizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this trial available to participants at the present time?
"Data provided by clinicaltrials.gov demonstrates that this medical study, initially posted on March 10th 2022, is actively seeking participants. The trial was last updated on October 5th 2022."
Answered by AI
What is the current capacity of participants for this medical experiment?
"This clinical trial requires 90 qualified individuals to partake in it. Potential participants can find participating sites such as Mayo Clinic located in Rochester, Minnesota and USC/Norris Comprehensive Cancer Center situated nearby Scottsdale, Arizona."
Answered by AI
Has the FDA given its seal of approval to HFB200301?
"Due to the amount of data available regarding its efficacy and safety, HFB200301 has been assigned a score of 1. This is because it is in Phase 1 trials."
Answered by AI
What is the current tally of medical establishments undertaking this clinical experiment?
"Seven different medical centres are presently embracing patients into this trial. These locations, which include Rochester, Scottsdale and Jacksonville among others, have been strategically selected to reduce the burden of travel for enrollees."
Answered by AI
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