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BIO-106 for Cancer

NEXT Oncology Austin, Austin, TX
Cancer+3 More ConditionsBIO-106 - Drug
Eligibility
18+
All Sexes

Study Summary

This trial is testing a new cancer drug, BIO-106, as a possible treatment for advanced cancer. This drug will be tested alone and in combination with another cancer drug, pembrolizumab.

Eligible Conditions
  • Cancer
  • Advanced Solid Tumors
  • Advanced Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1 & 2

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Study Objectives

4 Primary · 6 Secondary · Reporting Duration: 2 years

1 year
Anti-tumor activity by objective response rate (ORR), disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS) - (Phase 1)
Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1)
Maximum tolerable dose (MTD) or a tolerated dose below MTD - (Phase 1)
2 years
Anti-tumor activity by objective response rate (ORR), disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS) - (Phase 2)
Incidence of adverse event of special interest (AESI) - (Phase 2)
Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 2)
Incidence of anti-BIO-106 antibodies - (Phase 1/2)
PK (AUC) of BIO-106 - (Phase 1/2)
PK (Cmax) of BIO-106 - (Phase 1/2)
up to 21 days
Incidence and nature of dose-limiting toxicities (DLTs) - (Phase 1)

Trial Safety

Phase-Based Safety

1 of 3

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Side Effects for

Arm A (Phased Pembrolizumab Regimen)
71%Fatigue
43%Peripheral sensory neuropathy
38%Alopecia
38%Headache
33%Nausea
29%Cough
29%Dyspnea
29%Hypothyroidism
29%Pain
24%Rash maculo-papular
24%Constipation
19%Bloating
19%Dyspepsia
19%Anorexia
19%Diarrhea
19%Abdominal pain
19%Pain in extremity
19%Infusion related reaction
14%Hyperglycemia
14%Anemia
14%Sinusitis
14%Dehydration
14%Nasal congestion
14%Allergic rhinitis
14%Edema limbs
14%Hypokalemia
10%Alanine aminotransferase increased
10%Hyperthyroidism
10%Mucositis oral
10%Vomiting
10%Localized edema
10%Neutrophil count decreased
10%Myalgia
10%Hoarseness
10%Pneumonitis
10%Skin infection
10%Dizziness
10%Restlessness
10%Pruritus
10%Hot flashes
10%Thromboembolic event
10%Dry mouth
10%Fall
10%Lymphedema
10%Chills
10%Aspartate aminotransferase increased
10%Back pain
10%Flushing
5%Hypotension
5%Recurrent laryngeal nerve palsy
5%Hepatobiliary disorders - Other, specify
5%Hepatic failure
5%Atrial flutter
5%Malaise
5%Non-cardiac chest pain
5%Infections and infestations - Other, specify
5%Mucosal infection
5%Bruising
5%Blood bilirubin increased
5%Metabolism and nutrition disorders - Other, specify
5%Urinary tract pain
5%Postnasal drip
5%Hypertension
5%Fever
5%Upper respiratory infection
5%Creatinine increased
5%Nail loss
5%Nail ridging
5%Lymph gland infection
5%Lung infection
5%Sneezing
5%Hypoglycemia
5%Urinary incontinence
5%Respiratory failure
5%Nail infection
5%Hypophosphatemia
5%Dysgeusia
5%Syncope
5%Insomnia
5%Urinary frequency
5%Urinary urgency
5%Hypoxia
5%Sore throat
5%Eye disorders - Other, specify
5%Urinary tract infection
5%Alkaline phosphatase increased
5%Epistaxis
5%Laryngeal hemorrhage
5%Skin hyperpigmentation
5%Hyponatremia
5%Periorbital edema
5%Gastrointestinal disorders - Other
5%Platelet count decreased
5%Bone pain
5%Conjunctivitis
5%Flashing lights
5%Allergic reaction
5%Hypocalcemia
5%Hypomagnesemia
This histogram enumerates side effects from a completed 2022 Phase 2 trial (NCT03018080) in the Arm A (Phased Pembrolizumab Regimen) ARM group. Side effects include: Fatigue with 71%, Peripheral sensory neuropathy with 43%, Alopecia with 38%, Headache with 38%, Nausea with 33%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Single agent BIO-106
1 of 2
Combination BIO-106 plus pembrolizumab
1 of 2

Experimental Treatment

332 Total Participants · 2 Treatment Groups

Primary Treatment: BIO-106 · No Placebo Group · Phase 1 & 2

Single agent BIO-106
Drug
Experimental Group · 1 Intervention: BIO-106 · Intervention Types: Drug
Combination BIO-106 plus pembrolizumabExperimental Group · 2 Interventions: BIO-106, Pembrolizumab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2200

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

BiOneCure Therapeutics Inc.Lead Sponsor
BiOneCure Clinical DevelopmentStudy DirectorBiOneCure Therapeutics Inc.

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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References

Frequently Asked Questions

What goals does this research hope to achieve?

"The primary goal of this long-term study is to document the rate of adverse events and serious adverse events during Phase 1. Additionally, researchers will be looking at anti-tumor activity, defined by objective response rate, disease control rate, duration of response, progression-free survival, and overall survival. These outcomes will also be measured during Phase 2 which is further broken down into an escalation period and expansion period." - Anonymous Online Contributor

Unverified Answer

Are people still being signed up for this experiment?

"Yes, this study is still recruiting patients. The listing on clinicaltrials.gov shows that it was first posted on March 25th, 2022 and updated as recently as July 15th, 2022." - Anonymous Online Contributor

Unverified Answer

How many individuals are being given this opportunity to participate in this clinical trial?

"That is correct. According to the information available on clinicaltrials.gov, this research is still looking for patients to enroll. The original posting was March 25th, 2022 and there have been updates as recently as July 15th, 2022. They are currently hoping to enroll 332 individuals from 3 different locations." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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