Refractory Solid TumorsPhase 1NCT05150457
Safety and Preliminary Efficacy of BNA035 in Patients With Advanced Solid Tumors
A Phase 1 study testing BNA035 in people with Refractory Solid Tumors, run by Binacea Pharma, Inc. at 3 sites in Australia.
Trial summary
The purpose of the study is to evaluate the safety and tolerability of BNA035 in order to determine the maximum tolerated dose (MTD) and Recommended Phase 2 dose (RP2D) and to evaluate the preliminary efficacy for each combination regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Solid Tumors
- What is being tested?
- BNA035
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 3 sitesAustralia
- Study dates
- 8 Feb 2022to Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet all of the following criteria to be eligible for enrollment in this study:
- Male or female ≥ 18 years of age.
- Histologically or cytologically confirmed advanced malignant solid tumor that is refractory to or intolerant of all standard therapy or for which no standard therapy is available.
- Measurable disease as per RECIST 1.1, or per Response Assessment in Neuro-Oncology (RANO) criteria for patients with glioblastoma multiforme and documented by computed tomography (CT) and/or magnetic resonance imaging (MRI).
- All persisting toxic effects of any prior anti-tumor therapy resolved to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 Grade ≤ 1 or baseline before the first dose of study drug (with the exception of alopecia [Grade 1 or 2 permitted] and neurotoxicity [Grade 1 or 2 permitted]).
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
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- Life expectancy of ≥ 3 months, in the opinion of the Investigator.
- Adequate organ function defined as follows:
- Hematologic: Platelets ≥ 100 x 109/L; Hemoglobin ≥ 9.0 g/dL; Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (without blood transfusion, platelet transfusion, or growth factors within previous 7 days of the hematologic laboratory values obtained at Screening visit).
- Hepatic: Aspartate aminotransferase (AST)/ Alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN) (if liver metastases are present, ≤ 5 x ULN); Total or conjugated bilirubin ≤ 1.5 x ULN.
- Renal: Creatinine clearance (CLcr) ≥ 45 mL/min as calculated by the Cockcroft Gault method.
- Coagulation: Patients on full-dose oral anticoagulation, except warfarin, which is an excluded medication, must be on a stable dose (minimum duration 14 days). Patients on low molecular weight heparin will be allowed.
- Negative serum pregnancy test for female patients.
- If of childbearing potential, female patients must be willing to use highly effective double contraceptive measures starting with the Screening visit through 90 days after the last dose of study treatment.
- Double contraception is defined as a condom AND one other form of the following:
- Established hormonal contraception (with approved oral contraceptive pills, long-acting implantable hormones, injectable hormones);
- A vaginal ring or an intrauterine device (IUD);
- Documented evidence of surgical sterilization at least 6 months prior to Screening (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy for women or vasectomy for men [with appropriate post-vasectomy documentation of the absence of sperm in semen] provided the male partner is a sole partner).
- Women not of childbearing potential must be post-menopausal for ≥ 12 months. Post-menopausal status will be confirmed through testing of follicle-stimulating hormone (FSH) levels ≥ 40 IU/L at Screening for amenorrhoeic female participants. Females who are abstinent from heterosexual intercourse will also be eligible.
- Periodic abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are not considered highly effective methods of birth control. Complete abstinence for the duration of the study through 90 days after the last dose of study treatment is acceptable if this is the established and preferred contraception for the patient.
- Female patients who are in same-sex relationships are not required to use contraception.
- Male patients with a female partner(s) of childbearing potential must agree to use highly effective contraceptive measures throughout the trial starting with the Screening visit through 90 days after the last dose of study treatment is received. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner.
- Acceptable methods of contraception include:
- Vasectomy (> 30 days since vasectomy with no viable sperm);
- Surgical sterility in female partner(s) (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy);
- Double contraception, condom AND the use of an effective contraceptive for the female partner that includes: oral contraceptive pills, long-acting implantable hormones, injectable hormones, a vaginal ring or an IUD.
- Patients with same-sex partners (abstinence from penile-vaginal intercourse) are eligible when this is their preferred and usual lifestyle.
- Note: Abstinence is acceptable if this is the established and preferred contraception method for the patient.
- Males must not donate sperm for at least 90 days after the last dose of study drug.
- Able and willing to provide written informed consent to participate in the study.
- Patients with history of human immunodeficiency virus (HIV) infection should have a cluster of differentiation 4+ (CD4+) T cell count ≥ 350 cells/µL at Screening.
- Patients with serological evidence of chronic hepatitis B virus infection (HBV) should have HBV viral load below the limit of quantification at Screening.
- Patients with serological evidence of hepatitis C virus infection (HCV) should have completed curative antiviral treatment and have HCV viral load below the limit of quantification at Screening.
- Patients must not be using immunosuppressive medication > 10 mg prednisolone per day or equivalent, or 2 mg dexamethasone for glioblastoma multiforme (GBM) patients, within 14 days prior to the first dose of the study drug. Note: Use of immunosuppressive medications as prophylaxis in patients with contrast allergies are acceptable. In addition, temporary uses of corticosteroids considered non-clinically significant may be approved on a case-by-case basis in discussion with the Sponsor.
Who cannot join
- Patients who meet any of the following criteria will be excluded from this study:
- Pregnant or lactating or planning to become pregnant (self or partner) at any time during the study, including the Follow-up Period.
- History or evidence of clinically significant disorder, condition, or disease that, in the opinion of the Investigator or Medical Monitor, would pose a risk to patient safety or interfere with the study evaluations, procedures, or completion.
- History of ≥ Grade 3 AEs during prior treatment with an immune checkpoint inhibitor, or history of discontinuation of treatment with an immune checkpoint inhibitor due to AEs. Previous Grade 3 immune-related adverse events (irAEs) if not considered by the Investigator to increase the patient's risk for investigational product (IP) related AEs, may be approved on a case-by-case basis in discussion with the Sponsor (e.g., hypothyroidism on stable thyroxine replacement, adrenal insufficiency on stable hormone replacement therapy, diabetes on stable insulin therapy).
- Active or history of prior autoimmune disease with the exception of:
- Hashimoto's Thyroiditis on stable thyroid replacement therapy;
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- Type 1 Diabetes Mellitus (T1DM) on stable insulin therapy;
- Other prior autoimmune disorders not considered to put at higher risk for irAEs, based on Investigator judgment and approved by the Sponsor on a case-by-case basis (e.g., rheumatoid arthritis).
- The use of stable and controlled low dose steroids is acceptable.
- Patient has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry, have no evidence of new or enlarging brain metastases, and if taking corticosteroids, are on stable or decreasing doses for at least 7 days from first dose of study drug. Patients with GBM are eligible, if meeting all other inclusion criteria and no exclusion criteria.
- Patients with hepatocellular carcinoma are excluded.
- Uncontrolled intercurrent illness including, but not limited to, active uncontrolled infection requiring systemic therapy, active or chronic bleeding event within 28 days prior to first dose of study drug, or psychiatric illness/social situation that would limit compliance with study requirements as judged by the treating physician.
- Current or previous interstitial lung disease.
- Myocardial infarction, symptomatic congestive heart failure (New York Heart Association Classification > Class II), unstable angina, serious uncontrolled cardiac arrhythmia, cerebral vascular accident, coronary/peripheral artery bypass graft surgery, or pulmonary embolism within the last 6 months of first dose of study drug. Patients with small pulmonary embolism not thought to put patients at higher risks of AEs may be allowed on a case-by-case basis in discussion with the Sponsor.
- Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e., larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy) within 28 days of the first dose of study drug.
- Symptomatic with uncontrolled ascites or pleural effusion. A patient who is clinically stable following treatment for these conditions (including thoracentesis or paracentesis), with no need for repeating paracentesis/thoracentesis within 7 days prior to Cycle 1 Day 1 (C1D1), is eligible.
- Minor surgical procedure(s) within 7 days of enrollment, or not yet recovered from prior surgery (placement of central venous access device, fine needle aspiration, or endoscopic biliary stent ≥ 1 day before enrollment is acceptable).
- Prior systemic radiation therapy completed within 4 weeks of the first dose of study drug, prior local radiation therapy completed within 2 weeks of C1D1, or radiopharmaceuticals (strontium, samarium) within 8 weeks of C1D1. Palliative radiotherapy given within 14 days prior to the first dose of study drug may be approved on a case-by-case basis in discussion with the Sponsor.
- Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy) within 28 days or 5 half-lives, whichever is shorter, of study drug dosing (6 weeks for nitrosoureas, mitomycin C, or molecular agents with t1/2 > 10 days).
- History of long QT syndrome or additional risk factors for Torsades de Pointes or whose corrected QT interval (QTc) measured (Fridericia method) at Screening is prolonged (> 480 ms).
- Use of concomitant medications that prolong QT/QTc interval at Screening that cannot be discontinued.
- Known hypersensitivity to study drug, the metabolites or formulation excipients.
- Use of any prohibited concomitant medications as described in Section 5.7.3 and any investigational agent within 2 weeks of study treatment initiation.
- Received live virus vaccination within 30 days of first dose of study treatment. Seasonal flu vaccines that do not contain live virus are permitted.
- History of hematologic stem cell transplant or solid organ transplant.
- Participation or plans to participate in another interventional clinical study while taking part in this protocol; participation in an observational study is acceptable.
Trial locations and contacts
3 sites in 1 country.
Australia3 sites, 3 recruiting
- Recruiting
Pindara Private Hospital
Benowa, Queensland, 4217
Andrea Tazbirkova, MD, 07 5588 9093, tazbirkova@yahoo.com
Teagan Holland, 07 5588 9093, HollandT@ramsayhealth.com.au
- Recruiting
St. Vincents Hospital Melbourne
Fitzroy, Victoria, 3065
Melissa Moore, MD, 03 9231 3554, Melissa.Moore@svha.org.au
Melissa Moore, MD
- Recruiting
St George Private Hospital
Kogarah, New South Wales, 2217
Paul De Souza, MD, +61-2-4221-5905 ext. 9744, paulds@uow.edu.au
Hui Li, BSc, +61-2-9598-5079, LiH@ramsayhealth.com.au
About this study
Official title: A Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BNA035 in Patients With Advanced Solid Tumors
The purpose of the study is to evaluate the safety and tolerability of BNA035 in order to determine the maximum tolerated dose (MTD) and Recommended Phase 2 dose (RP2D) and to evaluate the preliminary efficacy for each combination regimen.
- Conditions
- Refractory Solid Tumors
- Being tested
- BNA035
- Keywords
- Cancer, Advanced cancer, Recurrent cancer, Solid tumor, Metastatic cancer, Refractory cancer
- Medical subject headings
- Neoplasms, Recurrence, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNA035Drug
Anti-epidermal growth factor receptor (Anti-EGFR) and anti-cluster of differentiation 137 (anti-CD137) bispecific antibody
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Phase, Dose Level 1 | Experimental | Starting dose level of BNA035 administered as an IV infusion once weekly in 28 day cycles.
Drug: BNA035 Administered once weekly as an IV infusion at the assigned dose level in 28 day cycles Receives: Drug: BNA035 |
| Dose Escalation Phase, Dose Level 2 | Experimental | 3 times the starting dose level of BNA035 administered as an IV infusion once weekly in 28 day cycles Drug: BNA035 Administered once weekly as an IV infusion at the assigned dose level in 28 day cycles Receives: Drug: BNA035 |
| Dose Escalation Phase, Dose Level 3 | Experimental | 10 times the starting dose level of BNA035 administered as an IV infusion once weekly in 28 day cycles Drug: BNA035 Administered once weekly as an IV infusion at the assigned dose level in 28 day cycles Receives: Drug: BNA035 |
| Dose Escalation Phase, Dose Level 4 | Experimental | 30 times the starting dose level of BNA035 administered as an IV infusion once weekly in 28 day cycles Drug: BNA035 Administered once weekly as an IV infusion at the assigned dose level in 28 day cycles Receives: Drug: BNA035 |
| Dose Escalation Phase, Dose Level 5 | Experimental | 100 times the starting dose level of BNA035 administered as an IV infusion once weekly in 28 day cycles Drug: BNA035 Administered once weekly as an IV infusion at the assigned dose level in 28 day cycles Receives: Drug: BNA035 |
| Dose Escalation Phase, Dose Level 6 | Experimental | 200 times the starting dose level of BNA035 administered as an IV infusion once weekly in 28 day cycles Drug: BNA035 Administered once weekly as an IV infusion at the assigned dose level in 28 day cycles Receives: Drug: BNA035 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the Maximum Tolerated Dose (MTD) Recommended Phase 2 Dose (RP2D) of BNA035 in patients with advanced solid tumors.
Evaluated by the number of dose-limiting toxicities (DLT) graded using NCI CTCAE v 5.0
Measured: From first dose of BNA035 (Cycle 1 Day 1) through the end of the DLT period (28 days from Cycle 1 Day 1)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
To examine the incidence of clinical and laboratory adverse events after multiple doses of BNA035 in the dose escalation and dose expansion phases.
Measured: From first dose of BNA035 through 90 days after the last BNA035 dose)
Secondary outcomes (4)
Peak Plasma Concentration of BNA035
To evaluate the maximum observed concentration (Cmax) after single and repeated IV weekly doses of BNA035
Measured: Days 1, 2, 3, 5, and 8 of Cycle 1 and 2; Day 15 of Cycle 1; Day 1 of Cycles 3, 4, and 5 (each cycle is 28 days); after last BNA035 treatment (up to 1 year)
Area under the plasma concentration of BNA035
To evaluate the area under the curve (AUC) plasma-concentration after single and repeated IV weekly doses of BNA035
Measured: Days 1, 2, 3, 5, and 8 of Cycle 1 and 2; Day 15 of Cycle 1; Day 1 of Cycles 3, 4, and 5 (each cycle is 28 days); after last BNA035 treatment (up to 1 year)
Half-life of BNA035
To evaluate the half-life of BNA035 after single and repeated IV weekly doses
Measured: Days 1, 2, 3, 5, and 8 of Cycle 1 and 2; Day 15 of Cycle 1; Day 1 of Cycles 3, 4, and 5 (each cycle is 28 days); after last BNA035 treatment (up to 1 year)
Investigate immunogenicity of BNA035
Evaluated by the incidence and characteristics of anti-drug antibody (ADA) of BNA035
Measured: Day 1 of Cycle 1; Day 1 of every other Cycle thereafter (each cycle is 28 days); after last BNA035 treatment (up to 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start8 Feb 2022
- Primary completionNov 2023 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Sequential Assignment
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Binacea Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Josh Xiao, PhD, Study chair, Binacea Pharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150457
- Sponsor's protocol ID
- BNA035-101
- Status last verified
- Sep 2022
- First submitted
- 11 Nov 2021
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BNA035 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05150457
- Acronym / sponsor ID
- BNA035-101
- Conditions
- Refractory Solid Tumors
- Keywords
- Cancer, Advanced cancer, Recurrent cancer, Solid tumor, Metastatic cancer, Refractory cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Binacea Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 9 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the safety and tolerability of BNA035 in order to determine the maximum tolerated dose (MTD) and Recommended Phase 2 dose (RP2D) and to evaluate the preliminary efficacy for each combination regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Sequential Assignment
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Phase, Dose Level 1 | Experimental | Drug: BNA035Starting dose level of BNA035 administered as an IV infusion once weekly in 28 day cycles. Drug: BNA035 Administered once weekly as an IV infusion at the assigned dose level in 28 day cycles |
| Dose Escalation Phase, Dose Level 2 | Experimental | Drug: BNA0353 times the starting dose level of BNA035 administered as an IV infusion once weekly in 28 day cycles Drug: BNA035 Administered once weekly as an IV infusion at the assigned dose level in 28 day cycles |
| Dose Escalation Phase, Dose Level 3 | Experimental | Drug: BNA03510 times the starting dose level of BNA035 administered as an IV infusion once weekly in 28 day cycles Drug: BNA035 Administered once weekly as an IV infusion at the assigned dose level in 28 day cycles |
| Dose Escalation Phase, Dose Level 4 | Experimental | Drug: BNA03530 times the starting dose level of BNA035 administered as an IV infusion once weekly in 28 day cycles Drug: BNA035 Administered once weekly as an IV infusion at the assigned dose level in 28 day cycles |
| Dose Escalation Phase, Dose Level 5 | Experimental | Drug: BNA035100 times the starting dose level of BNA035 administered as an IV infusion once weekly in 28 day cycles Drug: BNA035 Administered once weekly as an IV infusion at the assigned dose level in 28 day cycles |
| Dose Escalation Phase, Dose Level 6 | Experimental | Drug: BNA035200 times the starting dose level of BNA035 administered as an IV infusion once weekly in 28 day cycles Drug: BNA035 Administered once weekly as an IV infusion at the assigned dose level in 28 day cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (34 listed)
- Patients must meet all of the following criteria to be eligible for enrollment in this study:
- Male or female ≥ 18 years of age.
- Histologically or cytologically confirmed advanced malignant solid tumor that is refractory to or intolerant of all standard therapy or for which no standard therapy is available.
- Measurable disease as per RECIST 1.1, or per Response Assessment in Neuro-Oncology (RANO) criteria for patients with glioblastoma multiforme and documented by computed tomography (CT) and/or magnetic resonance imaging (MRI).
- All persisting toxic effects of any prior anti-tumor therapy resolved to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 Grade ≤ 1 or baseline before the first dose of study drug (with the exception of alopecia [Grade 1 or 2 permitted] and neurotoxicity [Grade 1 or 2 permitted]).
Key exclusion criteria (26 listed)
- Pregnant or lactating or planning to become pregnant (self or partner) at any time during the study, including the Follow-up Period.
- History or evidence of clinically significant disorder, condition, or disease that, in the opinion of the Investigator or Medical Monitor, would pose a risk to patient safety or interfere with the study evaluations, procedures, or completion.
- History of ≥ Grade 3 AEs during prior treatment with an immune checkpoint inhibitor, or history of discontinuation of treatment with an immune checkpoint inhibitor due to AEs. Previous Grade 3 immune-related adverse events (irAEs) if not considered by the Investigator to increase the patient's risk for investigational product (IP) related AEs, may be approved on a case-by-case basis in discussion with the Sponsor (e.g., hypothyroidism on stable thyroxine replacement, adrenal insufficiency on stable hormone replacement therapy, diabetes on stable insulin therapy).
- Active or history of prior autoimmune disease with the exception of:
- The use of stable and controlled low dose steroids is acceptable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BNA035Anti-epidermal growth factor receptor (Anti-EGFR) and anti-cluster of differentiation 137 (anti-CD137) bispecific antibody | Drug | Dose Escalation Phase, Dose Level 1, Dose Escalation Phase, Dose Level 2, Dose Escalation Phase, Dose Level 3, Dose Escalation Phase, Dose Level 4, Dose Escalation Phase, Dose Level 5, Dose Escalation Phase, Dose Level 6 |
Primary outcome
Determination of the Maximum Tolerated Dose (MTD) Recommended Phase 2 Dose (RP2D) of BNA035 in patients with advanced solid tumors.
Time frame: From first dose of BNA035 (Cycle 1 Day 1) through the end of the DLT period (28 days from Cycle 1 Day 1)
Evaluated by the number of dose-limiting toxicities (DLT) graded using NCI CTCAE v 5.0
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: From first dose of BNA035 through 90 days after the last BNA035 dose)
To examine the incidence of clinical and laboratory adverse events after multiple doses of BNA035 in the dose escalation and dose expansion phases.
4 secondary outcomes
Peak Plasma Concentration of BNA035
Time frame: Days 1, 2, 3, 5, and 8 of Cycle 1 and 2; Day 15 of Cycle 1; Day 1 of Cycles 3, 4, and 5 (each cycle is 28 days); after last BNA035 treatment (up to 1 year)
Area under the plasma concentration of BNA035
Time frame: Days 1, 2, 3, 5, and 8 of Cycle 1 and 2; Day 15 of Cycle 1; Day 1 of Cycles 3, 4, and 5 (each cycle is 28 days); after last BNA035 treatment (up to 1 year)
Half-life of BNA035
Time frame: Days 1, 2, 3, 5, and 8 of Cycle 1 and 2; Day 15 of Cycle 1; Day 1 of Cycles 3, 4, and 5 (each cycle is 28 days); after last BNA035 treatment (up to 1 year)
Investigate immunogenicity of BNA035
Time frame: Day 1 of Cycle 1; Day 1 of every other Cycle thereafter (each cycle is 28 days); after last BNA035 treatment (up to 1 year)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josh Xiao, PhD study chair
Binacea Pharma, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BNA035 in people with Refractory Solid Tumors, run by Binacea Pharma, Inc. at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 34 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Josh Xiao, PhD (+1-650-773-8722, josh_xiao@binaceapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of the Maximum Tolerated Dose (MTD) Recommended Phase 2 Dose (RP2D) of BNA035 in patients with advanced solid tumors. (time frame: From first dose of BNA035 (Cycle 1 Day 1) through the end of the DLT period (28 days from Cycle 1 Day 1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2022.