Advanced Solid TumorsPhase 1NCT03256331
Evaluate the Safety of BEL-X-HG in Advanced Cancer Patients
A Phase 1 study testing BEL-X-HG in people with Advanced Solid Tumors, run by Belx Bio-Pharmaceutical (Taiwan) Corporation at 2 sites in Taiwan.
Trial summary
This is a Phase I, open-label, uncontrolled, multicenter dose escalation and extension study to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate safety / tolerability and preliminary effects of BEL-X-HG in patients with advanced refractory solid tumors. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- BEL-X-HG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesTaiwan
- Study dates
- 21 Jun 2017to 30 Mar 2020
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients of age ≥20 years
- Pathologically or cytologically confirmed advanced refractory solid tumors for which standard therapy proven to provide clinical benefit does not exist or is no longer effective. It is acceptable for HCC subjects with Child Pugh stage A to confirm diagnosis of the advanced refractory solid tumors by imaging (CT scan).
- Evaluable disease, at least one measurable target lesion on imaging by RECIST 1.1 (Response Evaluation Criteria in Solid Tumors) criteria.
- Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2
- Life expectancy ≥ 3 months
- Patients able to swallow and retain orally administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major restriction of the stomach or bowels
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- Laboratory values at screening and baseline (Day 1) of:
- Absolute neutrophil count (ANC) ≥ 1,500 /mm3
- Platelets ≥ 75,000 /mm3
- Hemoglobin (Hb) ≥ 8.5 g/dL
- Serum creatinine (Cr.) ≤1.5 mg/dL or estimated Glomerular Filtration Rate (eGFR) ≥ 60 mL/min/1.73 m2.
- MDRD Study equation: eGFR = 186 x (SCr)^-1.154 x (age)^0.203 x (0.742 if female) x (1.210 if African American) SCr: serum creatinine in mg/dL; age: in year
- Patients with primary liver cancer or hepatic metastasis are eligible to enroll, provided that, at screening and baseline (Day 1), the following criteria are met:
- Total bilirubin (T-Bil) ≤2.0 mg/dL
- AST and ALT ≤ 5 times the institutional upper limit of normal
- Child-Pugh Class A; (Score ≤6)
- Serum albumin ≥2.8 g/dL
- Patients with a history of esophageal bleeding have varices that have been sclerosed or banded and no bleeding episodes have occurred during the prior 6 months
- If history of brain metastases treated with radiation therapy, radiation therapy is required to be completed at least 3 months prior to enrolment and metastasis achieve stable disease (SD) since radiation completion
- Must have recovered from toxicities of previous anti-cancer treatments to NCI-CTCAE version 4.03 grade 1 or lower, except for alopecia
- Females patient must be either of non-childbearing potential, i.e. surgically sterilized (e.g. tubal ligation, hysterectomy, or ovariectomy) or one year post- menopausal; or, if of childbearing potential, confirmed not pregnant at screening and use of two adequate contraceptive precautions (as per investigator) i.e. condoms plus oral contraceptives or condoms plus endometrial contraceptive devices, during the entire treatment period of this study and for 6 months after exiting from the study
- Male patients with female partners of childbearing potential must be willing to use a reliable form of contraception (condoms), from screening until 6 months after existing from the study
- Given signed and dated written informed consent and willing/able to comply with all protocol required visits/procedures
Who cannot join
- Primary major surgery < 4 weeks prior to the planned first study treatment day
- Lactating or pregnant women or plans to be become pregnant
- Except for alopecia, any drug-related AE from any previous treatments not recovered to NCI-CTCAE version 4.03 grade 1 or lower prior to the planned first study treatment day
- With active systemic infections, active and clinically significant cardiac diseases, active gastrointestinal diseases, active pulmonary diseases, or medical conditions that may significantly affect adequate absorption of investigational product.
- Known allergy to BEL-X-HG or its formulation excipients
- History of autoimmune disease that in the investigator's opinion may be significant to exclude participation in the study
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- Use of any investigational agents or non-registered product within 4 weeks of baseline
- Known human immunodeficiency virus (HIV) positivity
- Known hepatitis B virus (HBV) or hepatitis C virus (HCV) carrier who has:
- serum HBV DNA > 2,000 IU/mL and abnormal ALT (> 5 ULN) (for HBV carrier)
- abnormal ALT (> 5 ULN) (for HCV carrier)
- With conditions, judged by the investigator, as unsuitable for the study
- Mean QTc with Fridericia's correction (QTcF*) greater than 450 ms in screening ECG or history of familial long QT syndrome
- : Fridericia's formula:
- Any cancer-directed therapy (chemotherapy, radiotherapy, biological or immunotherapy, etc.) within 4 weeks or 5 half-lives, (whichever is shorter) of baseline
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
National Cheng Kung University Hospital
Tainan, 704
National Taiwan University Hospital
Taipei, 100
About this study
Official title: A Phase I, Open-Label, Dose Escalation and Extension Study to Evaluate the Safety, Tolerability and Preliminary Effects of Oral BEL-X-HG in Patients With Advanced Refractory Solid Malignancies
This is a Phase I, open-label, uncontrolled, multicenter dose escalation and extension study to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate safety / tolerability and preliminary effects of BEL-X-HG in patients with advanced refractory solid tumors. Dose escalation during the study will be made based on dose-limiting toxicity (DLT).
Read the detailed description
This study will be carried out in 2 parts:
Part 1: A sequential Dose Escalation Part of four doses following a 3 + 3 design where dose escalation will be made based on dose-limiting toxicity (DLT), for a single cycle (28-days) of BEL-X-HG treatment
Part 2: A Dose Extension Part of up to 5 cycles (28-days each) at the same dose level (starting dose) of BEL-X-HG treatment
Approximately 24-48 eligible subjects with confirmed advanced refractory solid tumors will be enrolled sequentially, in 3 subject cohorts, from the lower to the higher dose cohort into the study. Escalating dose levels of BEL-X-HG in 4 study cohorts and one modified dose will be as follows:
Cohort 1: Dose level 1 - 0.5 g/day (0.25 g, bid)
Cohort 2: Dose level 2 - 1.0 g/day (0.5 g, bid)
Cohort 3: Dose level 3 - 2.0 g/day (1.0 g, bid)
Cohort 4: Dose level 4 - 4.0 g/day (2.0 g, bid)
Modified dose level Cohort 5: Dose level 5 - 1.5 g/day (0.75g bid) This re-escalation is allowed only when dose de-escalates from Dose level 3 to Dose level 2, and 1 DLT in 6 evaluable subjects of Dose level 2.
BEL-X-HG will be administered orally at the assigned dose level for a single cycle consisting of 28 days during the Dose Escalation Part to each subject. Thereafter, if eligible and willing, subjects can continue to Extension Part for 5 more cycles of treatment (each cycle lasting 28 days), at the same assigned dose level of BEL-X-HG treatment.
- Conditions
- Advanced Solid Tumors
- Being tested
- BEL-X-HG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEL-X-HGDrug
This study will be carried out in 2 parts:
- A sequential Dose Escalation Part of four doses following a 3 + 3 design where dose escalation will be made based on DLT, for a single cycle (28 days) of BEL-X-HG treatment
- A Dose Extension Part of up to 5 cycles (28 days each) at the same dose level (starting dose) of BEL-X-HG treatment
Escalating dose levels of BEL-X-HG in 5 study cohorts and one modified dose will be as follows:
- Cohort 1: Dose level 1 - 0.5 g/day (0.25 g, bid)
- Cohort 2: Dose level 2 - 1.0 g/day (0.5 g, bid)
- Cohort 3: Dose level 3 - 2.0 g/day (1.0 g, bid)
- Cohort 4: Dose level 4 - 4.0 g/day (2.0 g, bid) Modified dose level Cohort 5: Dose level 5 - 1.5 g/day (0.75g bid) This re-escalation is allowed only when dose de-escalates from Dose level 3 to Dose level 2, and 1 DLT in 6 evaluable subjects of Dose level 2.
| Study group | Role | What they receive |
|---|---|---|
| BEL-X-HG | Experimental | 3+3 dose escalation Receives: Drug: BEL-X-HG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
The prior dose level below the dose level at which ≥2/3 or ≥2/6 subjects suffer dose-limiting toxicity (DLT).
Measured: 28 days (first treatment cycle of every subjects)
Secondary outcomes (8)
Incidence of Treatment-Emergent Adverse Events
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: up to 168 days (up to 6 cycles of each enrolled subjects)
Tumor response per Response Evaluation Criteria in Solid Tumors (RECIST)
Tumor response per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Measured: up to 168 days (up to 6 cycles of each enrolled subjects)
Oxidative stress
Oxidative stress
Measured: up to 168 days (up to 6 cycles of each enrolled subjects)
nutritional status
serum prealbumin, triglyceride, and total cholesterol
Measured: up to 168 days (up to 6 cycles of each enrolled subjects)
immunological status
TNF-alpha, IL-1, IL-2, IL-4, and IL-6
Measured: up to 168 days (up to 6 cycles of each enrolled subjects)
cachexia status
fast blood glucose, C-reactive protein, and testosteron
Measured: up to 168 days (up to 6 cycles of each enrolled subjects)
Quality of life (QoL) of patients with advanced refractory solid tumors
SF-36 Quality of Life (QoL) Questionnaire
Measured: up to 168 days (up to 6 cycles of each enrolled subjects)
liver function
serum AST, ALT, AKP, albumin, gamma-GT, ferritin, PT/INR and APRI
Measured: up to 168 days (up to 6 cycles of each enrolled subjects)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start21 Jun 2017
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Why it stopped: In the light of the on-going COVID-19 pandemic and the resulted difficulty in patient recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- Intervention model
- Sequential
- Model description
- A sequential Dose Escalation Part of four doses following a 3 + 3 design.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Belx Bio-Pharmaceutical (Taiwan) Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- A2 Healthcare Taiwan Corporation
- Responsible party
- Sponsor
- Investigators
- Chia-Chi Lin, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03256331
- Sponsor's protocol ID
- BELXHG-SP001
- Status last verified
- May 2020
- First submitted
- 13 Aug 2017
- Last updated
- 1 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Dose Escalation and Extension Study to Evaluate the Safety, Tolerability and Preliminary Effects of Oral BEL-X-HG in Patients With Advanced Refractory Solid Malignancies
- ClinicalTrials.gov ID
- NCT03256331
- Acronym / sponsor ID
- BELXHG-SP001
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: In the light of the on-going COVID-19 pandemic and the resulted difficulty in patient recruitment.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Belx Bio-Pharmaceutical (Taiwan) CorporationIndustry (pharma, biotech, devices)
- Collaborators
- A2 Healthcare Taiwan Corporation
- Study start
- 21 Jun 2017 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 22 Aug 2017 (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.
This is a Phase I, open-label, uncontrolled, multicenter dose escalation and extension study to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate safety / tolerability and preliminary effects of BEL-X-HG in patients with advanced refractory solid tumors. Dose escalation during the study will be made based on dose-limiting toxicity (DLT).
Detailed description
This study will be carried out in 2 parts:
Part 1: A sequential Dose Escalation Part of four doses following a 3 + 3 design where dose escalation will be made based on dose-limiting toxicity (DLT), for a single cycle (28-days) of BEL-X-HG treatment
Part 2: A Dose Extension Part of up to 5 cycles (28-days each) at the same dose level (starting dose) of BEL-X-HG treatment
Approximately 24-48 eligible subjects with confirmed advanced refractory solid tumors will be enrolled sequentially, in 3 subject cohorts, from the lower to the higher dose cohort into the study. Escalating dose levels of BEL-X-HG in 4 study cohorts and one modified dose will be as follows:
Cohort 1: Dose level 1 - 0.5 g/day (0.25 g, bid)
Cohort 2: Dose level 2 - 1.0 g/day (0.5 g, bid)
Cohort 3: Dose level 3 - 2.0 g/day (1.0 g, bid)
Cohort 4: Dose level 4 - 4.0 g/day (2.0 g, bid)
Modified dose level Cohort 5: Dose level 5 - 1.5 g/day (0.75g bid) This re-escalation is allowed only when dose de-escalates from Dose level 3 to Dose level 2, and 1 DLT in 6 evaluable subjects of Dose level 2.
BEL-X-HG will be administered orally at the assigned dose level for a single cycle consisting of 28 days during the Dose Escalation Part to each subject. Thereafter, if eligible and willing, subjects can continue to Extension Part for 5 more cycles of treatment (each cycle lasting 28 days), at the same assigned dose level of BEL-X-HG treatment.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A sequential Dose Escalation Part of four doses following a 3 + 3 design.
| Arm | Type | Receives |
|---|---|---|
| BEL-X-HG | Experimental | Drug: BEL-X-HG3+3 dose escalation |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Male or female patients of age ≥20 years
- Pathologically or cytologically confirmed advanced refractory solid tumors for which standard therapy proven to provide clinical benefit does not exist or is no longer effective. It is acceptable for HCC subjects with Child Pugh stage A to confirm diagnosis of the advanced refractory solid tumors by imaging (CT scan).
- Evaluable disease, at least one measurable target lesion on imaging by RECIST 1.1 (Response Evaluation Criteria in Solid Tumors) criteria.
- Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2
- Life expectancy ≥ 3 months
Key exclusion criteria (15 listed)
- Primary major surgery < 4 weeks prior to the planned first study treatment day
- Lactating or pregnant women or plans to be become pregnant
- Except for alopecia, any drug-related AE from any previous treatments not recovered to NCI-CTCAE version 4.03 grade 1 or lower prior to the planned first study treatment day
- With active systemic infections, active and clinically significant cardiac diseases, active gastrointestinal diseases, active pulmonary diseases, or medical conditions that may significantly affect adequate absorption of investigational product.
- Known allergy to BEL-X-HG or its formulation excipients
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 |
|---|---|---|
| BEL-X-HGThis study will be carried out in 2 parts: 1. A sequential Dose Escalation Part of four doses following a 3 + 3 design where dose escalation will be made based on DLT, for a single cycle (28 days) of BEL-X-HG treatment 2. A Dose Extension Part of up to 5 cycles (28 days each) at the same dose level (starting dose) of BEL-X-HG treatment Escalating dose levels of BEL-X-HG in 5 study cohorts and one modified dose will be as follows: * Cohort 1: Dose level 1 - 0.5 g/day (0.25 g, bid) * Cohort 2: Dose level 2 - 1.0 g/day (0.5 g, bid) * Cohort 3: Dose level 3 - 2.0 g/day (1.0 g, bid) * Cohort 4: Dose level 4 - 4.0 g/day (2.0 g, bid) Modified dose level Cohort 5: Dose level 5 - 1.5 g/day (0.75g bid) This re-escalation is allowed only when dose de-escalates from Dose level 3 to Dose level 2, and 1 DLT in 6 evaluable subjects of Dose level 2. | Drug | BEL-X-HG |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: 28 days (first treatment cycle of every subjects)
The prior dose level below the dose level at which ≥2/3 or ≥2/6 subjects suffer dose-limiting toxicity (DLT).
8 secondary outcomes
Incidence of Treatment-Emergent Adverse Events
Time frame: up to 168 days (up to 6 cycles of each enrolled subjects)
Tumor response per Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: up to 168 days (up to 6 cycles of each enrolled subjects)
Oxidative stress
Time frame: up to 168 days (up to 6 cycles of each enrolled subjects)
nutritional status
Time frame: up to 168 days (up to 6 cycles of each enrolled subjects)
immunological status
Time frame: up to 168 days (up to 6 cycles of each enrolled subjects)
cachexia status
Time frame: up to 168 days (up to 6 cycles of each enrolled subjects)
Quality of life (QoL) of patients with advanced refractory solid tumors
Time frame: up to 168 days (up to 6 cycles of each enrolled subjects)
liver function
Time frame: up to 168 days (up to 6 cycles of each enrolled subjects)
Results and safety
The study was stopped early (reason given: In the light of the on-going COVID-19 pandemic and the resulted difficulty in patient recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
- Individual participant dataSharing planned: No
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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.
Chia-Chi Lin, MD, PhD principal investigator
National Taiwan University Hospital
2 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 BEL-X-HG in people with Advanced Solid Tumors, run by Belx Bio-Pharmaceutical (Taiwan) Corporation at 2 sites in Taiwan.
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 23 inclusion and 15 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: stopped early, as of the sponsor's last update on 1 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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?
The study was stopped early (reason given: In the light of the on-going COVID-19 pandemic and the resulted difficulty in patient recruitment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) (time frame: 28 days (first treatment cycle of every subjects)). 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 1 Jun 2020.