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Advanced MelanomaPhase 1/2NCT02994498

Safety and Efficacy of DCB-BO1301 in Advanced Melanoma

A Phase 1/2 study testing DCB-BO1301 in people with Advanced Melanoma, run by Chung Mei Biopharma Co., Ltd.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The primary study objectives are 1. to evaluate the safety and tolerability profiles of DCB-BO1301 and to determine the maximum tolerated dose (MTD) of DCB-BO1301 as add-on therapy to dacarbazine in subjects with advanced melanoma (Phase I) 2. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Advanced Melanoma
What is being tested?
DCB-BO1301
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
No sites listed yet
Study dates
Mar 2023to Dec 2025
Phase
Phase 1/2
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects ≧ 20 years old (inclusive)
  • Histologically or cytologically confirmed advanced melanoma, (stage III or IV)
  • Subject must have at least one of the following:
  • Melanoma that was previously treated with at least one complete or partial course of therapy for melanoma with either a poor to no response or evidence of disease progression;
  • Melanoma that cannot be treated with first-line therapies because of medical comorbidities/risk of toxicity; or
  • Melanoma that has not been treated with first-line therapies because of patient refusal.
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  • If melanoma is possibly resectable, the melanoma must have recurred despite at least two attempts at resection.
  • Evaluable disease, at least one measurable target lesion on imaging by RECIST 1.1 criteria on previous scan
  • ECOG performance status ≤ 2 and life expectancy ≥ 3 months Note: ECOG = Eastern Cooperative Oncology Group
  • Females subjects must be either
  • of non-childbearing potential:
  • Or, if of childbearing potential:
  • Must have a negative urine or serum pregnancy test at screening, and
  • If heterosexually active, must use at least 1 form of birth control (which must be a barrier method) starting at screening and through the primary study period.
  • Female subject must not be breastfeeding at screening, through the treatment period and through the primary study period.
  • Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control (1 of which must be a barrier method) starting at screening, through the treatment period and through the primary study period.
  • Dated and signed informed consent

Who cannot join

  • Primary CNS malignancies or clinically active CNS metastases
  • Ascertained hypersensitivity to any component of investigational product or standard therapies that the subject will be treated
  • Any of the following hematologic abnormalities:
  • Hemoglobin < 10 g/dL,
  • ANC < 1,500/μL,
  • Platelets < 75,000 /μL Note: ANC = absolute neutrophil count
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  • Any of the following serum chemistry abnormalities:
  • Total bilirubin > 1.5 × ULN,
  • AST, ALT, or Alk-P > 2.5 × ULN,
  • serum albumin < 2.5 g/dL,
  • creatinine > 1.5 × ULN,
  • creatine phosphokinase (CPK) > 2.5 × ULN,
  • any other ≥ Grade 3 laboratory abnormality at baseline (other than those listed above) Note: ULN = upper limit of normal. AST = aspartate transaminase, ALT = alanine transaminase
  • History of known brain metastases
  • Anticipated requiring, being taking, or taken with past 2 weeks of Screening visit of systemic steroid, immunosuppressive agents, aspirin (more than 100 mg/day), NSAID (except COX-2 Inhibitors), heparin, low molecular weight heparin or warfarin (more than 1 mg/day) Note: NSAID = Nonsteroidal anti-inflammatory drugs
  • Uncontrolled nausea or vomiting or any symptom that would prevent the ability to comply with daily oral DCB-BO1301 treatment
  • Serious/active infection such as HIV, HBV or HCV carrier, or infection requiring parenteral antibiotics Note: HIV = Human immunodeficiency virus; HBV = Hepatitis B virus; HCV = hepatitis C virus
  • Uncontrolled psychiatric disorder or altered mental status precluding informed consent or necessary testing
  • Consumption of herbal preparations/supplements (except for a daily multivitamin/mineral supplement not containing herbal components) within 2 weeks prior to the start of DCB-BO1301 administration
  • Significant cardiovascular disease, including:
  • Active clinically symptomatic left ventricular failure
  • Active hypertension (diastolic blood pressure > 100 mmHg). Subjects with a history of hypertension must have been on stable doses of anti-hypertensive drugs for ≥ 4 weeks prior to start of DCB-BO1301 administration
  • Uncontrolled hypertension: Blood pressure >140/90 mmHg on more than 2 antihypertensive medications
  • Myocardial infarction within 3 months prior to the start of DCB-BO1301 administration
  • Prothrombin time > 1.5 x ULN; APTT abnormal (< 20 sec or > 34 sec) ; long QT syndrome
  • Significant gastrointestinal disorder(s) that would, in the opinion of the investigator, prevent absorption of an orally available agent
  • Has received an investigational agent within 4 weeks of entering this study
  • With any condition judged by the investigator that entering the trial may be detrimental to the subject
  • Receiving chemotherapy, investigational or hormonal therapy, major surgeries in the previous 4 weeks of Screening visit.

Trial locations and contacts

No sites are listed yet.

Leon YZ Zhan, MS contact

+886-4-2329-0578 ext. 511

Leon.Zhan@cm-biopha.com

About this study

Official title: An Open-Label Phase I/IIa Dose-Escalation Study Evaluating the Safety, Tolerability and Efficacy of DCB-BO1301 as Add-on Therapy to Dacarbazine in Subjects With Advanced Melanoma

The primary study objectives are

  1. to evaluate the safety and tolerability profiles of DCB-BO1301 and to determine the maximum tolerated dose (MTD) of DCB-BO1301 as add-on therapy to dacarbazine in subjects with advanced melanoma (Phase I)
  2. to evaluate the efficacy profile of DCB-BO1301 at MTD or lower dose level as add-on therapy to dacarbazine in subjects with advanced melanoma in terms of progression free survival (Phase IIa)
Being tested
DCB-BO1301

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DCB-BO1301Drug

    1, 2, or 3 capsules, three times a day, oral, at most 48 weeks

Study groups in NCT02994498
Study groupRoleWhat they receive
DCB-BO1301 1 capsuleExperimentalDCB-BO1301 1 capsule, tid (around 1 hour before meal) for at most 48 weeks
Receives: Drug: DCB-BO1301
DCB-BO1301 2 capsulesExperimentalDCB-BO1301 2 capsules, tid (around 1 hour before meal) for at most 48 weeks
Receives: Drug: DCB-BO1301
DCB-BO1301 3 capsulesExperimentalDCB-BO1301 3 capsules, tid (around 1 hour before meal) for at most 48 weeks
Receives: Drug: DCB-BO1301

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose

    Measured: Week 6

Secondary outcomes (5)

  1. Incidence of adverse events

    Measured: Weeks 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 52

  2. Response rate

    Measured: Weeks 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 52

  3. Overall survival

    Measured: Weeks 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 52, 64, 76

  4. Changes in global health/QoL standardized score at post-treatment visits compared to baseline.

    Measured: Weeks 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 52

  5. Progression free survival

    Measured: Weeks 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 52, 64,76

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2016 (estimated)
  2. Study startMar 2023 (estimated)
  3. Primary completionSep 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
33 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02994498
Sponsor's protocol ID
CMB-B01
Status last verified
Mar 2022
First submitted
9 Dec 2016
Last updated
18 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing DCB-BO1301 in people with Advanced Melanoma, run by Chung Mei Biopharma Co., Ltd.

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 17 inclusion and 29 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 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Leon YZ Zhan, MS (+886-4-2329-0578 ext. 511, Leon.Zhan@cm-biopha.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (time frame: Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02994498.

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 18 Mar 2022.

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