Safety and Efficacy of DCB-BO1301 in Advanced Melanoma

NCT02994498 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: CMB-B01
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary study objectives are

1. 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. 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)

Conditions

Advanced Melanoma

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose

  Week 6

Secondary Outcomes (5)

• Incidence of adverse events

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

• Response rate

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

• Overall survival

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

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

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

• Progression free survival

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

Study Arms (3)

DCB-BO1301 1 capsule

EXPERIMENTAL

DCB-BO1301 1 capsule, tid (around 1 hour before meal) for at most 48 weeks

Drug: DCB-BO1301

DCB-BO1301 2 capsules

EXPERIMENTAL

DCB-BO1301 2 capsules, tid (around 1 hour before meal) for at most 48 weeks

Drug: DCB-BO1301

DCB-BO1301 3 capsules

EXPERIMENTAL

DCB-BO1301 3 capsules, tid (around 1 hour before meal) for at most 48 weeks

Drug: DCB-BO1301

Interventions

DCB-BO1301 DRUG

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

DCB-BO1301 1 capsule; DCB-BO1301 2 capsules; DCB-BO1301 3 capsules

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• 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,
• d. 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

Sponsors & Collaborators

• Chung Mei Biopharma Co., Ltd: lead

Central Study Contacts

Leon YZ Zhan, MS

CONTACT

+886-4-2329-0578; Leon.Zhan@cm-biopha.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2016
• First Posted: December 16, 2016
• Study Start: March 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 18, 2022

Record last verified: 2022-03