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A Phase 1 Dose Escalation Study of SCB01A in Subjects With Advanced Solid Tumors Who Have Failed Standard Therapy

Phase 1
18 Years
Open (Enrolling)
Solid Tumors

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Trial Information

A Phase 1 Dose Escalation Study of SCB01A in Subjects With Advanced Solid Tumors Who Have Failed Standard Therapy

This is an open-label, single-arm, dose-escalation, safety and tolerability study. Eligible
subjects will be assigned to a SCB01A dose level at the time of study entry and scheduled to
receive two treatment cycles with SCB01A for the observation of DLT. A treatment cycle is
defined as a three-hour infusion of SCB01A given every 21 days. Unless any off-study
criteria are met, the study period of each subject can be up to two cycles.

Inclusion Criteria:

1. Subjects who are at least 18 years of age.

2. Have provided written informed consent prior to the initiation of study procedures.

3. Have histologically or cytologically confirmed diagnosis of an advanced solid tumor
that has failed to respond to all available standard treatments.

4. Have ECOG PS scale of 0-1 at the time of enrollment.

5. Have adequate organ function:

1. Bone marrow function:

- White blood cell count (WBC) ≥ 4000/μL

- Absolute neutrophil count (ANC) ≥ 1500/μL

- Hemoglobin ≥ 10.0 g/dL

- Platelet count ≥ 100,000/μL

2. Hepatic Function:

- Serum total bilirubin level ≤ 1.0 x upper normal limit

- Serum alanine aminotransferase (ALT) level ≤ 2.5 x upper normal limit

3. Renal Function:

• Serum creatinine ≤ 1.0 x upper normal limit and creatinine clearance
(estimated by Cockcroft-Gault formula) > 60 mL/min

4. Heart Function:

- Ejection fraction ≥ 55%

- QTC < 450 msec

6. Have a life expectancy of at least 3 months

7. Have negative serum pregnancy test within 1 week before study drug administration
(for women of childbearing potential and not diagnosed as germ cell tumor with
beta-HCG only).

8. Are willing to practice medically accepted contraception (if the risk of
contraception exists) throughout the study period (from screening until Final Visit).

Exclusion Criteria:

1. Subjects who have failed to recover from prior anti-cancer treatment-related
toxicities, e.g. surgery, chemotherapy, radiotherapy, target therapy, biologic
therapy, immunotherapy, alternative medicine, hormonal therapy, or investigational

2. Treatment with an investigational drug, chemotherapy, targeting agent(s), biologic
therapy (e.g., IL-2, Interferon, etc.), immunotherapy (e.g. tumor vaccine, etc.),
alternative medicine or hormonal therapy (e.g. anti-estrogens, anti-androgens, etc.),
radiation (except to bone) or surgery (except exploratory biopsy or intravenous
device implantation, etc.) within 28 days prior to study entry.

3. Grade 2 or higher sensory neuropathy of any etiology.

4. Subjects with severe cardiopulmonary diseases (including history of stable,
effort-induced or unstable angina pectoris, myocardial infarction, or arrhythmia) or
other systemic diseases under poor control.

5. Females who are pregnant, lactating, or have a positive serum pregnancy test except
those are diagnosed as germ cell tumor with beta-HCG prior to study treatment.
Pre-menopausal women who are not abstinent must prove surgical sterility or
compliance with a contraceptive regimen. Male subjects and male partners of female
subjects must be abstinent, surgically sterile, or utilizing a barrier contraceptive

6. Tumor with central nervous system (CNS) involvement.

7. Subjects with concomitant active 2nd primary malignancies or disease-free for no more
than 3 years following a definitive therapy for prior metachronous malignancies,
except for surgically cured carcinoma, i.e. in situ of the cervix or adequately
treated basal cell carcinoma of the skin or Dukes' A colorectal cancer.

8. Known history of allergy to any component of this investigational preparation.

9. History of exposure to SCB01A or its analogs.

10. Active infection requiring antibiotic therapy at time of study entry.

11. Is unwilling or unable to comply with the protocol requirements.

12. Known human immunodeficiency virus (HIV) infection.

13. History of receiving organ transplantation or immunologic illness that require
continuous immunosuppressant agent therapy.

14. Have other medical or psychological conditions that would not permit the study
participant to complete the study or sign informed consent.

15. Have any other disease, dysfunction, alcohol or drug abuse, physical examination or
lab finding that, in the investigator's opinion, would exclude the subject from the

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum tolerated dose (MTD)in subjects with advanced solid tumor

Outcome Description:

MTD is the dose at which atleast two subjects experience the DLT; and DLT is defined as Grade 3 or greater Neutropenia, Thrombocytopenia, prolonged QTc, non-hematological adverse events and neurotoxicity

Outcome Time Frame:

Each subject can be given up to 2 cycles of SCB01A. Each cycle will be 21 days.

Safety Issue:


Principal Investigator

Muh-Hwan Su, Ph.D.

Investigator Role:

Study Director

Investigator Affiliation:

SynCore Biotechnology


United States: Food and Drug Administration

Study ID:




Start Date:

April 2011

Completion Date:

December 2013

Related Keywords:

  • Solid Tumors
  • Advanced Solid Tumors Who Have Failed Standard Therapy
  • Neoplasms