A Phase 1/2 Study of SC-43 in Combination With Cisplatin

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Brief Title

A Phase 1/2 Study of SC-43 in Combination With Cisplatin

Official Title

A Phase 1/2, Open-label, Study to Investigate the Safety, Tolerability, and Efficacy of SC-43 Administered in Combination With Cisplatin in Subjects With Advanced or Refractory Non-small Cell Lung Cancer or Biliary Tract Carcinoma

Brief Summary

      SC-43 is STAT3 inhibitor. Based on the phase I data of SC-43 monotherapy, this is a Phase
      1/2, Open-label, Study to Investigate the Safety, Tolerability, and Efficacy of SC-43
      Administered in Combination with Cisplatin in Subjects with Advanced or Refractory Non-small
      Cell Lung Cancer or Biliary Tract Carcinoma
    

Detailed Description

      Based on the ongoing Phase 1 study in refractory cancer types, it is deemed adequate to
      select the starting dose at 50 mg in combination with cisplatin for NSCLC or BTC. The safety
      monitoring committee (SMC) will review the starting dose of 50 mg data and decide whether it
      is adequate to escalate the dose to 100, then 150 mg according to Bayesian optimal interval
      (BOIN) design. Moreover, based on the PK profiles and modelling, the loading dose 100 mg QD
      for 7 days will keep the minimal efficacy concentration and effectively maintain the p-STAT3
      level low enough to translate the anticancer efficacy with clinical efficacy for the study
      drug SC-43.

      The cisplatin efficacy for NSCLC and BTC, the chosen dose and dosing schedules 75 mg/m2 in a
      3-week cycle in combination with SC-43 are supported by previous clinical experience of
      observed efficacy and safety profiles for the indicated study populations.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Recommended phase 2 dose(RP2D) of SC-43

Secondary Outcome

 incidence of treatment-related adverse events as assessed by NCI-CTCAE v5.0

Condition

Advanced Non-small-cell Lung Cancer

Intervention

SC-43

Study Arms / Comparison Groups

 NSCLC
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

100

Start Date

May 1, 2021

Completion Date

September 30, 2023

Primary Completion Date

September 30, 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Life expectancy ≥ 12 weeks.

          -  Histologically or cytologically confirmed NSCLC or BTC.

          -  At least 1 measurable target lesion ≥ 10 mm as measured by MRI or CT according to
             RECIST v1.1-criteria. Target lesions within the field of prior efficacy irradiation or
             in the area of local treatment (intervention or ablation therapy) are considered
             measurable in case of confirmation of progression.

          -  Optional availability of archival or fresh tumor specimen that is suitable for
             analysis. Acceptable samples must have been acquired from a surgical operation, using
             core needle biopsy, or excisional biopsy. Samples that were acquired using fine needle
             aspiration are not acceptable. Archival samples from the primary or recurrent cancer
             will have been taken within 5 years prior to screening. formalin fixed,
             paraffin-embedded tumor

          -  Presence of all the following clinical laboratory findings at screening:

               -  Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L, or
                  hemoglobin ≥ 9 g/dL.

               -  Total bilirubin ≤ 1.5 × upper limit of normal (ULN) unless liver metastasis or
                  BTC in which case ≤ 2.5 × ULN is permitted at the investigator's discretion.

               -  For BTC subjects, alkaline phosphatase and gamma-glutamyl transferase ≤ 5 × ULN.

               -  Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN
                  unless disease (NSCLC with liver metastases or BTC) related, in which case ≤ 5 ×
                  ULN is permitted at the investigator's discretion.

               -  Creatinine ≤ 1.5 × ULN, or calculated or measured creatinine clearance (CrCl) ≥
                  60 mL/min as calculated by the Cockcroft-Gault method, or 24-hour measured urine
                  CrCl ≥ 50 mL/min.

          -  Eastern Cooperative Oncology Group performance status < 2.

          -  For subjects with chronic hepatitis B or C

          -  If a female subject or a female spouse/partner of male subject is of childbearing
             potential, she must agree to use highly effective contraceptives from signing informed
             consent to 28 days or 5 half-lives of SC-43, whichever is the longest, after the last
             dose of study drug administration

          -  Male subjects should be willing to use a condom (with spermicidal
             foam/gel/film/cream/suppository) to prevent pregnancy and exposure of a female partner
             and should refrain from donating sperm or fathering a child from signing informed
             consent to 90 days after the last dose of study drug administration.

          -  Able to comprehend and willing to sign an informed consent form (ICF)

        Exclusion Criteria:

          -  Clinically active or untreated central nervous system (CNS) metastases. Subjects with
             a history of treated CNS metastases that are asymptomatic are eligible.

          -  Malignancies other than NSCLC or BTC within 5 years prior to study enrollment, with
             the exception of those with a negligible risk of metastasis or death and treated with
             expected curative outcome (such as adequately treated carcinoma in situ of the cervix,
             basal or squamous cell skin cancer, localized prostate cancer treated with curative
             intent, or breast ductal carcinoma in situ treated surgically with curative intent).

          -  Any ≥ grade 2 (according to NCI-CTCAE v 5.0) AE at baseline (other than those
             previously allowed in the inclusion criteria).

          -  History of organ or tissue transplantation.

          -  History of autoimmune disease.

          -  Any serious acute, chronic infections that require systemic antimicrobial, antifungal,
             or antiviral therapy at screening, excluding viral hepatitis.

          -  History of human immunodeficiency virus infection.

          -  Significant cardiovascular disease, including:

               -  Heart disease classified as New York Heart Association class III or IV.

               -  Ongoing uncontrolled hypertension.

               -  History of congenital long QT syndrome.

               -  Ongoing prolonged QT interval corrected for heart rate using Fridericia's method
                  (QTcF) defined as ≥ 470 msec.

               -  History of serious ventricular arrhythmia (ie, ventricular tachycardia or
                  ventricular fibrillation).

               -  Subjects with atrial fibrillation, that is well controlled with treatment, can be
                  enrolled.

          -  Ascertained hypersensitivity to any ingredient of SC-43 or drugs with similar chemical
             structures, including sorafenib. If there is suspicion that the subject may have an
             allergy, the subject should be excluded.

          -  Uncontrolled nausea or vomiting or any symptom that would prevent the ability to
             comply with daily oral SC-43 treatment

          -  Significant gastrointestinal disorder(s) within 12 weeks prior to screening that
             would, in the opinion of the investigator, prevent absorption of an orally available
             agent

          -  Active bleeding during the last 4 weeks prior to screening or in the investigator's
             judgment, the existence of high bleeding tendency lesions such as active
             gastrointestinal ulcers or prominent esophageal or gastric varices.

          -  Requirement for ongoing immunosuppressive agents (including azathioprine,
             mycophenolate, cyclophosphamide, chlorambucil, methotrexate, cyclosporine), or
             systemic steroid with equivalent dosage higher than prednisolone 30 mg/day for more
             than 14 days.

          -  Received an investigational agent within 4 weeks prior to screening.

          -  Had previous anticancer therapy (surgery, radiotherapy, chemotherapy, targeted
             therapy, immunotherapy, biological therapy, or hormonal therapy) within 4 weeks (6
             weeks for nitrosoureas or mitomycin C) prior to the first dose of SC-43
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

In-Jae Oh, MD, 82 70 7005 6875, [email protected]



Administrative Informations


NCT ID

NCT04733521

Organization ID

RB-SCR-01


Responsible Party

Sponsor

Study Sponsor

RaND Biosciences


Study Sponsor

In-Jae Oh, MD, Principal Investigator, Chonnam National University


Verification Date

January 2021