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

NCT04733521 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: RB-SCR-01
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Conditions

Advanced Non-small-cell Lung Cancer; Advanced Biliary Tract Cancer

Outcome Measures

Primary Outcomes (2)

• Recommended phase 2 dose(RP2D) of SC-43

  to determine a RP2D of SC-43 for each population of non-small cell lung cancer and biliary tract carcinoma subjects

  18 weeks

• preliminary antitumor activity of SC-43

  the preliminary antitumor activity of SC-43 in combination with other anticancer agents as measured by overall response rate (ORR) according to standard criteria (Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\])

  18 weeks

Secondary Outcomes (8)

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

  18 weeks

• Maximum plasma concentration (Cmax)

  day 1 of cycle 1, day 1 of cycle 2 (each 21-day cycle)

• Area under the plasma concentration versus time curve (AUC)

  day 1 of cycle 1, day 1 of cycle 2 (each 21-day cycle)

• Objective response rate (ORR) according to RECIST criteria version 1.1

  18 weeks

• Disease control rate (DCR) according to RECIST criteria version 1.1

  18 weeks

Other Outcomes (1)

• phosphorylated signal transducer and activator of transcription 3(p-STAT3) status in peripheral blood mononuclear cells (PBMCs) of subjects

  day -14 to -1(prior to dosing), day 1 of cycle 2 and cycle 3, and end of treatment (each 21-day cycle)

Study Arms (2)

NSCLC

EXPERIMENTAL

Drug: SC-43; Drug: Cisplatin

BTC

EXPERIMENTAL

Drug: SC-43; Drug: Cisplatin

Interventions

SC-43 DRUG

SC-43 oral, every day of 21-day cycle

BTC; NSCLC

Cisplatin DRUG

cisplatin 75mg/m2 on day 1 of 21-day cycle

BTC; NSCLC

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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).
• 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

Sponsors & Collaborators

• RaND Biosciences: lead

MeSH Terms

Interventions

Cisplatin

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• In-Jae Oh, MD

  Chonnam National University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chief Clinical Officer

CONTACT

82 70 7005 6875; ahn@randbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: February 2, 2021
• Study Start: May 1, 2021
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: February 2, 2021

Record last verified: 2021-01