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Advanced Non-small-cell Lung CancerPhase 1/2NCT04733521

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

A Phase 1/2 study testing SC-43 and Cisplatin in people with Advanced Non-small-cell Lung Cancer and Advanced Biliary Tract Cancer, run by RaND Biosciences.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SC-43 and Cisplatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
1 May 2021to 30 Sep 2023
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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)

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

No sites are listed yet.

Chief Clinical Officer contact

82 70 7005 6875

ahn@randbio.com

About this study

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

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

Read the 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.

Being tested
SC-43, Cisplatin

What participants receive

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

  • SC-43Drug

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

  • CisplatinDrug

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

Study groups in NCT04733521
Study groupRoleWhat they receive
NSCLCExperimentalNot described
Receives: Drug: SC-43; Drug: Cisplatin
BTCExperimentalNot described
Receives: Drug: SC-43; Drug: Cisplatin

What is being measured

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

  1. 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

    Measured: 18 weeks

  2. 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])

    Measured: 18 weeks

Secondary outcomes (8)

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

    incidence of treatment-related adverse events in combination with cisplatin in subjects with non-small cell lung cancer and biliary tract carcinoma. All adverse events will be assessed for severity based on NCI-CTCAE version 5.0

    Measured: 18 weeks

  2. Maximum plasma concentration (Cmax)

    PK blood samples will be collected at predefined time intervals, and the maximum plasma concentration will be determined.

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

  3. Area under the plasma concentration versus time curve (AUC)

    PK blood samples will be collected at predefined time intervals, and the AUC from time 0 to the last time point will be calculated.

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

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

    Objective response rate (ORR) is defined as the proportion of subjects with complete response (CR) or partial response (PR) as best overall response evaluated according to RECIST criteria version 1.1 on MRI or CT results

    Measured: 18 weeks

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

    Disease control rate (DCR) is defined as the proportion of subjects with complete response (CR), partial response (PR), or stable disease (SD) as best overall response evaluated according to RECIST criteria version 1.1 on MRI or CT results.

    Measured: 18 weeks

  6. Duration of response(DOR) according to RECIST criteria version 1.1

    Duration of response(DOR) is defined as the time between the date of first response and the date of disease progression.

    Measured: 18 weeks

  7. Progression free survival(PFS) according to RECIST criteria version 1.1

    progression free survival(PFS) is defined as the time between the date of first dose of SC-43 and the date of progression or death, whichever occurs first

    Measured: 18 weeks

  8. overall survival(OS) according to RECIST criteria version 1.1

    overall survival(OS) time is defined as the length of time from the first dose of SC-43 to the date of death, regardless of the cause of death

    Measured: 18 weeks

Timeline

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

  1. First posted2 Feb 2021
  2. Study start1 May 2021 (estimated)
  3. Primary completion30 Sep 2023 (estimated)
  4. Study completion30 Sep 2023 (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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04733521
Sponsor's protocol ID
RB-SCR-01
Status last verified
Jan 2021
First submitted
25 Jan 2021
Last updated
2 Feb 2021
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 SC-43 and Cisplatin in people with Advanced Non-small-cell Lung Cancer and Advanced Biliary Tract Cancer, run by RaND Biosciences.

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 15 inclusion and 21 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 2 Feb 2021. 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 Chief Clinical Officer (82 70 7005 6875, ahn@randbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended phase 2 dose(RP2D) of SC-43 (time frame: 18 weeks). The study lists 2 primary outcomes in all. 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 NCT04733521.

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 2 Feb 2021.

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