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Small Cell Lung CancerPhase 1/2NCT05731518

SC0245 and Irinotecan in Treating Patients With Relapsed Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

A Phase 1/2 study testing SC0245 and Irinotecan in people with Small Cell Lung Cancer, run by Biocity Biopharmaceutics Co., Ltd. at 1 site in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

This study is a single arm, multi-center, open label phase Ib/II study of SC0245 and Irinotecan combination therapy in subjects with extensive-stage small cell lung cancer (ES-SCLC) as a second therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Cancer
What is being tested?
SC0245 and Irinotecan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
1 siteChina
Study dates
23 Feb 2023to 28 Feb 2026
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

  • Histologically or cytologically confirmed solid tumor.
  • Phase 1b dose-escalation stage: patients with advanced solid tumors, who have received standard treatment, for who no standard treatment exists, who are not suitable for standard treatment at the current situation, or who could not tolerate standard treatment.
  • Phase 1b dose-expansion stage and phase 2: patients with ES-SCLC who have received first-line platinum-based regimen chemotherapy with or without immunotherapy or intolerance to such therapy.
  • Measurable lesions according to RECIST version 1.1 (only applicable for phase 1b dose-expansion and Phase 2).
  • Male or non-pregnant, non-lactating female patients age ≥18 years on day of signing the informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
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  • Life expectancy ≥ 3 months.
  • Adequate organ function .
  • Females of child-bearing potential (nonlactating) must have a negative blood pregnancy test within 7 days before enrollment, and must agree to use a medically effective contraception from the time they provided the informed consent until at least 6 months (or at least 180 days) after the last dose of study drug, unless surgical sterilization or menopause for more than 1 year. Patients who are sexually active men with a female partner of child-bearing potential must agree to use adequate contraception from the time they provided informed consent until at least 6 months after the last dose.
  • Subjects voluntarily participate in this study and sign the informed consent form.

Who cannot join

  • Received chemotherapy within 3 weeks before first dose of study drug (6 weeks for nitrosoureas or mitomycin C)
  • Received wide field radiotherapy within 4 weeks before first dose of study drug (previous palliative radiation therapy for metastatic disease is permitted if it has been completed at least 1 week before first dose of study drug and related toxicity has recovered to ≤ grade 1)
  • Received any monoclonal antibody, radioimmunoconjugate or antibody-drug conjugates (ADC) within 5 half-lives or 4 weeks (whichever is shorter) before first dose.
  • Received any other type of anti-tumor therapy including other investigational drugs or treatments not listed above within 4 weeks before first dose of study drug.
  • Had major organ surgery, except diagnostic biopsy, or significant trauma within 4 weeks, or not fully recovered from surgery within 4 weeks before first dose of study drug.
  • Received traditional Chinese herbal medicines with anti-tumor indications within 2 weeks before first dose of study drug.
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  • Previously received any Ataxia-Telangiectasia and Rad3 Related（ATR）inhibitor.
  • Continuous toxicities due to prior treatments that do not recover to ≤ Grade 1 severity per NCI CTCAE v5.0 except for clinically non-significant events judged by the Investigator (e.g., alopecia, grade 2 peripheral neurotoxicity, stable hypothyroidism with hormone replacement therapy, etc.)
  • Allergy to any component of the SC0245 tablets and irinotecan injection or who meet contraindications to irinotecan. In addition, the prohibited concomitant drugs in irinotecan label should be avoided.
  • Crigler-Najjar syndrome (Type I and II) or UGT1A1 mutation that increases irinotecan toxicity (Gilbert's syndrome).
  • Central nervous system (CNS) metastases meeting any of the following condition:
  • Presence of new or progressive lesions in brain by imaging within 4 weeks prior to first dose of study drug
  • Presence of symptoms of CNS metastasis
  • Received corticosteroids, radiotherapy, or dehydration drugs within 1 week to control symptoms of CNS metastasis (except for patients who completed radiotherapy for brain metastases, no use of cortisol and dehydration drugs without neurologic symptoms for more than 1 week, and brain metastases are in a stable state or have shrinkage during follow-up visit at least 2 weeks later, which need to be confirmed before first dose of study drug)
  • Carcinomatous meningitis
  • Brain stem (midbrain, pons, medulla oblongata) and spinal cord metastases
  • Active infections that require systematic treatment
  • Severe cardiovascular disorder, who meet any of the following conditions:
  • corrected QT interval(QTc)> 470 ms
  • Severe cardiac rhythm or conduction abnormalities, including but not limited to complete left bundle branch block, atrioventricular block of degree II or above, rapid ventricular tachycardia (including frequent premature ventricular contractions), torsades de pointes.
  • Any risk factors that increase the prolongation of the QTc interval, such as uncorrectable hypokalemia, genetic long QT syndrome, taking medications that prolong the QTc interval (mainly antiarrhythmic drugs of Class Ia, Ic, or III)
  • Congestive heart failure (New York Heart Association Class≥3), or a left ventricular ejection fraction of less than 50%
  • Clinically uncontrolled hypertension, defined as systolic blood pressure (SBP) ≥ 160 mmHg and diastolic blood pressure (DBP) ≥ 100 mmHg after medication.
  • Acute coronary syndrome, aortic dissection, myocardial infarction, unstable angina pectoris, cerebrovascular accident, or other Grade 3 or higher cardiovascular or cerebrovascular event within 6 months prior to the first dose
  • Major gastrointestinal surgery, or malabsorption syndrome, or are unable to swallow tablets that may impair the absorption of SC0245 tablets, or other active diseases or pathological conditions that may impact absorption, distribution, metabolism, excretion of SC0245 (such as uncontrollable nausea, vomiting, diarrhea, intestinal obstruction) as judged by the Investigator within 4 weeks before first dose of study drug.
  • Tertiary-interstitial effusion (e.g., pericardial, pleural, and peritoneal effusion) requiring repeated drainage or other treatments, but still could not be controlled within two weeks before first dose of study drug and are judged unsuitable to participate in the study by the Investigator.
  • Patients with other known malignant diseases. Exceptions: History of curative treatment for malignancy with no recurrence within 5 years; adequately treated non-melanoma skin cancer or lentigo malign; carcinoma in situ adequately treated with no signs of recurrence
  • UGT1A1 mutation.
  • Patients with underlying medical conditions (including laboratory abnormalities), alcohol or drug abuse or dependence that may affect study drug administration or the interpretation of drug toxicity or adverse events (AEs), or result in poor compliance, and are judged unsuitable to participate in the study by the Investigator.

Trial locations and contacts

1 site in 1 country.

SHUN LU, Prof contact

13601813062

Shun_lu@hotmail.com

YONGFENG YU, Chief contact

18017321559

yuyongfeng212@126.com

China1 site, 1 recruiting

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 200030

    SHUN LU, Prof, 13601813062, Shun_lu@hotmail.com

    YONGFENG YU, Chief, 18017321559, yuyongfeng212@126.com

    Recruiting

Other trials in China

About this study

Official title: A Phase Ib/II , Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Effects of SC0245 in Combination With Irinotecan in Patients With ES-SCLC

This study is a single arm, multi-center, open label phase Ib/II study of SC0245 and Irinotecan combination therapy in subjects with extensive-stage small cell lung cancer (ES-SCLC) as a second therapy. This study will have three parts, phase 1 dose escalation (Part 1), phase 1 dose expansion (Part 2), and phase 2 combination therapy (Part 3).

Read the detailed description

This study will have three parts, phase 1 dose escalation (Part 1), phase 1 dose expansion (Part 2)， and phase 2 combination therapy (Part 3).

Subjects will receive SC0245 and Irinotecan combination therapy. The study is composed of 67 subjects.

Irinotecan 80mg/m2 via IV administered for every 4 weeks (fixed dosing) in Day 1 Day8 and Day 15 of each cycle, and SC0245 administered with a 3-day on and 4-day off schedule in Day 1 Day8 and Day 15 of each cycle. One cycle is consisted of 28 days.

Study treatment will be continued until objective disease progression (unless other criteria for treatment discontinuation are met). Tumor evaluation using CT or MRI by RECIST 1.1 every 8weeks(±1week) until objective disease progression. RECIST 1.1 scans will be analyzed by the investigator on site. If a subject discontinues study treatment prior to disease progression, they should continue to be assessed using RECIST 1.1 until disease progression and then followed up for survival.

Primary Objective:

Part 1 (phase 1 dose escalation): To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of SC0245 in combination with irinotecan in patients with advanced solid tumors.

Part 2 (phase 1 dose expansion): To evaluate the safety and tolerability of SC0245 in combination with irinotecan in patients with relapsed extensive-stage small cell lung cancer (ES-SCLC).

Part 3(phase 2 combination therapy): To evaluate the preliminary anti-tumor activity of SC0245 in combination with irinotecan in patients with relapsed extensive-stage small cell lung cancer (ES-SCLC).

Secondary Objective:

Part 1 (phase 1 dose escalation): To characterize the PK profile and the preliminary anti-tumor activity.

Part 2 (phase 1 dose expansion): To characterize the PK profile, safety and tolerability and the preliminary anti-tumor activity in patients with relapsed extensive-stage small cell lung cancer (ES-SCLC).

Part 3(phase 2 combination therapy): To characterize the safety and tolerability and the preliminary anti-tumor activity in patients with relapsed extensive-stage small cell lung cancer (ES-SCLC).

Being tested
SC0245, Irinotecan
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

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

  • SC0245Drug

    Also called SC0245 tablet

    SC0245 Quaque Die(QD) administered with a 3-day on and 4-day off schedule in Day 1 Day8 and Day 15 of each cycle. One cycle is consisted of 28 days.

  • IrinotecanDrug

    Also called Irinotecan hydrochloride injection

    Irinotecan 80mg/m^2 via IV administered for every 4 weeks (fixed dosing) in Day 1 Day8 and Day 15 of each cycle. One cycle is consisted of 28 days.

Study groups in NCT05731518
Study groupRoleWhat they receive
SC0245 and irinotecan combinationExperimentalSC0245 and irinotecan combination are administered one cycle that is consisted of 28 days until disease progression or death or loss of follow-up or withdrawal.
Receives: Drug: SC0245; Drug: Irinotecan

What is being measured

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

  1. Part 1 (phase 1 dose escalation):Maximum tolerated dose (MTD), and recommended phase 2 dose (RP2D) of SC0245 and irinotecan

    MTD Will be defined as the highest dose level at which =< 30% patients experience dose limiting toxicity. Dose-limiting toxicity as described in the protocol that is not related to disease progression, intercurrent illness or concomitant medications and that, despite optional therapeutic intervention, meets protocol-defined criteria. The RP2D will be determined based on MTD and the feasibility of the administration.

    Measured: Up to 28 days

  2. Part 2 (phase 1 dose expansion):Safety and tolerability in terms of adverse events

    Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters.

    Measured: From the first dose of study treatment until 30 days after the last dose, up to approximately 24 months

  3. Part 3(phase 2 combination therapy):Objective response rate (ORR)

    Defined as the percentage of participants having a CR or PR based on investigator assessment per RECIST v1.1.

    Measured: Up to 24 months.

Secondary outcomes (8)

  1. Disease Control Rate (DCR) Based on RECIST v1.1

    Defined as the percentage of participants having CR, PR, or stable disease (SD) based on investigator assessment per RECIST v1.1.

    Measured: Assessed every 8 weeks, up to 24 months.

  2. Duration of Response (DoR) Based on RECIST v1.1

    Defined as the time from the earliest date of disease response (CR or PR) until earliest date of disease progression or death due to any cause.

    Measured: Assessed every 8 weeks, up to 24 months.

  3. Progression-free Survival (PFS) Based on RECIST v1.1

    Defined as the time from the start of combination therapy until the earliest date of disease progression or death due to any cause.

    Measured: Assessed every 8 weeks, up to 24 months.

  4. Overall Survival (OS)

    Defined as the time from the start of combination therapy until death due to any cause.

    Measured: At 1 year and 2 years.

  5. Incidence of adverse events of SC0245 and irinotecan

    Will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. A toxicity will be considered to be an adverse event that is possibly, probably or definitely related to treatment. The maximum grade of toxicity for each category of interest will be recorded for each patient, and the summary results will be tabulated by category, grade, and dose level. Serious (>= grade 3) toxicities will be described on a patient-by-patient basis and will include any relevant baseline data.

    Measured: From the first dose of study treatment until 30 days after the last dose, up to approximately 24 months

  6. Maximum observed blood concentration (Cmax) of SC0245

    Defined as assessments for measuring maximum blood concentration of SC0245

    Measured: Pre-dose up to approximately 6 months

  7. AUC Area under the Plasma Concentration versus Time Curve (AUC) of SC0245

    Defined as assessments for evaluating the Area Under the Concentration-Time Curve (AUC)

    Measured: Pre-dose up to approximately 6 months

  8. Elimination half-life (t1/2) of SC0245

    Defined as the time required for half of the drug SC0245 to be eliminated from the blood.

    Measured: Pre-dose up to approximately 6 months

Timeline

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

  1. First posted16 Feb 2023
  2. Study start23 Feb 2023
  3. Primary completion30 Sep 2025 (estimated)
  4. Study completion28 Feb 2026 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
67 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05731518
Sponsor's protocol ID
SC0245-102
Status last verified
Feb 2023
First submitted
9 Jan 2023
Last updated
14 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SC0245 and Irinotecan in people with Small Cell Lung Cancer, run by Biocity Biopharmaceutics Co., Ltd. at 1 site in China.

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 10 inclusion and 29 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 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 SHUN LU, Prof (13601813062, Shun_lu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1 (phase 1 dose escalation):Maximum tolerated dose (MTD), and recommended phase 2 dose (RP2D) of SC0245 and irinotecan (time frame: Up to 28 days). The study lists 3 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 NCT05731518.

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 14 Jul 2023.

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