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

NCT05731518 | Recruiting Phase 1

• 1 other identifier: SC0245-102
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (3)

• 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.

  Up to 28 days

• 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.

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

• 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.

  Up to 24 months.

Secondary Outcomes (8)

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

  Assessed every 8 weeks, up to 24 months.

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

  Assessed every 8 weeks, up to 24 months.

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

  Assessed every 8 weeks, up to 24 months.

• Overall Survival (OS)

  At 1 year and 2 years.

• Incidence of adverse events of SC0245 and irinotecan

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

Study Arms (1)

SC0245 and irinotecan combination

EXPERIMENTAL

SC0245 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.

Drug: SC0245; Drug: Irinotecan

Interventions

SC0245 DRUG

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.

Also known as: SC0245 tablet

SC0245 and irinotecan combination

Irinotecan DRUG

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.

Also known as: Irinotecan hydrochloride injection

SC0245 and irinotecan combination

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Biocity Biopharmaceutics Co., Ltd.: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Irinotecan

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• SHUN LU, Prof

  Shanghai Chest Hospital

  STUDY CHAIR

Central Study Contacts

SHUN LU, Prof

CONTACT

13601813062; Shun_lu@hotmail.com

YONGFENG YU, Chief

CONTACT

18017321559; yuyongfeng212@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: February 16, 2023
• Study Start: February 23, 2023
• Primary Completion: September 30, 2025
• Study Completion: February 28, 2026
• Last Updated: July 14, 2023

Record last verified: 2023-02

Locations

CN (1)