IDP-121 for Small cell lung cancer (relapsed/metastatic)

Inclusion criteria

• {"criterion_text":"- Inclusion Criteria Patients meeting all the following inclusion criteria will be eligible for participation in the study: 1.\tAge ≥18 years"}
• {"criterion_text":"- 2.\tPerformance status (ECOG) ≤ 2"}
• {"criterion_text":"- 3.\tLife expectancy ≥2 months"}
• {"criterion_text":"- 4.\tPatient is, in the investigator’s opinion, willing and able to comply with the protocol requirements."}
• {"criterion_text":"- 5.\tPatient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care."}
• {"criterion_text":"- 6.\tPatients diagnosed with advanced/extensive stage SCLC that have platinum-sensitive relapse after 1st line treatment defined as a Progression Free Interval (PFI) of ≥ 3 months (platinum-based chemotherapy plus IDP-121 arm) and patients with a PFI < 3 months (topotecan plus IDP-121 arm)."}
• {"criterion_text":"- 7.\tAdequate haematological or biochemical parameters as specified below a.\tHaemoglobin > 8.0 g/dl (without transfusion support within 7 days) b.\tPlatelets count > 100 x109/L (without transfusion support within 7 days). c.\tAbsolute neutrophil count (ANC) > 1.5 x109/L (without G-CSF support within 7 days) d.\tAspartate transaminase (AST): <2.5 x the upper limit range. e.\tAlanine transaminase (ALT): < 2.5 x the upper limit range. f.\tTotal bilirubin: < 2 x the upper limit range. g.\tCalculated or measured creatinine clearance: ≥ 60 mL/min (calculated from the Cockcroft-Gault formula)."}
• {"criterion_text":"- 8.\tLeft ventricular ejection fraction > 50% or above the Institutional Lower Limit of Normal (LLN), whichever is lower, determined by echocardiogram."}

Exclusion criteria

• {"criterion_text":"- Exclusion Criteria Patients eligible for this study must not meet any of the following criteria: 1.\tPersistent clinically significant or grade 3 or 4 non-haematological toxicity related to previous treatments. The presence of alopecia and NCI-CTC grade <2 symptomatic peripheral neuropathy is allowed."}
• {"criterion_text":"- 2.\tActive CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases (e.g., whole brain radiation treatment [WBRT], stereotactic radiosurgery, or equivalent) may participate only if they satisfy the following: •\tCompleted treatment at least 14 days prior to the first dose of study intervention. •\tAre clinically stable, without requirement of steroid treatment > 10 mg or prednisone or equivalent for at least 7 days prior to first dose of study intervention."}
• {"criterion_text":"- 3.\tPregnant or lactating women; men and women of reproductive potential* (as defined in the Appendix 2) who are not using effective contraceptive methods (combined hormonal contraception associated with inhibition of ovulation; progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, sexual abstinence). *A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy."}
• {"criterion_text":"- 4.\tHistory of any other neoplastic disease in the last five years (except basal cell carcinoma, skin epithelioma or carcinoma in situ of any site)"}
• {"criterion_text":"- 5.\tHistory of clinically significant hypotension."}
• {"criterion_text":"- 6.\tHistory of clinically significant allergic or hyper-sensitivity reactions."}
• {"criterion_text":"- 7.\tHistory or known clinically significant vascular disease or known high risk of vascular disease (as assessed by the treating physician) including (but not limited to): -\tThromboembolism -\tPeripheral arterial disease -\tVasculitis"}
• {"criterion_text":"- 8.\tOther relevant diseases or adverse clinical conditions: -\tCongestive heart failure or angina pectoris, myocardial infarction within 12 months before inclusion in the study. -\tUncontrolled arterial hypertension or cardiac arrhythmias (i.e., requiring a change in medication within the last 3 months or hospital admission within the past 6 months). -\tHistory of significant neurological or psychiatric disorders"}
• {"criterion_text":"- 9.\tClinically significant or active infection."}
• {"criterion_text":"- 10.\tSignificant non-neoplastic liver disease (e.g., cirrhosis, active chronic hepatitis)"}
• {"criterion_text":"- 11.\tThe patient is known to be human immunodeficiency virus (HIV) positive, unless the patient is on antiviral therapy with HIV RNA levels <50 copies/mL; Hepatitis B surface antigen-positive or active hepatitis C infection, unless treated with undetectable hepatitis B DNA or hepatitis C RNA levels; or active CMV infection (IgM positive)."}
• {"criterion_text":"- 12.\tConcomitant anti-tumour therapy within 14 days prior to Day 1 of Cycle 1."}
• {"criterion_text":"- 13.\tPrior allogeneic transplantation in the last 3 months or currently active GVHD with immunosuppressive treatment"}
• {"criterion_text":"- 14.\tLimitation of the patient’s ability to comply with the treatment or follow-up protocol."}
• {"criterion_text":"- 15.\tIf a COVID-19 vaccine is administered, it should be done >72 hours prior to study treatment initiation or after the completion of the dose-limiting toxicity (DLT) period (if patient is participating in the dose-escalation phase”)."}

Primary endpoints

• {"endpoint_text":"- Maximum tolerated dose (MTD): based on the incidence of DLTs observed at the end of Cycle 1 (21 days).","definition_or_measurement_approach":"Based on the incidence of DLTs observed at the end of Cycle 1 (21 days)."}
• {"endpoint_text":"- Recommended phase 2 dose (RP2D): dose selected for the use in the expansion phase. The RP2D will be determined in discussion with the Investigators and the Sponsor based on safety (dose limiting toxicity), PK, PD, and efficacy observed across multiple dose-escalation cohorts.","definition_or_measurement_approach":"Dose selected based on safety (DLT), pharmacokinetics (PK), pharmacodynamics (PD), and efficacy observed across multiple dose-escalation cohorts; determined in discussion with investigators and sponsor."}
• {"endpoint_text":"- The primary endpoint for the Expansion-Phase is the Overall Response Rate (ORR) and the disease control rate (DCR) based on the appropriate tumour specific guidelines/response criteria RECIST 1.1","definition_or_measurement_approach":"ORR and DCR assessed using tumour-specific guidelines/response criteria RECIST 1.1."}

Secondary endpoints

• {"endpoint_text":"- The secondary efficacy endpoints for the Expansion Phase: •\tDuration of response (DoR), defined as the time from documentation of disease response to disease progression.","definition_or_measurement_approach":"Duration of response (DoR): time from documentation of disease response to disease progression."}
• {"endpoint_text":"- •\tTime to progression (TTP), time from the first treatment day to objective disease progression; does not include deaths.","definition_or_measurement_approach":"Time to progression (TTP): time from first treatment day to objective disease progression; does not include deaths."}
• {"endpoint_text":"- •\tOverall survival (OS) defined as the interval between the first treatment day to death from any cause.","definition_or_measurement_approach":"Overall survival (OS): time from first treatment day to death from any cause."}
• {"endpoint_text":"- The secondary safety endpoints for the Expansion Phase are as follows: •\tVital signs •\tPhysical examination •\tHematology •\tBiochemistry •\tUrinalysis •\tElectrocardiograms (ECG) •\tAll grades AEs and SAEs","definition_or_measurement_approach":"Safety assessments including vital signs, physical exam, hematology, biochemistry, urinalysis, ECGs, and recording of AEs/SAEs of all grades."}

Other endpoints

• {"endpoint_text":"- Exploratory Objectives (Phase 1 and Phase 2): •\tTo determine the cMyc levels before and during treatment. •\tTo explore pharmacodynamics (PD) parameters of the activity of IDP-121. •\tTo explore/evaluate predictive biomarkers of anti-tumor efficacy of IDP-121 and/or for patient selection for future clinical evaluation.","definition_or_measurement_approach":"cMyc levels measured before and during treatment; PD parameters and predictive biomarkers explored/evaluated (specific assays/methods not specified in provided data)."}

Spain

Earliest CTIS Part Ii Submission Date

18-11-2025

Latest Decision Or Authorization Date

04-05-2026

Processing Time Days

167

Number Of Sites

10

Number Of Participants

60

Primary sponsor

Full Name

Idp Discovery Pharma S.L.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Spain