Phase 1/2 clinical trial is to evaluate the safety, pharmacokinetics and pharmacodynamics of escalating doses of IDP-121 combined with chemotherapy in patients with advanced unresectable/metastatic SCLC that have progressed after 1st line platinum- based chemotherapy, considering the role of MYC amplification in the development of platinum resistance.
Age ≥18 years
Performance status (ECOG) ≤ 2
Life expectancy ≥2 months
Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements.
Persistent 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.
4. 5. 6. 7. 8. 9. • Completed treatment at least 14 days prior to the first dose of study intervention.
Are 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. Pregnant 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).
Uncontrolled 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).
Parallel
IDP-121
DrugIDP-121
MTD and RP2D
To determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of IDP-121 combined with chemotherapy (topotecan day 1 to 5 every 3 weeks; carboplatin day 1 plus etoposide days 1, 2 and 3 every 3 weeks) in patients with SCLC.
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