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TERMINATEDPHASE2

Iadademstat in Combination With Paclitaxel in Relapsed/Refractory SCLC and Extrapulmonary High Grade NET

A Phase 2 Study of Iadademstat in Combination With Paclitaxel in Relapsed or Refractory Small Cell Lung Cancer and Extrapulmonary High Grade Neuroendocrine Carcinomas

NCT05420636•Fox Chase Cancer Center

View on ClinicalTrials.gov

Summary

This is a non-randomized single-arm, two cohorts, phase II study of iadademstat in combination with weekly paclitaxel in patients with relapse/refractory SCLC or extrapulmonary G3 Neuroendocrine Carcinomas. A total of 42 patients with SCLC (21 patients) and G3 NEC (21 patients) will be enrolled (including those enrolled in the safety lead-in portion).

Detailed Description

Patients with SCLC or extrapulmonary high grade neuroendocrine carcinomas with progression on or after platinum-based chemotherapy will be enrolled on this multi-center, single-arm phase II study. Patients must have histologically proven metastatic/unresectable SCLC or extrapulmonary G3 NEC (Ki-67 index \> 20% with poorly differentiated histology), or metastatic/unresectable prostate or bladder cancer with high-grade neuroendocrine or small cell component. Patients must have received at least 1, but no more than 3 prior lines of therapy, which must include a platinum based agent. Patients will be treated with iadademstat given at a dose of 150 microgram PO administered on a 5 day on-2 day off schedule every week and weekly paclitaxel at a dose of 80 mg/m2 IV). This fix dose of 150 microgram (liquid formulation) is in line with the 90 mg /m2/d BSA adjusted dose selected as RP2D in a 5d on, 2d off weekly schedule for iadademstat liquid formulation in combination with azacitidine per the ALICE AML Ph2 trial that showed to consistently achieve on average 90% target engagement. A safety lead-in phase with 12 patients will be conducted and these patients will be included in the final analysis. total of 42 patients with SCLC (21 patients) and G3 NEC (21 patients) will be enrolled (including those enrolled in the safety lead-in portion).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients must have histologically or cytologically confirmed metastatic or unresectable, extrapulmonary G3 NEC (Ki-67 index \> 20% with poorly-differentiated histology), SCLC, or prostate or bladder cancer with high-grade neuroendocrine or small cell component
•2. Patients must have been previously treated with platinum-based chemotherapy regimens (cisplatin, carboplatin or oxaliplatin). Patients may have received up to 3 lines of treatment in the metastatic setting that might include immune checkpoint inhibitors, but no previous taxane based therapy. However, patients who have received neoadjuvant/adjuvant therapy with taxanes more than six months from enrollment are allowed to participate.
•3. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension in accordance with RECIST criteria v. 1.1 as described in detail in section 11.0
•4. Patients who have received prior anti-PD1 or anti-PD-L1 therapy are eligible to enroll 5 Age \> 18 years. 6 ECOG performance status 0-1 7 Body weight \>/= 50 kg (110 lbs) 8 Patients must have normal organ and marrow function as defined below
•* Absolute neutrophil count \> 1,500/mcL
•* Hemoglobin \> 9 mg/dl
•* Platelets \> 100,000/mcL (patients cannot receive platelet transfusions to meet eligibility criteria)
•* Total bilirubin \< 1.5 X ULN (Pts with Gilbert's can enroll if conjugated bilirubin is within normal limits)
•* AST/ALT (SGOT/SGPT) \< 3 x ULN if not disease related. If liver metastasis, AST/ALT up to 5 x ULN allowed.
•* Creatinine \<1.5 X ULN OR
+10 more criteria

Exclusion Criteria

•1. Patients who have received more than 3 lines of therapy
•2. Patients who have not received any platinum-based therapy
•3. Patients who have received previous therapy with taxanes, unless received in the neoadjuvant/adjuvant setting and longer than six months from last taxane treatment.
•4. ECOG performance status \>/=2
•5. Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen as per treating MD
•6. Patients who have received radiotherapy less than 2 weeks prior to first dose of study medication.
•7. Surgical procedure or clinically significant trauma within 4 weeks of first dose of study treatment.
•8. Treatment with any investigational agent ≤ 3 weeks prior to first dose of study treatment.
•9. Patients with gastrectomy or pre-existing gastrointestinal (GI) disorders that may interfere with the proper absorption of the drug(s), as per conclusion of the clinical Investigator.
•10. Patients medicated with, or the expected need for treatment with agents reported to have LSD1 inhibitory activity (such as tranylcypromine or phenelzine) within 3 weeks of treatment start also refer to section 5.2 for the list of concomitant medications.
+15 more criteria

Locations (3)

Roswell Park Cancer Institute

Buffalo, New York, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Key Dates

Start Date

December 21, 2022

Primary Completion Date

July 23, 2025

Completion Date

July 23, 2025

Last Updated

July 30, 2025

Enrollment

ACTUAL participants

Conditions

Small-cell Lung CancerNeuroendocrine Carcinoma

Interventions

Iadademstat

DRUG

Paclitaxel

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Iadademstat in Combination With Paclitaxel in Relapsed/Refractory SCLC and Extrapulmonary High Grade NET

Inclusion Criteria

Exclusion Criteria

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