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    DRUG:

    PLX038

    i
    Other names: PLX038, long-acting PEGylated SN-38, PEG-SN-38, DFP-13318, PLX-0264, Polyethylene-glycol-SN 38-conjugates, polyethyleneglycol-7-ethyl-10-hydroxycamptothecin, ultra-long acting PEG-SN38, PLX-038
    Company:
    ProLynx
    Drug class:
    Topoisomerase I inhibitor, DDR enhancer
    Related drugs:
    29d
    POP-ART: A Study on Tuvusertib (Oral ATR Inhibitor) in Combination With PLX038 (Topo1 Inhibitor) in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=92, Not yet recruiting, Institut Curie
    New P1 trial • Combination therapy • Metastases
    |
    PLX038 • tuvusertib (M1774)
    4ms
    PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications (clinicaltrials.gov)
    P1/2, N=120, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting
    Enrollment open
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
    |
    MYCN amplification
    |
    PLX038
    4ms
    PLX038 for Treatment of Metastatic Platinum-resistant Ovarian, Primary Peritoneal, and Fallopian Tube Cancer (clinicaltrials.gov)
    P2, N=43, Recruiting, Mayo Clinic | Trial primary completion date: Feb 2024 --> Feb 2025
    Trial primary completion date • Metastases
    |
    ABCG2 expression
    |
    PLX038 • firtecan pegol (PEG-SN38)
    5ms
    TOPOLOGY: A Study to Evaluate the Efficacy and Toxicities of PLX038, in Patients With Locally Advanced or Metastatic Triple-negative Breast Cancer (clinicaltrials.gov)
    P2, N=44, Not yet recruiting, Institut Curie
    New P2 trial
    |
    PLX038
    5ms
    PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications (clinicaltrials.gov)
    P1/2, N=120, Not yet recruiting, National Cancer Institute (NCI)
    New P1/2 trial
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
    |
    MYCN amplification
    |
    PLX038
    5ms
    PLX038 for Treatment of Metastatic Platinum-resistant Ovarian, Primary Peritoneal, and Fallopian Tube Cancer (clinicaltrials.gov)
    P2, N=43, Recruiting, Mayo Clinic | Suspended --> Recruiting
    Enrollment open • Metastases
    |
    ABCG2 expression
    |
    PLX038 • firtecan pegol (PEG-SN38)
    6ms
    PLX038 for Treatment of Metastatic Platinum-resistant Ovarian, Primary Peritoneal, and Fallopian Tube Cancer (clinicaltrials.gov)
    P2, N=43, Suspended, Mayo Clinic | N=31 --> 43
    Enrollment change • Metastases
    |
    ABCG2 expression
    |
    PLX038 • firtecan pegol (PEG-SN38)
    10ms
    A Phase I Study of PLX038 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=40, Completed, ProLynx LLC | Unknown status --> Completed | N=72 --> 40 | Trial completion date: Jun 2020 --> Jul 2023 | Trial primary completion date: Dec 2019 --> Feb 2023
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    PLX038
    10ms
    PLX038 for the Treatment of Patients With Platinum-resistant Ovarian, Primary Peritoneal, and Fallopian Tube Cancer (clinicaltrials.gov)
    P2, N=31, Suspended, Mayo Clinic | Active, not recruiting --> Suspended
    Trial suspension
    |
    PLX038 • firtecan pegol (PEG-SN38)
    over1year
    PLX038: a long-acting topoisomerase I inhibitor with robust anti-tumor activity in ATM deficient tumors and potent synergy with PARP inhibitors. (PubMed, Mol Cancer Ther)
    A patient with an ATM mutated breast cancer treated with PLX038 and the PARP inhibitor rucaparib achieved rapid, symptomatic, and radiographic complete response lasting twelve months. Single agent PLX038 or PLX038 in combination with DNA damage response inhibitors are novel therapeutic paradigms for patients with ATM-loss cancers.
    Journal • BRCA Biomarker • PARP Biomarker
    |
    BRCA1 (Breast cancer 1, early onset) • ATM (ATM serine/threonine kinase)
    |
    Rubraca (rucaparib) • PLX038
    over1year
    Improving trial access for people with rare CNS tumors: an NCI-CONNECT phase I/II trial of PLX038 in tumors with MYC/MYCN amplifications incorporating correlative studies and patient reported outcomes (SNO 2022)
    NCI-CONNECT's commitment to innovative designs can mitigate some of the barriers to access experimental therapy for people with rare CNS tumors. This basket trial will enroll participants with unifying molecular features and potential susceptibility to PLX038 despite different histological diagnoses. Furthermore, incorporation of comprehensive PROs will help identify clinical benefit and tolerability while correlative studies in tumor and other tissues will help identify biomarkers of response or resistance.
    Clinical • P1/2 data • Patient reported outcomes
    |
    MYC (V-myc avian myelocytomatosis viral oncogene homolog) • MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
    |
    MYCN amplification
    |
    PLX038
    almost2years
    PLX038 (PEGylated SN38) and Rucaparib in Solid Tumors and Small Cell Cancers (clinicaltrials.gov)
    P1/2, N=65, Recruiting, National Cancer Institute (NCI) | Suspended --> Recruiting | N=10 --> 65
    Enrollment open • Enrollment change
    |
    BRCA (Breast cancer early onset)
    |
    Rubraca (rucaparib) • PLX038 • firtecan pegol (PEG-SN38)
    over2years
    PLX038 (PEGylated SN38) and Rucaparib in Solid Tumors and Small Cell Cancers (clinicaltrials.gov)
    P1/2, N=10, Suspended, National Cancer Institute (NCI) | N=65 --> 10 | Recruiting --> Suspended
    Enrollment change • Trial suspension
    |
    BRCA (Breast cancer early onset)
    |
    Rubraca (rucaparib) • PLX038 • firtecan pegol (PEG-SN38)
    over3years
    PLX038 (PEGylated SN38) and Rucaparib in Solid Tumors and Small Cell Cancers (clinicaltrials.gov)
    P1/2, N=62, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2022 --> Dec 2024 | Trial primary completion date: Dec 2022 --> Dec 2023
    Trial completion date • Trial primary completion date
    |
    BRCA (Breast cancer early onset)
    |
    Rubraca (rucaparib) • PLX038 • firtecan pegol (PEG-SN38)