The primary purpose of this study is to evaluate the safety, tolerability and recommended dose (RD) of PM54 in combination with cytotoxic and targeted anticancer agents in adult participants with advanced solid tumors. The study will also assess the antitumor activity of PM54 in combination with cytotoxic and targeted anticancer agents in terms of objective response rate (ORR) based on investigator's assessment in participants in other cohorts.
Voluntarily signed and dated written informed consent, obtained before the start of any study-specific procedures.
Adults greater than or equal to (>=) 18 years and able to provide free and informed consent for study participation.
Tumor type, previously treated with 1 to 2 prior lines of therapy for advanced disease, which must have included at least 1 line of platinumbased chemotherapy and programmed cell death protein 1 inhibitor if locally available and approved. All histological subtypes are eligible.
Tumor type, previously treated with 1 to 3 prior lines of therapy for advanced disease.
Prior treatment with PM54 or any other ecteinascidin agent.
History of hypersensitivity to PM54 or any of the inactive ingredients.
History of other malignancies within 3 years prior to start of study intervention, except adequately resected non-melanoma skin cancer, low-risk and adequately treated prostate cancer, stage I hormone receptor (HR)-positive breast cancer or other in-situ disease at neglectable risk of relapse.
Presence of carcinomatous meningitis.
Sequential
PM54
DrugIntravenous infusion.
Irinotecan
DrugIntravenous infusion.
Doxorubicin
DrugIntravenous infusion.
Parts 1 and 2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Treatment Discontinuation or Dose Modifications
Part 1: Number of Participants with Dose-Limiting Toxicities (DLTs)
Part 2: Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
Percentage of participants who achieve a best overall response of complete response (CR) or partial response (PR), as determined by investigator assessment of tumor images according to RECIST v1.1. CR is defined as disappearance of all target lesions and all non-target lesions, with any pathological lymph nodes reduced to \<10 mm in short axis, and no new lesions. PR is defined as at least a 30% decrease in the sum of diameters of target lesions from baseline, with no progression of non-target lesions and no new lesions.
Part 1 and 2: Clinical Benefit Rate (CBR)
Percentage of participants who achieve either an objective tumor response (CR or PR or stable disease) with an absence of tumor progression during the first 12 weeks, as determined by investigator assessment according to RECIST v1.1. CR is defined as disappearance of all target lesions, with any pathological lymph nodes reduced to \<10 mm in short axis. PR is defined as at least a 30% decrease in the sum of diameters of target lesions from baseline. Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum of diameters while on study. PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters while on study, with an absolute increase of at least 5 mm, or the appearance of one or more new lesions or unequivocal progression of existing non-target lesions.
Part 1 and 2: Confirmed ORR
Percentage of participants who achieve a confirmed objective response (CR or PR), as determined by investigator assessment according to RECIST v1.1. CR is defined as disappearance of all target lesions, with any pathological lymph nodes reduced to \<10 mm in short axis. PR is defined as at least a 30% decrease in the sum of diameters of target lesions from baseline. A response is considered confirmed when a subsequent assessment performed at least 4 weeks after the initial response confirms CR or PR.
Parts 1 and 2: Disease Control Rate (DCR)
Percentage of participants who achieve a best overall response of stable disease, PR, or CR, as determined by investigator assessment according to RECIST v1.1. CR is defined as disappearance of all target lesions, with any pathological lymph nodes reduced to \<10 mm in short axis. PR is defined as at least a 30% decrease in the sum of diameters of target lesions from baseline. Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study.
Parts 1 and 2: Progression-Free Survival
This trial is not recruiting at the moment. You can still explore other options:
