First-in-human study of ATX-898 as monotherapy and in combination with other anti-neoplastic agents, in participants with advanced solid tumors

Condition studied

Advanced solid tumors

Investigational medicinal product(s)

Every trial of Abemaciclib, Ribociclib and Fulvestrant across our registers →

Eligibility

Primary endpoint

Part 1A: Dose-limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs)/serious adverse events (SAEs) and grade ≥3 laboratory abnormalities; type, frequency, and severity of treatment-related adverse events (TRAEs) and TEAEs according to Common Terminology Criteria for Adverse Events (CTCAE) v6.0 criteria, Part 1A: Treatment-emergent changes in clinical laboratory measurements, electrocardiogram (ECG) findings, vital signs, Eastern Cooperative Oncology Group (ECOG) performance status, and physical examination findings., Part 1A: MTD or maximum tested dose and RDE., Part 1B: ORR defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST v1.1)., Part 2A: DLTs, TEAEs/SAEs and grade ≥3 laboratory abnormalities; type, frequency, and severity of TRAEs and TEAEs according to CTCAE v6.0 criteria., Part 2A: Combination RDE., Part 2B: ORR defined as the percentage of participants with confirmed CR or PR based on RECIST v1.1.

Endpoint detail

Part 1A: PK parameters: Cmax, Tmax, AUC0-τ, AUC0-t, AUC0-∞, T½, λz, CL/F, Vz/F, Rac for Cmax and AUC, and Ctrough., Part 1A: ORR defined as the percentage of participants with confirmed CR or PR based on RECIST v1.1; DCR defined as the percentage of participants with best response of confirmed CR, PR or SD; CBR defined as the percentage of participants with best response of confirmed CR, PR or SD lasting ≥ 24 weeks; TTR per RECIST v1.1; DOR per RECIST v1.1; PFS per RECIST v1.1; OS., Part 1B: TEAEs/SAEs and Grade ≥3 laboratory abnormalities; type, frequency, and severity of TEAEs according to CTCAE v6.0 criteria., Part 1B: Treatment-emergent changes in clinical laboratory measurements, ECG findings, vital signs, ECOG performance status, and physical examination findings., Part 1B: DCR defined as the percentage of participants with best response of confirmed CR, PR or SD; CBR defined as the percentage of participants with best response of confirmed CR, PR or SD lasting ≥ 24 weeks; TTR per RECIST v1.1; DOR per RECIST v1.1; PFS per RECIST v1.1;OS, Part 1B: PK parameters: Cmax, Tmax, AUC0-τ, AUC0-t, AUC0-∞, T½, λz, CL/F, Vz/F, Rac for Cmax and AUC, and Ctrough, Part 2A: TEAEs/SAEs and Grade ≥3 laboratory abnormalities; type, frequency, and severity of TEAEs according to CTCAE v6.0 criteria., Part 2A: Treatment-emergent changes in clinical laboratory measurements, ECG findings, vital signs, ECOG performance status, and physical examination findings., Part 2A: PK parameters: Cmax, Tmax, AUC0-τ, AUC0-t, AUC0-∞, T½, λz, CL/F, Vz/F, Rac for Cmax and AUC, and Ctrough, Part 2A: ORR defined as the percentage of participants with confirmed PR or CR based on RECIST v1.1; DCR defined as the percentage of participants with best response of confirmed CR, PR or SD; CBR defined as the percentage of participants with best response of confirmed CR, PR or SD lasting ≥ 24 weeks; TTR per RECIST v1.1; DOR per RECIST v1.1; PFS per RECIST v1.1; OS., Part 2B: TEAEs/SAEs and Grade ≥3 laboratory abnormalities; type, frequency, and severity of TEAEs according to CTCAE v6.0 criteria, Part 2B: Treatment-emergent changes in clinical laboratory measurements, ECG findings, vital signs, ECOG performance status, and physical examination findings., Part 2B: DCR defined as the percentage of participants with best response of confirmed CR, PR or SD; CBR defined as the percentage of participants with best response of confirmed CR, PR or SD lasting ≥ 24 weeks; TTR per RECIST v1.1; DOR per RECIST v1.1; PFS per RECIST v1.1; OS., Part 2B: PK parameters: Cmax, Tmax, AUC0-τ, AUC0-t, AUC0-∞, T½, λz, CL/F, Vz/F, Rac for Cmax and AUC, and Ctrough