Status and phase
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Treatments
About
This is a first in human study in patients with advanced or metastatic solid tumors. The first part of the study is an open-label, dose escalation and the second part is an open label dose expansion in specific tumor types. The study drug, CTS2190, is a PRMT1 inhibitor administered orally. The study is planned to treat up to 224 participants.
Full description
This is a Phase 1/2 multi-center, open label study in solid tumor patients. Phase 1(Part1) is a dose escalation study of oral CTS2190 in patients with solid tumors,which is planned to treat up to 144 participants.
Phase 2(Part2) is an open label, dose expansion study in specific tumor types. In both parts of the study, participants who tolerate the drug may continue the treatment until disease progression.
The study duration for each subject is defined as beginning from 28 days prior to the first dose, until the subject withdrawal of informed consent, end of treatment, loss to follow-up or death, completes 48 weeks of continuous treatment or the study ends early, whichever occurs first. The end of study is defined as the date when the last subject completes the last visit specified in the protocol.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Subjects who meet all of the following criteria can be included in this study:
Male or female ≥ 18 years of age at signing of ICF.
Part 1: histologically or cytologically confirmed locally advanced or metastatic solid tumors at screening who cannot be treated surgically and have failed standard treatment (PD during treatment or after the last treatment) recommended by the current clinical diagnosis and treatment standards or guidelines, or cannot tolerate standard treatment, or refuse standard treatment and/or currently have no effective treatment available.
Part 2: histologically or cytologically confirmed advanced solid tumors (including pancreatic cancer, non-small cell lung cancer and/or other tumors, such as gastric cancer, colorectal cancer, etc.) at screening who cannot be treated surgically and have failed standard treatment (PD during treatment or after the last treatment) recommended by the current clinical diagnosis and treatment standards or guidelines, or cannot tolerate standard treatment, or refuse standard treatment and/or currently have no effective standard treatment available.
At least one measurable tumor lesion at screening [according to RECIST V1.1 criteria (see appendix 1)].
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 (Appendix 2) at screening.
With a life expectancy ≥ 12 weeks at screening.
With good organ function at screening, including:
Female patients of non-childbearing age or female patients of childbearing age who have negative pregnancy test results and promise to take sufficient and effective contraceptive measures or adhere to abstinence from the screening period to 90 days after the last administration, or male patients who promise to take sufficient and effective contraceptive measures or adhere to abstinence from the screening period to 90 days after the last administration (see the appendix 4). Patients are not allowed to donate sperm within 6 months from the start of administration to 6 months after the end of investigational drug administration.
Patients who understand and voluntarily signs the ICF, are willing to and able to complete the scheduled visits, treatment plan, laboratory tests and other study procedures.
Exclusion criteria
Subjects should not participate in this clinical study if any of the following conditions is met:
Primary purpose
Allocation
Interventional model
Masking
224 participants in 1 patient group
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Central trial contact
Song Z B, Docotor; Xing S N, Master
Data sourced from clinicaltrials.gov
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