Pancreatic Cancer, Pancreatic Acinar Carcinoma
Conditions
Keywords
daraxonrasib, PARP, pancreas, pancreatic cancer
Brief summary
This study is a Phase 1 clinical trial testing an oral investigational drug called SNV1521 together with a RAS-targeted cancer medicine in people with pancreatic cancer that cannot be removed by surgery or has spread. The main goals are to find doses of the drug combination that are safe and tolerable and to look for early signs that the treatment may help control the cancer. Participants will receive the study medicines in repeating cycles and will have regular blood tests, scans, and other exams to monitor side effects and how their cancer responds.
Interventions
DRUGSNV1521
SNV1521 is an oral investigational anticancer drug. In this study, SNV1521 is administered at different dose levels together with the RAS inhibitor daraxonrasib in adults with locally advanced unresectable or metastatic pancreatic cancer.
DRUGdaraxonrasib
Daraxonrasib is an oral targeted cancer medicine used in this study together with SNV1521. It is given once daily to help evaluate the safety and tolerability of the drug combination in people with advanced pancreatic cancer.
Sponsors
Synnovation Therapeutics, Inc.
Revolution Medicines, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults (18 years and older). * Diagnosis of pancreatic cancer that cannot be removed by surgery or has spread to other parts of the body. * Cancer confirmed by tissue or cell examination (histology or cytology). * At least one measurable tumor on scans. * Good enough general health and organ function to receive study treatment, as judged by the study doctor. * Able to swallow oral medicines. * Willing to follow study visit schedule and contraception requirements.
Exclusion criteria
* Serious heart, lung, liver, or other medical problems that would make study treatment unsafe. * Active, uncontrolled infections. * Other active cancers that could interfere with study assessments (except certain early-stage cancers that have been treated). * Prior treatments or medicines that are not allowed by the protocol (for example, some strong drug interactions). * Known brain or nervous system involvement from the cancer that is not stable or controlled. * Pregnant or breastfeeding, or unwilling to use required birth control during and after the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of SNV1521 plus daraxonrasib: treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities | through study completion, an average of 1 year | Number, type, and severity of treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities in participants receiving SNV1521 plus daraxonrasib, used to identify doses suitable for further study, classified and graded according to CTCAE v6.0 and protocol-defined DLT criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum plasma concentration (Cmax) of SNV1521 | through study completion, an average of 1 year | Cmax of SNV1521 following oral dosing in combination with daraxonrasib, based on concentration-time data collected at protocol-specified PK time points |
| Area under the plasma concentration-time curve (AUC) of SNV1521 | through study completion, an average of 1 year | AUC for SNV1521 following oral administration in combination with daraxonrasib, derived from concentration-time data at protocol-specified PK sampling time points |
| Maximum plasma concentration (Cmax) of daraxonrasib | through study completion, an average of 1 year | Cmax for daraxonrasib following oral administration in combination with SNV1521, derived from concentration-time data at protocol-specified PK sampling time points |
| Area under the plasma concentration-time curve (AUC) of daraxonrasib | through study completion, an average of 1 year | AUC for daraxonrasib following oral administration in combination with SNV1521, derived from concentration-time data at protocol-specified PK sampling time points. |
Contacts
CONTACTKevin O'Hayer
Outcome results
None listed