CT7439_001 - A Modular, Multi-Part, Multi-Arm, Phase 1/2 Study to Evaluate the Safety and Tolerability of CT7439 Alone and in Combination with Anticancer Treatments in Participants with Solid Malignancies

Research summary

This modular, multi-part, multi-arm, Phase 1/2, FIH study allows the evaluation of the safety and tolerability of CT7439, dosed as a monotherapy and in combination with anticancer treatment in participants with solid malignancies. Module 1 will initially focus on monotherapy in participants with locally advanced or metastatic solid malignancies and include dose escalation cohorts (Part A) and dose optimization cohorts (Part B) (Appendix A). In Parts A and B of Module 1, a SRC, consisting of study investigators and sponsor medical personnel, will be formed to monitor the safety, tolerability, PK, and PDc data during this part of the study. In Part A, cohorts will be opened sequentially following review from the SRC who will make recommendations on CT7439 dosage selection for subsequent cohorts. In Part A of Module 1, a minimum of 3 participants per cohort must have completed the DLT assessment period before the next dose cohort is opened to enrollment. In response to emerging data the SRC may authorize the enrollment of an additional 3 participants in a cohort and/or the replacement of participants. Following definition of the minimally biologically active dose (MBAD), the SRC may initiate Part B of Module 1 to gather data to further explore dose optimization of CT7439. Further cohort(s) of specific participant sub-populations may be initiated in Module 1 following approval of a protocol amendment.

Principal Investigator

Dr Simon Lord

Contact us

Email: orh-tr.earlyphasenurses@nhs.net

IRAS number

1010326