If you have cancer (certain solid tumors or lymphoma, including those with specific genetic characteristics or "biomarkers"), you may be eligible to participate in a study to investigate the safety and efficacy of an investigational drug called REC-1245.

To be eligible, individuals (18 years of age or older) will have certain types of solid tumors and your cancer must have progressed, come back after treatment, or you are unable to take or tolerate at least one standard treatment for your cancer type. Individuals who have Non-Hodgkin’s lymphoma that has returned after previous treatment, or for whom standard treatments are not suitable or no longer working, may also be eligible. 

Some individuals with other types of cancer might also be able to enroll if their cancer has certain genetic changes. This includes solid tumors that are confirmed as MSI and/or dMMR. For these cancers, it's also necessary that the cancer has gotten worse, or if you cannot receive or are unable to tolerate a type of immune-boosting treatment called a checkpoint inhibitor. For Phase 1A only, individuals with cancer that is locally confirmed as TMB high could also be considered.

There are two phases to the study: Phase 1 and Phase 2. Phase 1 includes two parts: Dose Finding and Dose Confirmation. In the Dose Finding part, the safety and tolerability of REC-1245 will be explored across increasing dose levels of REC-1245. The Dose Confirmation part will assess two safe and tolerable doses to identify the dose level to take to Phase 2. In the Phase 2 Dose Expansion, we will continue to explore the safety and tolerability of the selected dose of REC-1245, as well as look at the effectiveness of this dose.

Phase 1 (Phase 1A is open now)

Participants will be enrolled and treated with increasing doses of REC-1245 to evaluate safety and PK/PD of REC-1245, and to find the recommended dose of REC-1245 for Phase 2.  Additional participants will then be enrolled to further confirm the dose.

Phase 2 (currently not open)

Phase 2 will study REC-1245, at the recommended dose identified from Phase 1, in specific disease cohorts to further assess safety and efficacy of this dose.

If you are interested in participating, please visit clinicaltrials.gov and search for "REC-1245".