A Phase 1 / 2, Multicenter Trial to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of REC-1245 in Participants With Unresectable, Locally Advanced, or Metastatic Cancer

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.

This study will be conducted at several sites in the US and Canada.

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".

Find a testing site close to you.

Testing Locations

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Recruiting

Contact:

Anh Nguyen

(416) 946-4501

anh.nguyen2@uhn.ca

McGill University Health Centre (MUHC) - The Montreal

Montreal, Quebec, Canada

Recruiting

Contact:

Phuong-nam (Nathalie) Nguyen

(514) 934-1934

Phuong-nam.Nguyen@muhc.mcgill.ca

City of Hope

Duarte

Recruiting

Contact:

Mihae Song

(877) 467-3411

misong@coh.org

Cleveland Clinic

Cleveland

Recruiting

Contact:

Jessica Grenbenc

(216) 444-7923

canceranswer@ccf.org

START Mountain Region

West Valley City

Recruiting

Contact:

Marie Asay

(801) 907-4750

marie.asay@startresearch.com

Clinical Trial Information

DAHLIA Trial of REC-1245 in Biomarker-enriched Solid Tumors and Lymphoma

A Phase 1/2, Multicenter Trial to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of REC-1245 in Participants With Unresectable, Locally Advanced, or Metastatic Cancer

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

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

You might be able to enroll if your cancer has certain genetic changes. This includes solid tumors that are confirmed as MSI and/or dMMR. If you have these changes, your cancer also needs to have gotten worse, or you cannot receive or cannot tolerate a type of immune-boosting treatment called a checkpoint inhibitor. For Phase 1A only, if your cancer is locally confirmed as TMB high, you 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, increasing amounts (or dose levels) of REC-1245 will be tested to see the safety and tolerability of REC-1245. The Dose Confirmation part will assess two amounts of REC-1245 which were safe and tolerable, to find the dose level to take to Phase 2.

In the Phase 2 Dose Expansion, the safety and tolerability of the selected amount of REC-1245 will be tested further, and how well the drug works will also be tested.

Phase 1

People selected to take part in the study will be enrolled and treated with increasing amounts of REC-1245 to evaluate the safety of REC-1245, how well the body processes REC-1245 (a process called PK/PD), and to find the recommended dose for Phase 2. More people will then take part to further confirm the selected dose of REC-1245.

Phase 1A-Open

Phase 2

Phase 2 will study REC-1245 at the recommended amount which was found in Phase 1, in groups of people with specific cancer types, to look further at safety and efficacy of this dose.

Currently not open

The Risks of Taking Part in a Clinical Trial

This clinical trial is meant to study an investigational medication, meaning that neither the safety nor the effectiveness of the drug has been established. Taking part in this study may involve risks that are currently unknown. The known risks of taking part in this study will be explained to you during the informed consent process. If you are considering joining the trial, talk to your doctor about the clinical study. If you are interested in taking part, you will have the chance to ask questions and learn about these risks, so you can decide if the study is right for you.

Each clinical study, including this one, has its own guidelines for who can take part, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.

If you are interested in participating, please visit clinicaltrials.gov.