Over the past 30 years there has been a considerable effort on the part of researchers to improve the design and accuracy of early-phase oncology trials. One such effort is the Experimental Therapeutics Clinical Trials Network (ETCTN), a partnership program sponsored by the National Cancer Institute (NCI)–Cancer Therapy Evaluation Program (CTEP) to evaluate early-phase trials in high-priority areas of unmet need through collaboration with a dozen Lead Academic Organizations (LAOs).

NYU Langone Health’s Perlmutter Cancer Center has officially joined the ETCTN as part of the Dana-Farber/Harvard Cancer Center LAO. Janice Mehnert, MD, a professor of medicine and associate director for clinical research, is serving as site principal investigator (PI) for the network.

“This achievement exemplifies the advancement of our clinical trial capabilities, as there are only 12 LAOs nationwide.”

Janice Mehnert, MD

“Joining the ETCTN grants our center access to a broader network of early-stage trials conducted by NCI-CTEP,” Dr. Mehnert says. “This achievement exemplifies the advancement of our clinical trial capabilities, as there are only 12 LAOs nationwide.”

Testing Novel Agents in Early-Phase Trials

Kristen Spencer, DO, MPH, an assistant professor of medicine and director of the Phase 1 Developmental Therapeutics Program, is conducting early-stage research and supporting the national execution of new oncology trials, a primary focus of the ETCTN.

One NCI Investigational New Drug (NCI-IND) currently under evaluation is peposertib, a selective DNA-PK inhibitor, which showed synergy with radiotherapy and some chemotherapies in preclinical studies. Recent evidence suggests that peposertib could enhance the efficacy of standard therapeutic regimens in selected tumor types.

Dr. Spencer is serving as national PI for CTEP protocol 10276, an NCI-sponsored trial of peposertib in combination with avelumab and hypofractionated radiation therapy in patients with solid tumors and hepatobiliary malignancies.

Another NCI-IND is ASTX727, a unique fixed-dose combination of the hypomethylating agent decitabine and the cytidine deaminase inhibitor cedazuridine. When administered in combination with immunotherapy, ASTX727 may help stimulate the body’s immune system to attack cancer, and interfere with the ability of tumor cells to grow and spread.

Catherine S. Diefenbach, MD, an associate professor of medicine and director of the Clinical Lymphoma Program, is acting as PI for CTEP protocol 10508, an NCI-sponsored trial evaluating the combination of ASTX727 and nivolumab for relapsed or refractory B cell lymphoma.

“These are two examples of innovative early-phase trials initiated through the ETCTN partnership,” Dr. Spencer says, adding that faculty will have increased opportunities to design investigator-initiated studies with CTEP.

Advancing Biomarker Discovery

In addition to supporting early-stage clinical trials, the ETCTN also provides support for studies that incorporate biomarker development and molecular characterization of biospecimens.

Dr. Spencer anticipates the ETCTN partnership will streamline processes required for coordinated biomarker analyses. On a national level, Dr. Spencer is also chair of the Genomics Subcommittee of the ECOG-ACRIN Cancer Research Group, a membership-based network of nearly 1,300 academic and community-based cancer centers that design and conduct cancer research.

Collaboration with Other Research Leaders

A key benefit of the ETCTN is the opportunity to partner with other leading cancer centers, including investigators from the Dana-Farber/Harvard Cancer Center and Mayo Clinic Comprehensive Cancer Center, for their own expertise in timely activation and conduction of early-phase oncology trials, says Dr. Mehnert.

“A big unmet need in early-phase cancer trials is the sharing of best practices and collaboration in the design of new studies. We anticipate ETCTN-based collaborations will open new avenues to further the development of innovative cancer therapies.”

Janice Mehnert, MD

“A big unmet need in early-phase cancer trials is the sharing of best practices and collaboration in the design of new studies. We anticipate ETCTN-based collaborations will open new avenues to further the development of innovative cancer therapies,” Dr. Mehnert says.