IRB #

STUDY00021423

Title

A Phase 1/2 Study of RTX-240 as a Monotherapy and in Combination with Pembrolizumab

Principal Investigator

Richard Maziarz

Study Purpose

This study is designed to test how safe and effective RTX-240 is in participants with certain types of solid-tumor cancers or a blood cancer called acute myeloid leukemia (AML). The study will evaluate whether RTX-240 causes any changes in your health (or side effects), how well it may work at treating your cancer, how much needs to be given for it to work and how often it should be given.

This study has four parts:
Part 1 is called Dose Escalation because different dose levels will be tested to determine the best dose for Part 2 of this study. Part 1 of the study is for participants with solid tumors that cannot be removed by surgery and/or has come back after previous treatment. All participants will receive RTX-240.

Part 2 is called Dose Expansion. Part 2 of the study will open only when the best dose from Part 1 has been determined and will be open only for specific kinds of cancer. Part 2 of the study is limited to 4 particular kinds of cancer. Each kind of cancer will be enrolled in a separate group as follows:
- Group 1: Non-small cell lung cancer (NSCLC)
- Group 2: Melanoma
- Group 3: Renal cell carcinoma (RCC)
- Cohort 4: Microsatellite instability high (MSIH) or Mismatch repair deficit (MMRD) tumors, Merkel cell carcinoma (MCC), and cutaneous squamous cell carcinoma (SCC)

Part 3 will include participants with a type of blood cancer called Acute Myelogenous Leukemia (AML) that has come back after treatment or did not respond to treatment.

Part 4 will test RTX-240 in combination with a drug called pembrolizumab (Keytruda) in participants with solid tumors.

Medical Condition(s)

This study is for participants whose cancer has come back after treatment (relapsed) or did not respond to standard treatment (refractory) or is a locally advanced, solid tumor that cannot be removed by surgery (unresectable) and for which no standard therapy exists, or for which the participant is ineligible or has declined standard therapy.

Part 3 will include participants with a type of blood cancer called Acute Myelogenous Leukemia (AML) that has come back after treatment or did not respond to treatment.

Eligibility Criteria

Inclusion Criteria:
1. Relapsed, refractory, or locally advanced solid tumor for which no standard therapy exists, or for which the participant is ineligible or has declined standard therapy. Participants with relapsed or refractory AML may also be enrolled.

2. Measurable disease

3. Recovery from the acute adverse effects of prior therapies. Chronic adverse effects, such as hypothyroidism or vitiligo from prior therapy are acceptable.

4. Completion of prior therapy, including radiotherapy, ≥ 28 days or 5 half-lives prior to study treatment, whichever is shorter.

5. Adequate organ function based on laboratory tests

6. Adequate blood cell counts

7. Participants are ≥ 18 years of age

8. Agreement to use highly effective or acceptable methods of pregnancy prevention throughout and for 6 months following the last dose of study treatment

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

The amount of time from when participants have signed the informed consent to their last visit will vary depending on how they respond to treatment. If the disease progresses (gets worse), or unacceptable side effects are experienced or the participant or their study investigator decides the study participant should stop, an End of Treatment (EoT) visit will occur. After the EoT visit, participants will be followed by the study investigator for up to 15 years from the first dose of RTX-240. Since this study involves a drug where new genetic material was transferred with a virus into blood cells to create the drug, the FDA requires that the Sponsor monitor participants overall progress to look for any possible long-term side effects. Any changes in participants health or delayed side effect that may be due to RTX-240 will be reported to the Sponsor.

Minors Included

No

Contact

Knight Cancer Institute Clinical Trials
503-494-1080
trials@ohsu.edu

Sponsor

Rubius Therapeutics

Recruitment End

04/28/2023

Compensation Provided

No


Go Back