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New treatment option for Locally Advanced / Metastatic Solid Tumors
Official title CR-001 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT07335497
What this study is testing
What is CR-001?
CR-001 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for locally advanced / metastatic solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to determine the safety and tolerability of monotherapy CR-001 and identify the maximum tolerated dose (MTD), and/or optimal biologic dose and Recommended Phase 2 Dose(s) (RP2D) in participants with locally advanced or metastatic solid tumors.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Key Life expectancy ≥ 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1
- Adequate organ function and hematologic reserve based on laboratory parameters
- Have measurable disease defined by RECIST v1.1
- For Backfill and Dose Optimization: Willingness to provide recent archival tumor tissue sample or willingness to undergo biopsy
You likely can't join if
- Has malignancies other than disease under study within the past 3 years
- Has conditions requiring treatment with clinically significant or increasing doses of systemic steroid therapy
- Has not adequately recovered from recent major surgery
- Has ongoing clinically significant toxicity related to prior therapy
- Has active central nervous system (CNS) metastases
- Has active autoimmune disease requiring systemic therapy in the past 2 years (replacement therapy is permitted)
See the full eligibility criteria
- Key Life expectancy ≥ 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1
- Adequate organ function and hematologic reserve based on laboratory parameters
- Have measurable disease defined by RECIST v1.1
- For Backfill and Dose Optimization: Willingness to provide recent archival tumor tissue sample or willingness to undergo biopsy
- Tumor Indication specific
- For dose escalation or backfill: progressing from, intolerant to, or ineligible for (due to unavailability or contraindication) local standard of care therapies and have one of the following locally advanced or...
- Hepatocellular carcinoma
- Biliary tract cancer
- Endometrial carcinoma
- Cervical cancer
- Ovarian cancer
- Gastric or gastroesophageal cancer
- Colorectal cancer
- Non-small cell lung cancer Key
- Has malignancies other than disease under study within the past 3 years
- Has conditions requiring treatment with clinically significant or increasing doses of systemic steroid therapy
- Has not adequately recovered from recent major surgery
- Has ongoing clinically significant toxicity related to prior therapy
- Has active central nervous system (CNS) metastases
- Has active autoimmune disease requiring systemic therapy in the past 2 years (replacement therapy is permitted)
- Has a history of serious Grade ≥ 3 immune-related adverse event (irAE)
- Has a history of noninfectious pneumonitis/interstitial lung disease
- Has an active severe infection
- Has received a live or attenuated vaccine within 30 days of the first dose
- Has undergone prior allogeneic stem cell or solid organ transplantation
- Has protocol-specified events related to gastrointestinal perforation, surgery, wound healing complications, and bleeding
- Has clinically significant cardiovascular disease NOTE: Other protocol defined Inclusion and Exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Los Angeles, California, United States
- Denver, Colorado, United States
- Orlando, Florida, United States
- Sarasota, Florida, United States
- Detroit, Michigan, United States
- Grand Rapids, Michigan, United States
- New York, New York, United States
- Columbus, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- San Antonio, Texas, United States
- West Valley City, Utah, United States
- South Brisbane, Queensland, Australia
- Dublin, Ireland, Ireland
- Cluj-Napoca, Cluj, Romania
- Bucharest, Romania
- Seoul, Seoul, South Korea
- Seongnam-si, South Korea
+ 3 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Los Angeles, California, United States; Denver, Colorado, United States; Orlando, Florida, United States; Sarasota, Florida, United States; Detroit, Michigan, United States and 17 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.