New hope for advanced cancer: experimental drug CR-001 enters human trials
NCT ID NCT07335497
First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 13 times
Summary
This study tests a new drug called CR-001 in adults with advanced solid tumors that have spread. The goal is to find the safest dose and see if it can shrink tumors. About 290 people will take part in this early-phase trial.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 290 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Feb 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria * 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 inclusion criteria: * 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 metastatic tumor types: * Hepatocellular carcinoma * Biliary tract cancer * Endometrial carcinoma * Cervical cancer * Ovarian cancer * Gastric or gastroesophageal cancer * Colorectal cancer * Non-small cell lung cancer Key Exclusion Criteria * 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.
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Get notified about this study
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
30 sites in 7 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Clinical Study Site
RECRUITINGBirmingham, Alabama, 35294, United States
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Clinical Study Site
RECRUITINGLos Angeles, California, 90033, United States
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Clinical Study Site
RECRUITINGDenver, Colorado, 80218, United States
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Clinical Study Site
RECRUITINGWashington D.C., District of Columbia, 20009, United States
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Clinical Study Site
RECRUITINGOrlando, Florida, 32827, United States
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Clinical Study Site
RECRUITINGSarasota, Florida, 34236, United States
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Clinical Study Site
RECRUITINGDetroit, Michigan, 48201, United States
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Clinical Study Site
RECRUITINGGrand Rapids, Michigan, 49546, United States
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Clinical Study Site
RECRUITINGNew York, New York, 10029, United States
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Clinical Study Site
RECRUITINGColumbus, Ohio, 43210, United States
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Clinical Study Site
RECRUITINGPittsburgh, Pennsylvania, 15232, United States
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Clinical Study Site
RECRUITINGNashville, Tennessee, 37203, United States
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Clinical Study Site
RECRUITINGDallas, Texas, 75230, United States
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Clinical Study Site
RECRUITINGSan Antonio, Texas, 78229, United States
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Clinical Study Site
RECRUITINGWest Valley City, Utah, 84119, United States
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Clinical Study Site
WITHDRAWNSouth Brisbane, Queensland, 4101, Australia
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Clinical Study Site
RECRUITINGDublin, Ireland, Ireland
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Clinical Study Site
RECRUITINGMilan, Milano, 20089, Italy
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Clinical Study Site
RECRUITINGCandiolo, Torino, 10060, Italy
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Clinical Study Site
RECRUITINGCluj-Napoca, Cluj, 400015, Romania
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Clinical Study Site
RECRUITINGBucharest, 022328, Romania
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Clinical Study Site
RECRUITINGSeoul, Seoul, 03080, South Korea
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Clinical Study Site
RECRUITINGSeoul, Seoul, 03722, South Korea
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Clinical Study Site
RECRUITINGSeoul, Seoul, 06351, South Korea
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Clinical Study Site
RECRUITINGSongpa-dong, Seoul, 05505, South Korea
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Clinical Study Site
RECRUITINGSeongnam-si, 13620, South Korea
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Clinical Study Site
RECRUITINGBarcelona, Barcelona, 08023, Spain
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Clinical Study Site
RECRUITINGLogroño, La Rioja, 26006, Spain
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Clinical Study Site
RECRUITINGMadrid, Madrid, 28040, Spain
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Clinical Study Site
RECRUITINGMadrid, Madrid, 28223, Spain
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Clinical Study Site
RECRUITINGManchester, Greater Manchester, M20 4 BX, United Kingdom
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Other studies related to the condition(s) this trial covers.
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