Phase 1/2 Study of CR-001 Safety and Dose Finding in Adults with Locally Advanced or Metastatic Solid Tumors

1 1

What is this study about?

The study focuses on adults who have Locally Advanced or Metastatic Solid Tumors, which are cancers that have grown large or spread to other parts of the body. The investigational medicine being tested is called CR-001, which is given by IV infusion, meaning it is delivered directly into a vein through a small needle.

The main goal of the trial is to learn how safe the medicine is and how well patients can tolerate increasing doses. Participants will receive the drug in a series of treatment cycles that last about four weeks each, with the amount of medicine gradually increased in early groups to find the highest dose that can be given without unacceptable side effects.

During the study, patients will have regular check‑ups, blood tests, and scans to watch for any side effects and to see how the cancer responds. Any problems that arise will be recorded and managed by the medical team, and the study will continue until the predetermined number of treatment cycles is completed or if a participant chooses to stop early.

1 enrollment confirmation

after joining the study, a written agreement confirming participation is completed.

this document records that the participant understands the purpose, procedures, and possible risks of the trial.

2 baseline assessments

initial medical evaluation is performed, including review of medical history, physical examination, and laboratory tests such as blood work.

imaging studies are obtained to document the extent of the locally advanced or metastatic solid tumor.

these results establish a reference point for later comparison.

3 first dose administration

the investigational medicine, cr-001, is given by iv infusion (a medication delivered directly into a vein).

the exact amount of the drug is determined by the dose level assigned to the participant’s cohort; dose levels are increased in later cohorts if safety criteria are met.

the infusion is scheduled to occur on day 1 of a 28‑day treatment cycle.

4 monitoring during cycle 1

for the first 28 days after the initial infusion, the participant is observed for any dose‑limiting toxicities (serious side effects that would prevent dose increase).

regular clinic visits include physical checks, blood tests, and assessment of any adverse events (unwanted effects).

the study team records the nature and severity of any events using the standard grading system.

5 subsequent dosing

if no dose‑limiting toxicities occur, additional infusions of cr-001 are given on day 1 of each subsequent 28‑day cycle.

the participant continues this schedule for as long as the treatment is considered safe and beneficial.

6 dose escalation (for later cohorts)

in later groups of participants, the amount of cr-001 may be increased according to a predefined plan, provided earlier participants tolerated lower doses.

each new dose level follows the same 28‑day cycle and monitoring procedures.

7 dose expansion

once a safe and effective dose is identified, additional participants receive that recommended dose in an expanded cohort.

the administration schedule remains an iv infusion on day 1 of each 28‑day cycle.

8 ongoing safety and efficacy assessments

throughout treatment, periodic laboratory tests, physical examinations, and imaging studies are performed to evaluate safety and tumor response.

the study measures pharmacokinetics (how the drug moves through the body) and pharmacodynamics (the drug’s effects on the tumor).

any new or worsening adverse events are recorded and may lead to dose adjustments or discontinuation of treatment.

9 post‑treatment follow‑up

after the final infusion, the participant continues to be monitored at scheduled intervals for disease status and long‑term safety.

follow‑up visits may include imaging to assess tumor size and additional blood tests to detect possible antibodies against the drug.

Who Can Join the Study?

Be able to understand what the study involves and sign a written informed consent form.
Wait the required time after any previous cancer treatment:
- At least 3 weeks (or the time it takes for the drug to halve five times) after the last dose of any cancer‑fighting medicine.
- At least 28 days after the last radiation treatment; a short‑term (palliative) radiation is allowed if it does not treat the tumor being studied.
- At least 14 days after any surgery and be fully recovered from that surgery.
Agree not to donate sperm or eggs, and not to breast‑feed, from the first dose of the study drug until 120 days after the last dose.
Agree to use birth control as required:
- Women who can become pregnant must have a negative pregnancy test and use at least one highly effective method of contraception from the start of screening until 120 days after the last dose.
- Men who have not had a vasectomy and have a partner who can become pregnant must use a condom and ensure their partner also uses a highly effective method of contraception for the same time period.
Be at least 18 years old (or meet the legal age for consent in your country).
Have cancer that is advanced, cannot be removed by surgery, or has spread, and for which standard treatments are no longer working or are not suitable. The cancer must be one of the following types:
- Advanced liver cancer (certain subtypes excluded).
- Advanced biliary tract cancer (cancers of the bile ducts or gallbladder).
- Advanced or recurrent endometrial (uterine) cancer (certain rare subtypes excluded).
- Advanced or recurrent cervical cancer (certain rare subtypes excluded).
- Platinum‑resistant ovarian, fallopian tube, or primary peritoneal cancer (cancers that did not respond to standard platinum chemotherapy).
- Metastatic gastric (stomach) cancer with a specific protein test (PD‑L1 CPS ≥ 1).
- Metastatic colon or rectal cancer.
- Advanced or metastatic non‑small‑cell lung cancer with a specific protein test (PD‑L1 TPS ≥ 1%).
If you are in a back‑fill or dose‑optimization group, you must be willing to provide a recent tumor sample (from a stored biopsy or a new, low‑risk biopsy). Providing a sample is preferred but not required for the initial dose‑escalation group.
Have at least one tumor that can be measured on scans according to the RECIST v1.1 guidelines (a standard way doctors track tumor size).
Have a life expectancy of at least 3 months.
Have an ECOG performance status of 0 or 1, meaning you are fully active (0) or able to carry out light work (1).
Have laboratory test results that show adequate organ function, including:
- Liver enzymes (AST, ALT) not too high.
- Normal bilirubin level.
- Albumin level at least 2.8 g/dL.
- Normal blood clotting test (INR) unless you are on blood thinners.
- Kidney function (GFR) of at least 50 mL/min.
- Urine protein low (less than 2+ on dipstick).
- Cholesterol and triglycerides within acceptable limits.
- Blood counts: neutrophils ≥ 1.5 × 10⁹/L, platelets ≥ 100 × 10⁹/L, hemoglobin ≥ 9 g/dL, without needing transfusions or growth‑factor drugs for at least 7 days.
Be willing and able to attend scheduled study visits, follow‑up visits, and follow the treatment plan throughout the study.

Who Cannot Join the Study?

Has other cancers (malignancies) diagnosed within the past 3 years, except low‑risk ones such as early skin cancer, localized prostate cancer, or carcinoma in situ that are being watched without treatment.
Has had a serious immune‑related adverse event (grade ≥ 3) from a previous immunotherapy that caused that treatment to be stopped.
Has a history of non‑infectious lung inflammation (pneumonitis or interstitial lung disease) that required steroid medication, or currently has this lung problem (radiation‑related scarring is allowed).
Has a current severe infection that is not controlled; you may join after antibiotics or antifungals are finished and the infection is stable for at least 2 weeks.
Received a live or attenuated vaccine within 30 days before the first dose of the study drug.
Previously had an allogeneic stem‑cell transplant or a solid organ transplant.
Has an active hepatitis B infection (positive surface antigen) or hepatitis C infection with detectable virus in the blood.
Has HIV infection with a detectable viral load, AIDS‑related illness in the past 6 months, or a CD4+ T‑cell count below 350 cells/mm³.
Has any medical or psychological condition that the investigator believes would prevent participation, place you at high risk, or make study results difficult to interpret.
Imaging shows the tumor surrounds major blood vessels or has large dead tissue (necrosis) or cavities that could cause bleeding.
Has recent serious gastrointestinal problems, including: a) abdominal or throat fistula, perforation, or abscess within 6 months; b) blockage needing tube feeding or IV nutrition; c) non‑healing wounds, active ulcers, or untreated bone fractures; d) free air in the abdomen not due to recent surgery; e) coughing up a teaspoon or more of bright red blood or major GI bleeding within 6 months; f) bleeding disorders not caused by blood‑thinning medication.
Requires high‑dose systemic steroids (more than 10 mg prednisone‑equivalent per day) or other strong immune‑suppressing drugs within 7 days of the first dose (stable low doses for hormone replacement are allowed).
Has significant heart or blood‑vessel disease, such as uncontrolled high blood pressure (systolic > 150 mmHg or diastolic > 100 mmHg), history of hypertensive crisis, myocarditis or cardiomyopathy, major vascular disease (e.g., aortic aneurysm surgery, arterial clot, or serious blood clot), heart attack or unstable chest pain within 6 months, heart failure class II or higher, prolonged QT interval (>480 ms) or conditions that lengthen QT, serious heart rhythm problems needing medication, stroke or transient ischemic attack within 12 months, or left‑ventricular ejection fraction below 50%.
Has not recovered sufficiently from recent major surgery (excluding placement of a line for blood access).
Still has significant side effects from previous cancer treatment that have not returned to mild (grade ≤ 1) or baseline at least 14 days before starting the study, unless those side effects are stable and well‑controlled (e.g., hair loss, nerve tingling, hormone issues).
Is allergic or sensitive to any component of the study drug CR‑001.
For certain study groups only: previously received experimental PD‑(L)1/VEGF bispecific antibodies or other investigational immune‑checkpoint inhibitors that are not standard care for the cancer.
Has uncontrolled fluid buildup such as pleural effusion (around the lungs), pericardial effusion (around the heart), or ascites (in the abdomen) that requires drainage more than once a month; stable drains are allowed.
Has active cancer spread to the brain or spinal cord (central nervous system metastases). Treated, stable brain metastases may be allowed under specific conditions; untreated brain metastases are not allowed.
Has an active autoimmune disease that needs systemic treatment (such as disease‑modifying drugs, steroids, or other immune‑suppressing medicines) within the past 2 years; hormone replacement therapy is permitted.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
IRCCS Humanitas Research Hospital	Rozzano	Italy
Comite Entreprise Paul Papin	Angers	France
Institut Gustave Roussy	Villejuif	France
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS	Candiolo	Italy
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Ctkysr Lilt Bvqiqe	Lyon	France
Umgscpvdtk Hkqqtymbv Pevdv Srmtmkzbigp Cszulcb Feax	Paris	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	01.07.2026
Italy	Not yet recruiting	01.07.2026

Trial locations

CR-001 is an experimental medicine being tested for the first time in people with solid cancers that have spread or grown locally. In this study, the drug is given through an IV infusion, which means it is slowly delivered directly into a vein. The main goal is to see how safe the medicine is at different dose levels and how well the body handles it. Researchers will also look at how the drug moves through the body, how it affects cancer cells, and whether it shows any signs of shrinking tumors. Participants receive the drug in a controlled, step‑by‑step way so doctors can closely monitor any side effects and determine the best dose to use in future trials.

Locally advanced or metastatic solid tumor – A solid tumor is a lump of abnormal cells that forms in organs or tissues such as the breast, lung, or colon. When the tumor grows beyond its original location but has not yet spread to distant organs, it is described as locally advanced. If cancer cells break away and travel through the bloodstream or lymph system to form new tumors in other parts of the body, it is called metastatic. In both stages, the tumor can continue to enlarge, causing pain, swelling, or interference with normal organ function. Over time, the number of affected sites may increase, leading to more widespread involvement. The disease course is marked by gradual progression of tumor size and spread unless intervened.

Trial ID:

2025-523590-42-00

Protocol code:

CR-001-101

NCT ID:

NCT07335497

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

Other Trials to Consider

#1 Clinical Trials Search in Europe

Phase 1/2 Study of CR-001 Safety and Dose Finding in Adults with Locally Advanced or Metastatic Solid Tumors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?