Clinical Trials in Italy / NCT07335497
Recruiting
Phase 1/2
CR-001 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
NCT07335497 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Locally Advanced / Metastatic Solid Tumors
Investigational drug(s) / intervention(s)
CR-001
CR-001: Intravenous Infusion
Study summary
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.
Eligibility
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.
Primary outcome measure(s)
- Dose Escalation - Incidence and nature of dose-limiting toxicities — From the first dose of study drug up until approximately 1 month
Per cohort - Dose Escalation - Characterization of the maximum tolerated dose, if applicable — From the first dose of study drug up until approximately 1 month
Per Cohort - All parts - Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and treatment - emergent serious adverse events — From the first dose of study drug until 90 days after the last dose of study drug
Events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) - All parts - Incidence and severity of TEAEs leading to dose modifications — From the first dose of study drug until 90 days after the last dose of study drug
- All parts - Incidence and severity of TEAEs leading to treatment discontinuation — From the first dose of study drug until 90 days after the last dose of study drug
Trial sites (31)
| Facility | City | Region | Status |
|---|---|---|---|
| Clinical Study Site | Birmingham | Alabama | Recruiting |
| Clinical Study Site | Los Angeles | California | Recruiting |
| Clinical Study Site | Denver | Colorado | Recruiting |
| Clinical Study Site | Washington D.C. | District of Columbia | Recruiting |
| Clinical Study Site | Orlando | Florida | Recruiting |
| Clinical Study Site | Sarasota | Florida | Recruiting |
| Clinical Study Site | Detroit | Michigan | Recruiting |
| Clinical Study Site | Grand Rapids | Michigan | Recruiting |
| Clinical Study Site | New York | New York | Recruiting |
| Clinical Study Site | Columbus | Ohio | Recruiting |
| Clinical Study Site | Pittsburgh | Pennsylvania | Recruiting |
| Clinical Study Site | Nashville | Tennessee | Recruiting |
| Clinical Study Site | Dallas | Texas | Recruiting |
| Clinical Study Site | San Antonio | Texas | Recruiting |
| Clinical Study Site | West Valley City | Utah | Recruiting |
| Clinical Study Site | South Brisbane | Queensland | Withdrawn |
| Clinical Study Site | Dublin | Ireland | Recruiting |
| Clinical Study Site | Milan | Milano | Recruiting |
| Clinical Study Site | Candiolo | Torino | Recruiting |
| Clinical Study Site | Cluj-Napoca | Cluj | Recruiting |
| Clinical Study Site | Bucharest | Romania | Recruiting |
| Clinical Study Site | Seoul | Seoul | Recruiting |
| Clinical Study Site | Seoul | Seoul | Recruiting |
| Clinical Study Site | Seoul | Seoul | Recruiting |
| Clinical Study Site | Songpa-dong | Seoul | Recruiting |
| Clinical Study Site | Seongnam-si | South Korea | Recruiting |
| Clinical Study Site | Barcelona | Barcelona | Recruiting |
| Clinical Study Site | Logroño | La Rioja | Recruiting |
| Clinical Study Site | Madrid | Madrid | Recruiting |
| Clinical Study Site | Madrid | Madrid | Recruiting |
| Clinical Study Site | Manchester | Greater Manchester | Recruiting |
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07335497 on ClinicalTrials.gov ↗ ← All trials in Italy