CR-001 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
CR-001: Intravenous Infusion
Paclitaxel: Intravenous Infusion
trifluridine and tipiracil: Oral
Pemetrexed: Intravenous Infusion
Carboplatin: Intravenous Infusion
Oxaliplatin: Intravenous Infusion
Gemcitabin: Intravenous Infusion
Cisplatin: Intravenous Infusion
Capecitabine: Oral
FOLFOX: Intravenous Infusion + Oral
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
Primary outcome measure(s)
- Part 1 (Dose Escalation) - Incidence and nature of dose-limiting toxicities — From the first dose of study drug up until approximately 1 month
Per cohort - Part 1 (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
- Part 3 (Dose Expansion) - Overall response rate (ORR) by Investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) — From the first dose of study drug until 90 days after the last dose of study drug
Trial sites (34)
| 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 | Villejuif | France | Recruiting |
| Clinical Study Site | Dublin | Ireland | Recruiting |
| Clinical Study Site | Candiolo | Torino | Recruiting |
| Clinical Study Site | Florence | Italy | Recruiting |
| Clinical Study Site | Milan | Italy | Recruiting |
| Clinical Study Site | Cluj-Napoca | Cluj | Recruiting |
| Clinical Study Site | Bucharest | Romania | Recruiting |
| Clinical Study Site | Songpa-dong | Seoul | Recruiting |
| Clinical Study Site | Seongnam-si | South Korea | Recruiting |
| Clinical Study Site | Seoul | South Korea | Recruiting |
| Clinical Study Site | Seoul | South Korea | Recruiting |
| Clinical Study Site | Seoul | South Korea | Recruiting |
| Clinical Study Site | Logroño | La Rioja | Recruiting |
| Clinical Study Site | Barcelona | Spain | Recruiting |
| Clinical Study Site | Madrid | Spain | Recruiting |
| Clinical Study Site | Madrid | Spain | Recruiting |
| Clinical Study Site | Manchester | Greater Manchester | Recruiting |
| Clinical Study Site | London | United Kingdom | Recruiting |
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 France