Clinical Trials in Spain / NCT07107230
Recruiting
Phase 1
A Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors
NCT07107230 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Advanced Stage Solid Tumors
Investigational drug(s) / intervention(s)
JNJ-95437446Amivantamab →
JNJ-95437446: JNJ-95437446 will be administered.
Amivantamab: Amivantamab will be administered.
Study summary
The purpose of this study is to determine recommended phase 2 doses (RP2Ds) of JNJ-95437446 in Part 1, and to further evaluate the safety of the RP2Ds in participants with advanced solid tumors in Part 2.
Eligibility
Inclusion Criteria:
* Participants must have been previously diagnosed with histologically confirmed unresectable, locally advanced, or metastatic non-small cell lung cancer, colorectal carcinoma, or head and neck squamous cell carcinoma
* Participants with non-small cell lung cancer (NSCLC) adenocarcinoma and colorectal cancer (CRC) must have local molecular testing to determine epidermal growth factor receptor (EGFR) mutational status for NSCLC and Kirsten rat sarcoma/neuroblastoma ras viral oncogene/v-raf murine sarcoma oncogene B1 (KRAS/NRAS/BRAF) mutation status for CRC
* Have measurable or evaluable disease:
* Part 1: Either measurable or evaluable disease; Part 2: At least 1 measurable lesion per response evaluation criteria in solid tumors (RECIST) version (v) 1.1
* Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1 at screening
* Participants must have appropriate hematologic, renal, and hepatic function within the required limits
Exclusion Criteria:
* Any prior medical history of ILD/pneumonitis, including pneumonitis from anti-PD-1/ PD-L1 antibody or radiation that required systemic steroids
* Toxicity from prior anticancer therapy that has not resolved to Grade \<=1
* Evidence of clinically significant active viral, bacterial, or fungal infection within 7 days before the first dose of study treatment requiring systemic or non-topical treatment
* History of clinically significant cardiovascular disease within 6 months prior to signing informed consent
* Participants with prior or concurrent second malignancy cannot be enrolled if prior/concurrent malignancy's natural history of treatment is likely to interfere with any safety or efficacy study endpoints
Primary outcome measure(s)
- Number of Participants with Adverse Events (AEs) by Severity — Up to 2 years and 4 months
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product and does not necessarily have a causal relationship with the intervention. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. - Part 1: Number of Participants with Dose-Limiting Toxicity (DLT) — Up to 21 days
The DLTs are specific adverse events that includes high grade hematologic or non-hematologic toxicities with exceptions and/or toxicities leading to treatment discontinuation.
Trial sites (10)
| Facility | City | Region | Status |
|---|---|---|---|
| Florida Cancer Specialists | Sarasota | Florida | Recruiting |
| Columbia University Medical Center Herbert Irving Pavilion | New York | New York | Recruiting |
| Tennessee Oncology | Nashville | Tennessee | Recruiting |
| NEXT Oncology | Fairfax | Virginia | Recruiting |
| Severance Hospital Yonsei University Health System | Seoul | South Korea | Recruiting |
| Samsung Medical Center | Seoul | South Korea | Recruiting |
| Hosp Univ Vall D Hebron | Barcelona | Spain | Recruiting |
| Hosp Univ Fund Jimenez Diaz | Madrid | Spain | Recruiting |
| Hosp. Univ. 12 de Octubre | Madrid | Spain | Recruiting |
| Hosp Univ Hm Sanchinarro | Madrid | Spain | Recruiting |
More Janssen Research & Development, LLC trials in Spain
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 NCT07107230 on ClinicalTrials.gov ↗ ← All trials in Spain