RECRUITINGPhase 1INTERVENTIONAL
A Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors
A Phase 1 Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- Participants must have been previously diagnosed with diagnosed by tissue sample (biopsy-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
Who Should NOT Join This Trial:
- 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 willing to sign a consent form
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
JNJ-95437446
JNJ-95437446 will be administered.
Locations (8)
Florida Cancer Specialists
Sarasota, Florida, United States
NEXT Oncology
Fairfax, Virginia, United States
Severance Hospital Yonsei University Health System
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Hosp Univ Vall D Hebron
Barcelona, Spain
Hosp Univ Fund Jimenez Diaz
Madrid, Spain
Hosp. Univ. 12 de Octubre
Madrid, Spain
Hosp Univ Hm Sanchinarro
Madrid, Spain