Advanced Stage Solid Tumors
Conditions
Brief 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.
Interventions
DRUGJNJ-95437446
JNJ-95437446 will be administered.
DRUGAmivantamab
Amivantamab will be administered.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | Up to 2 years and 4 months | Objective response rate (ORR) is defined as the percentage of participants who have best response of complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST). |
| Duration of Response (DOR) | Up to 2 years and 4 months | DOR is defined for the responders from the date of initial documentation of a response to the date of first documented evidence of disease progression according to RECIST version (v.) 1.1, or death due to any cause, whichever occurs first. |
| Progression Free Survival (PFS) | Up to 2 years and 4 months | PFS is defined as the time from the first dose of JNJ-95437446 to either progressive disease (PD) or death due to any cause, whichever comes first. |
| Area Under the Plasma Concentration - Time (AUC [0-t]) Curve for JNJ-95437446 Antibody-Drug Conjugate, Total Antibody, Released Payload and the Payload's Metabolite | Up to 2 years and 4 months | AUC (0-t) defined as area under the plasma concentration-time curve during a dosing interval of JNJ-95437446 antibody-drug conjugate, total antibody, released payload and the payload's metabolite will be reported. |
| Maximum Plasma Concentration (Cmax) for JNJ-95437446 | Up to 2 years and 4 months | Serum samples will be analyzed to determine Cmax of JNJ-95437446 antibody-drug conjugate, total antibody, released payload and the payload's metabolite. |
| Number of Participants With Anti JNJ-95437446 Antibodies | Up to 2 years and 4 months | Serum samples will be analyzed for the detection of anti-JNJ-95437446 antibodies using a validated assay method. |
| Time to Reach Cmax (Tmax) for JNJ-95437446 | Up to 2 years and 4 months | Tmax defined as the the time to reach maximum observed plasma concentration of JNJ-95437446 antibody-drug conjugate, total antibody, released payload and the payload's metabolite will be reported. |
Countries
South Korea, Spain, United States
Contacts
CONTACTStudy Contact
Outcome results
None listed