Health TrialsbyHealthPanel

A Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors

ConditionAdvanced Stage Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJanssen Research & Development, LLC

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • JNJ-95437446

    Drug

    JNJ-95437446 will be administered.

  • Amivantamab

    Drug

    Amivantamab will be administered.

Treatment groups

400 Participants
are divided into 1 treatment group
Group A: JNJ-95437446Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of Participants with Adverse Events (AEs) by Severity

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.

Time frame
Up to 2 years and 4 months
2

Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)

The DLTs are specific adverse events that includes high grade hematologic or non-hematologic toxicities with exceptions and/or toxicities leading to treatment discontinuation.

Time frame
Up to 21 days

Secondary outcomes

1

Objective Response Rate

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).

Time frame
Up to 2 years and 4 months
2

Duration of Response (DOR)

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.

Time frame
Up to 2 years and 4 months
3

Progression Free Survival (PFS)

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.

Time frame
Up to 2 years and 4 months
4

Maximum Plasma Concentration (Cmax) for JNJ-95437446

Serum samples will be analyzed to determine Cmax of JNJ-95437446 antibody-drug conjugate, total antibody, released payload and the payload's metabolite.

Time frame
Up to 2 years and 4 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Janssen Research & Development, LLC

Lead sponsor

Source ClinicalTrials.gov
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