A first-in-human study to evaluate the clinical activity of JNJ-63723283 in patients with advanced cancers.

Phase 1

• Conditions: Advanced Stage Solid Tumors; MedDRA version: 21.1Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-002017-22-IT
• Lead Sponsor: JANSSEN CILAG INTERNATIONAL NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-05
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 215

Inclusion Criteria

1. = 18 years of age
2. Have evaluable disease,
2a. For Part 2, at least 1 measurable lesion that can be accurately assessed at baseline by CT (or magnetic resonance imaging [MRI] where CT is contraindicated) and is suitable for repeated assessment as per RECIST v1.1
3. Type of cancer:
Part 1 of the study:
Has any type of advanced or refractory solid tumor malignancy, except lymphoma, that is metastatic or unresectable and previously received or was ineligible for standard treatment options including appropriate molecularly targeted therapies (eg, subjects with epidermal growth factor receptor [EGFR] mutant NSCLC or with NSCLC with anaplastic lymphoma tyrosine kinase [ALK] rearrangement).
Part 2 of the study:
Histologically or cytologically confirmed diagnosis of 1 of the following unresectable Stage III or IV solid tumor malignancies and previously received or was ineligible for standard treatment options including appropriate molecularly targeted therapies (eg, subjects with EGFR mutant NSCLC or with NSCLC with ALK rearrangement):
• NSCLC
• Bladder cancer (urothelial carcinoma)
• Renal cell carcinoma
• Gastric/esophageal carcinoma
• Melanoma
• SCLC
• MSI-H or dMMR CRC
• Thymoma, including thymic carcinoma
4. Have an Eastern Cooperative Oncology Group [ECOG] performance status 0 or 1
5. Have adequate organ and bone marrow function without blood product support.
6. Has thyroid function laboratory values within normal range. Note: If thyroid stimulating hormone (TSH) is not within normal limits, the subject may still be eligible if total T3 (either total or free) and free T4 are within normal limits.
7. Women of childbearing potential must have a negative serum pregnancy test at Screening using highly sensitive pregnancy test.
8. Willing to use contraceptive methods consistent with local regulations for subjects participating in clinical studies during and after the study until 5 months after the last dose of study drug.
a. Women of childbearing potential must agree to use 2 highly effective methods of contraception consistent with local regulations (<1% per year failure rate when used consistently and correctly).
b. A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control.
c. Women and men must agree not to donate sperm or eggs (ova, oocytes), respectively, during the study and after the study until 5 months after the last dose of study drug.
9. Willing and able to adhere to the prohibitions and restrictions specified in this protocol.
10. Each subject (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study. Consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part of standard of care for the subject’s disease.
11. Subjects enrolled into Part 2 must have tumor tissue available for correlative studies. Fresh tumor biopsy is preferred. Archival tissue must meet the following criteria: archival sections within 4 months of sectioning that have been stored at 2° to 8° C in the dark or archival tumor blocks within 5 years of collection. Subjects without tissues meeting the aforementioned archived tissue criteria must undergo a fresh biopsy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years

Exclusion Criteria

1. Has uncontrolled intercurrent illness, including but not limited to ongoing or active infection requiring IV antibiotics, symptomatic congestive heart failure (New York Heart Association class III-IV; Attachment 2), unstable angina pectoris, cardiac arrhythmia, poorly controlled hypertension or diabetes, or psychiatric illness/social situation that would limited compliance with study requirements
2. Has had prior treatment with an anti-PD-1 antibody, anti-PD-L1 antibody or anti-PD-L2 antibody
3. Treatment with any local or systemic anti-neoplastic therapy, radiotherapy (excluding limited palliative radiation), or investigational anticancer agent within 14 days or 4 half-lives, whichever is longer, up to a maximum wash-out period of 28 days prior to the initiation of study drug administration.
4. Has brain or leptomeningeal metastases unless asymptomatic
5. Has not recovered (ie, =Grade 1 or baseline) from AEs except alopecia, peripheral neuropathy related to prior anticancer therapy and stable anemia (ie, untransfused Hb =8.5 g/dL without the need for supportive transfusion within 2 weeks of screening) at the time of treatment allocation
6. Has an active autoimmune disease or a documented history of autoimmune disease that requires systemic steroids or immunosuppressive agents
7. Grade 3 or higher toxicity effects from previous treatment with immunotherapy
8. Known allergies, hypersensitivity, or intolerance to protein-based therapies or with a history of any significant drug allergy (such as anaphylaxis, hepatotoxicity, or immune-mediated thrombocytopenia or anemia), or to JNJ-63723283 excipients (refer to Investigator's Brochure)
9. Has taken immunosuppressive doses of systemic medications, such as corticosteroids (doses >10 mg/day prednisone or equivalent), within 2 weeks before the planned first dose of study drug
10. A woman who is pregnant, breast-feeding, or planning to become pregnant while enrolled in this study or within 5 months after the last dose of study drug
11. A man who plans to father a child while enrolled in this study or within 5 months after the last dose of study drug.
12. Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
13. Had major surgery (eg, requiring general anesthesia) within 4 weeks before dosing, or will not have fully recovered from surgery, or has surgery planned during the time the subject is expected to participate in the study or within 4 weeks after the last dose of study drug administration.
14. Active or chronic hepatitis B or hepatitis C disease as determined by hepatitis B surface antigen (HBsAg), hepatitis B core antibody, or hepatitis C antibody (anti-HCV) positivity at screening. If positive, further testing of quantitative levels to rule out active infection is required.
15. Has a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at Screening
16. Vaccinated with a live vaccine within 28 days (with the exception of the annual inactivated influenza vaccine) prior to the first dose of study drug. Annual inactivated influenza vaccine is permitted

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified