A First-in-Human, Open-label, Phase 1/2 Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Subjects with Advanced Cancers

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Janssen - Cilag International

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

6 Dec 2016 → ongoing

Decision date (initial)

2024-07-22

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2023-506144-16-00

EudraCT number

2016-002017-22

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response, Safety, Pharmacokinetic, Efficacy, Others, Pharmacodynamic

To identify the RP2D(s) for JNJ-63723283 (Part 1), To assess the anti-tumor activity of JNJ-63723283 at the RP2D(s) in subjects with selected advanced cancers including NSCLC, melanoma, renal, bladder, SCLC, gastric/esophageal cancer, and MSI-H or dMMR CRC (Part 2), To determine a SC RP2D as defined by a dose regimen for JNJ-63723283 SC delivery which achieves similar exposure as with JNJ-63723283 IV delivery at the RP2Ds for IV administration (Part 3 and Part 4)

Conditions and MedDRA coding

Advanced Stage Solid Tumors

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. 1. Parts 1-4: Have an Eastern Cooperative Oncology Group [ECOG] performance status 0 or 1
2. 2. Parts 1-4: Has thyroid function laboratory values within normal range
3. 3. Parts 1-4: Females of childbearing potential must have a negative serum pregnancy test
4. 4.Parts 1-4: Willing and able to adhere to the prohibitions and restrictions specified in this protocol
5. 5. Participant must have evaluable disease. For Part 2 only: Participants 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 degree to 8 degree Celsius in the dark or archival tumor blocks within 5 years of collection. Participants without tissues meeting the aforementioned archived tissue criteria must undergo a fresh biopsy
6. 6. Parts 1 to 4: Have evaluable disease

Exclusion criteria 5

1. 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), unstable angina pectoris, cardiac arrhythmia, poorly controlled hypertension or diabetes, or psychiatric illness/social situation that would limited compliance with study requirements
2. 2. Has had prior treatment with an anti-Programmed-cell death receptor-1 (PD-1) antibody, anti-the ligand to programmed-cell death 1 (PD-L1) antibody or anti-the ligand to programmed-cell death 2 (PD-L2) antibody
3. 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. 4. Grade 3 or higher toxicity effects from previous treatment with immunotherapy
5. 5. A female 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Frequency and severity of DLT (Part 1); Overall response rate per the RECIST version 1.1 in subjects with selected advanced solid tumors (Part 2); JNJ-63723283 PK parameters after 1st dose administration as observed in Part 3 and JNJ-63723283 PK parameters after 4th dose as observed during Q3W dosing in Part 4

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Janssen - Cilag International

Sponsor organisation

Janssen - Cilag International

Address

Turnhoutseweg 30

City

Beerse

Postcode

2340

Country

Belgium

Scientific contact point

Organisation

Janssen - Cilag International

Contact name

CTIS Point of Contact

Public contact point

Organisation

Janssen - Cilag International

Contact name

CTIS Point of Contact

Third parties 3

Locations

2 EU/EEA countries · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 16 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications