NCT04991740 is a Phase 1 clinical trial of JNJ-78306358 in Neoplasms, sponsored by Janssen Research & Development, LLC.

Who is sponsoring NCT04991740?

NCT04991740 is sponsored by Janssen Research & Development, LLC.

What drugs are being tested in NCT04991740?

Interventions in NCT04991740: JNJ-78306358.

Is NCT04991740 still recruiting?

NCT04991740 is currently completed. Last updated 24 March 2023.

Last reviewed 2023-03-24 · How we verify

NCT04991740

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of JNJ-78306358 in Participants With Advanced Stage Solid Tumors

Completed Phase 1 Last updated 24 March 2023

What this trial tests

Phase 1 trial testing JNJ-78306358 in Neoplasms in 39 participants. Completed in 9 February 2023.

Timeline

24 October 2021

Primary endpoint
9 February 2023

9 February 2023

Quick facts

Lead sponsor	Janssen Research & Development, LLC
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	39
Start date	24 October 2021
Primary completion	9 February 2023
Estimated completion	9 February 2023
Sites	5 locations across Israel, Spain

Drugs / interventions tested

JNJ-78306358 — full drug profile →

Conditions studied

Neoplasms — all drugs for Neoplasms →

Sponsor

Janssen Research & Development, LLC — full company profile →

Who can join

18 and older, any sex, with Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to determine the recommended phase 2 dose (RP2D) regimen(s) of JNJ-78306358 in Part 1 (Dose Escalation) and to determine the safety of JNJ-78306358 at the RP2D regimen(s) in Part 2 (Dose Expansion).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Emerging phagocytosis checkpoints in cancer immunotherapy.
Liu Y, Liu Y, Wang Y, Yang Y, et al · · 2023 · cited 186× · PMID 36882399 · DOI 10.1038/s41392-023-01365-z
T-Cell Engagers in Solid Cancers-Current Landscape and Future Directions.
Shanshal M, Caimi PF, Adjei AA, Ma WW. · · 2023 · cited 38× · PMID 37345160 · DOI 10.3390/cancers15102824
Harnessing the potential of HLA-G in cancer therapy: advances, challenges, and prospects.
Wang S, Wang J, Xia Y, Zhang L, et al · · 2024 · cited 31× · PMID 38310272 · DOI 10.1186/s12967-024-04938-w
HLA-G and Other Immune Checkpoint Molecules as Targets for Novel Combined Immunotherapies.
Morandi F, Airoldi I. · · 2022 · cited 26× · PMID 35328349 · DOI 10.3390/ijms23062925
HLA and tumour immunology: immune escape, immunotherapy and immune-related adverse events.
Jiang N, Yu Y, Wu D, Wang S, et al · · 2023 · cited 19× · PMID 36662304 · DOI 10.1007/s00432-022-04493-1
Clinical Progresses and Challenges of Bispecific Antibodies for the Treatment of Solid Tumors.
Gu Y, Zhao Q. · · 2024 · cited 16× · PMID 39172329 · DOI 10.1007/s40291-024-00734-w
Revolutionizing cancer immunotherapy: unleashing the potential of bispecific antibodies for targeted treatment.
Guo X, Wu Y, Xue Y, Xie N, et al · · 2023 · cited 15× · PMID 38106416 · DOI 10.3389/fimmu.2023.1291836
Safety and clinical activity of JNJ-78306358, a human leukocyte antigen-G (HLA-G) x CD3 bispecific antibody, for the treatment of advanced stage solid tumors.
Geva R, Vieito M, Ramon J, Perets R, et al · · 2024 · cited 11× · PMID 39105878 · DOI 10.1007/s00262-024-03790-7

Verify or expand the search:

Other recruiting trials for Neoplasms

Currently open trials in the same condition.

NCT07438782 — First Time in Human (FTIH) Study to Investigate the Safety and Preliminary Activity of GSK5533524 Alone or in Combinatio · Phase 1 · recruiting
NCT07382817 — Phase 1 Study of JV-394 Autologous Anti-CD94 CAR T for r/r CD94+ T/NK Cell Neoplasms · Phase 1 · recruiting
NCT07277270 — A Study of GSK5764227 in Combination With Standard of Care (SoC) or Other Agents in Participants With Advanced Solid Tum · Phase 1 · recruiting
NCT07257640 — IL-5 CAR-T Cell Therapy for Refractory/Relapsed Eosinophilic Leukemia · Phase 1 · recruiting
NCT07213609 — A Study to Investigate the Safety and Preliminary Efficacy of GSK5460025 Alone or in Combination With Other Anti-cancer · Phase 1, PHASE2 · recruiting

Other Janssen Research & Development, LLC trials

Trials by the same sponsor.

NCT07518186 — A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma · Phase 3 · not yet recruiting
NCT07309445 — A Study to Assess Real-World Use and Outcomes of TAR-200 for Participants With Non-Muscle Invasive Bladder Cancer (NMIBC · recruiting
NCT07499232 — A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease · Phase 3 · not yet recruiting
NCT07438496 — A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus · Phase 3 · recruiting
NCT07227025 — A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer · Phase 1, PHASE2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04991740 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Janssen Research & Development, LLC
Last refreshed: 24 March 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04991740.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing