NCT04937153 is a Phase 1 clinical trial of Acasunlimab in Solid Tumor, sponsored by Genmab.

Who is sponsoring NCT04937153?

NCT04937153 is sponsored by Genmab.

What drugs are being tested in NCT04937153?

Interventions in NCT04937153: Acasunlimab, Pembrolizumab.

What condition does NCT04937153 study?

NCT04937153 studies Solid Tumor.

Is NCT04937153 still recruiting?

NCT04937153 is currently completed. Last updated 16 July 2025.

Last reviewed 2025-07-16 · How we verify

NCT04937153

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

GEN1046 Safety and PK in Subjects With Advanced Solid Malignancies

Completed Phase 1 Last updated 16 July 2025

What this trial tests

Phase 1 trial testing Acasunlimab in Solid Tumor in 18 participants. Completed in 1 October 2024.

Timeline

15 June 2021

Primary endpoint
1 October 2024

1 October 2024

Quick facts

Lead sponsor	Genmab
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	15 June 2021
Primary completion	1 October 2024
Estimated completion	1 October 2024
Sites	2 locations across Japan

Drugs / interventions tested

Acasunlimab — full drug profile →
Pembrolizumab (pembrolizumab) — full drug profile →

Conditions studied

Solid Tumor — all drugs for Solid Tumor →

Sponsor

Genmab — full company profile →

Who can join

20 and older, any sex, with Solid Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary objective of the study is to evaluate the safety, tolerability, dose-limiting toxicity (DLT) and pharmacokinetics (PK) of acasunlimab (also known as GEN1046) administered as monotherapy or in combination with pembrolizumab in Japanese study participants with malignant solid tumors.

Publications & conference data

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

The emerging landscape of novel 4-1BB (CD137) agonistic drugs for cancer immunotherapy.
Claus C, Ferrara-Koller C, Klein C. · · 2023 · cited 65× · PMID 36727218 · DOI 10.1080/19420862.2023.2167189
The PD-L1/4-1BB Bispecific Antibody-Anticalin Fusion Protein PRS-344/S095012 Elicits Strong T-Cell Stimulation in a Tumor-Localized Manner.
Peper-Gabriel JK, Pavlidou M, Pattarini L, Morales-Kastresana A, et al · · 2022 · cited 44× · PMID 35121624 · DOI 10.1158/1078-0432.ccr-21-2762
Targeting Co-Stimulatory Receptors of the TNF Superfamily for Cancer Immunotherapy.
Müller D. · · 2023 · cited 24× · PMID 36571696 · DOI 10.1007/s40259-022-00573-3
Delivering co-stimulatory tumor necrosis factor receptor agonism for cancer immunotherapy: past, current and future perspectives.
Dadas O, Ertay A, Cragg MS. · · 2023 · cited 18× · PMID 37180119 · DOI 10.3389/fimmu.2023.1147467
Anti-PD-L1-Based Bispecific Antibodies Targeting Co-Inhibitory and Co-Stimulatory Molecules for Cancer Immunotherapy.
Geng Q, Jiao P. · · 2024 · cited 14× · PMID 38257366 · DOI 10.3390/molecules29020454
Acasunlimab, an Fc-inert PD-L1×4-1BB bispecific antibody, combined with PD-1 blockade potentiates antitumor immunity via complementary immune modulatory effects.
Capello M, Sette A, Plantinga T, Thalhauser CJ, et al · · 2025 · cited 9× · PMID 40216443 · DOI 10.1136/jitc-2024-011377
Targeting 4-1BB for tumor immunotherapy from bench to bedside.
Wang YT, Ji WD, Jiao HM, Lu A, et al · · 2022 · cited 6× · PMID 36189243 · DOI 10.3389/fimmu.2022.975926
Emerging cGAS-STING Agonist-Based Nanotherapeutics: Mechanistic Insights and Applications in Cancer Combination Therapy.
Wang Z, Wang Y, He Z, Liu C. · · 2025 · cited 5× · PMID 40842018 · DOI 10.1002/advs.202509890

Verify or expand the search:

Other trials of Acasunlimab

Trials testing the same drug.

NCT06984328 — Study of the Effectiveness and Safety of Acasunlimab Alone and With Pembrolizumab to Treat Advanced Melanoma of the Skin · Phase 2 · active not recruiting
NCT06635824 — Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non-Small Cel · Phase 3 · active not recruiting
NCT06046274 — GEN1046 in Combination With Anticancer Agents for the Treatment of Advanced Endometrial Cancer · Phase 2 · withdrawn
NCT05117242 — Safety and Efficacy Study of GEN1046 as a Single Agent or in Combination With Pembrolizumab for Treatment of Recurrent ( · Phase 2 · active not recruiting
NCT03917381 — GEN1046 Safety Trial in Patients With Malignant Solid Tumors · Phase 1, PHASE2 · active not recruiting

Other recruiting trials for Solid Tumor

Currently open trials in the same condition.

NCT07489378 — NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rar · recruiting
NCT07487597 — Functionally Enhanced ALPP-Targeted Engineered T Cells in Advanced Solid Tumors · EARLY_PHASE1 · recruiting
NCT07382544 — Phase 1b Trial of BMS-986504 in Combination With Olaparib in Patients With MTAP Loss · Phase 1 · recruiting
NCT07466160 — A Phase Ib/II Study of 7MW3711 Combined With JS207 in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
NCT07450560 — Research on Real-time Proton Therapy Guidance Through Monitoring Proton Range Using All-digital PET · active not recruiting

Other Genmab trials

Trials by the same sponsor.

NCT07416123 — A Study of GEN1106 in Participants With Solid Tumors · Phase 1 · recruiting
NCT07384715 — First-in-human (FIH) Trial of GEN3018 in Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) or Higher-risk Myelod · Phase 1 · recruiting
NCT07288177 — Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer · Phase 2 · recruiting
NCT06984328 — Study of the Effectiveness and Safety of Acasunlimab Alone and With Pembrolizumab to Treat Advanced Melanoma of the Skin · Phase 2 · active not recruiting
NCT06771921 — A First-in-Human Trial of Safety and Efficacy of GEN1078 in Participants With Solid Tumors · Phase 1, PHASE2 · terminated

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 NCT04937153 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 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 Genmab
Last refreshed: 16 July 2025

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/NCT04937153.

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