NCT03529526

Study of the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Antitumor Activity of KN046 in Subjects With Advanced Solid Tumors

Status unknown Phase 1 Last updated 22 May 2018

What this trial tests

Phase 1 trial testing KN046 in Advanced Solid Tumors in 21 participants. Status unknown.

Timeline

21 May 2018

Primary endpoint
30 October 2019

30 March 2020

Quick facts

Lead sponsor	Alphamab (Australia) Co Pty Ltd.
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	21
Start date	21 May 2018
Primary completion	30 October 2019
Estimated completion	30 March 2020
Sites	1 location across Australia

Drugs / interventions tested

• KN046 — full drug profile →

Conditions studied

• Advanced Solid Tumors — all drugs for Advanced Solid Tumors →

Sponsor

Alphamab (Australia) Co Pty Ltd.

Who can join

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

Sponsor's own description

This is an open-label, multicenter, dose-escalation phase I study to assess the safety, tolerability and preliminary efficacy of KN046 in participants with all advanced solid tumors who are not able to have current standard anti-tumor therapies. The purpose of this study is to determine the maximum tolerated dose (MTD) or a biological effective dose (BED), to characterise the safety, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of KN046 as a single agent in adult participants with advanced solid tumors

Publications & conference data

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

1. Biology drives the discovery of bispecific antibodies as innovative therapeutics.
   Nie S, Wang Z, Moscoso-Castro M, D'Souza P, et al · · 2020 · cited 79× · PMID 33928225 · DOI 10.1093/abt/tbaa003
2. Phase I trial of KN046, a novel bispecific antibody targeting PD-L1 and CTLA-4 in patients with advanced solid tumors.
   Ma Y, Xue J, Zhao Y, Zhang Y, et al · · 2023 · cited 38× · PMID 37263673 · DOI 10.1136/jitc-2022-006654
3. Research and Clinical Landscape of Bispecific Antibodies for the Treatment of Solid Malignancies.
   Antonarelli G, Giugliano F, Corti C, Repetto M, et al · · 2021 · cited 30× · PMID 34577584 · DOI 10.3390/ph14090884
4. Bispecific Antibodies in Lung Cancer: A State-of-the-Art Review.
   Khosla AA, Jatwani K, Singh R, Reddy A, et al · · 2023 · cited 19× · PMID 37895932 · DOI 10.3390/ph16101461
5. Bispecific Antibodies: A Novel Approach for the Treatment of Solid Tumors.
   Liguori L, Polcaro G, Nigro A, Conti V, et al · · 2022 · cited 18× · PMID 36432631 · DOI 10.3390/pharmaceutics14112442
6. 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
7. Novel Bi-Specific Immuno-Modulatory Tribodies Potentiate T Cell Activation and Increase Anti-Tumor Efficacy.
   Passariello M, Yoshioka A, Takahashi K, Hashimoto SI, et al · · 2022 · cited 9× · PMID 35408827 · DOI 10.3390/ijms23073466
8. Evolving landscape and academic attitudes toward the controversies of global immuno-oncology trials.
   Xu C, Zhang S, Zhang Y, Tang SQ, et al · · 2021 · cited 4× · PMID 33544890 · DOI 10.1002/ijc.33503