NCT04496674: 2019-004849-32

Bispecific PSMAxCD3 Antibody CC-1 in Patients With Squamous Cell Carcinoma of the Lung

Terminated Phase 1, PHASE2 Last updated 23 April 2025

What this trial tests

Phase 1, PHASE2 trial testing CC-1 and Toczilizumab in Lung Cancer Squamous Cell in 3 participants. Terminated before completion.

Timeline

2 February 2022

Primary endpoint
3 May 2023

3 May 2023

Quick facts

Lead sponsor	German Cancer Research Center
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	3
Start date	2 February 2022
Primary completion	3 May 2023
Estimated completion	3 May 2023
Sites	2 locations across Germany

Drugs / interventions tested

• CC-1 and Toczilizumab — full drug profile →

Conditions studied

• Lung Cancer Squamous Cell — all drugs for Lung Cancer Squamous Cell →

Sponsor

German Cancer Research Center — full company profile →

Who can join

18 and older, any sex, with Lung Cancer Squamous Cell. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This trial is a phase I study in patients with metastatic non-small-cell lung cancer (NSCLC) after failure of second line therapy aiming to evaluate safety and efficacy of CC-1, a bispecific antibody (bsAb) with PSMAxCD3 specificity developed within DKTK. CC-1 binds to human prostate-specific membrane antigen (PSMA) on tumor cells of squamous cell carcinoma of the lung (SCC) as well as to tumor vessels of SCC, thereby allowing for a dual mode of anti-cancer action. CC-1 was developed in a novel format which not only prolongs serum half-life but most importantly reduces off-target T cell activation with expected fewer side effects. Together with preemptive IL-6 receptor (IL-6R) blockade using tocilizumab, this allows for application of effective bsAb doses with expected high anticancer activity. The study comprises two phases: The first phase is a dose-escalation phase with concomitant prophylactic application of tocilizumab to evaluate the maximally tolerated dose (MTD) of CC-1. This is followed by a dose-expansion phase (also with prophylactic IL-6R blockade using tocilizumab). A translational research program comprising, among others, analysis of CC-1 half-life and the induced immune response as well as molecular profiling in liquid biopsies will serve to better define the mode of action of CC-1 and to identify biomarkers for further clinical development.

Publications & conference data

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

1. T cells in health and disease.
   Sun L, Su Y, Jiao A, Wang X, et al · · 2023 · cited 717× · PMID 37332039 · DOI 10.1038/s41392-023-01471-y
2. Current landscape and future directions of bispecific antibodies in cancer immunotherapy.
   Wei J, Yang Y, Wang G, Liu M. · · 2022 · cited 127× · PMID 36389699 · DOI 10.3389/fimmu.2022.1035276
3. Overcoming Challenges for CD3-Bispecific Antibody Therapy in Solid Tumors.
   Middelburg J, Kemper K, Engelberts P, Labrijn AF, et al · · 2021 · cited 122× · PMID 33466732 · DOI 10.3390/cancers13020287
4. Recent advances and challenges of bispecific antibodies in solid tumors.
   Wu Y, Yi M, Zhu S, Wang H, et al · · 2021 · cited 64× · PMID 34922633 · DOI 10.1186/s40164-021-00250-1
5. The Landscape of Immunotherapy Resistance in NSCLC.
   Frisone D, Friedlaender A, Addeo A, Tsantoulis P. · · 2022 · cited 52× · PMID 35515125 · DOI 10.3389/fonc.2022.817548
6. Immune cell engagers in solid tumors: promises and challenges of the next generation immunotherapy.
   Fucà G, Spagnoletti A, Ambrosini M, de Braud F, et al · · 2021 · cited 41× · PMID 33508733 · DOI 10.1016/j.esmoop.2020.100046
7. An optimized IgG-based B7-H3xCD3 bispecific antibody for treatment of gastrointestinal cancers.
   Zekri L, Lutz M, Prakash N, Manz T, et al · · 2023 · cited 36× · PMID 36793213 · DOI 10.1016/j.ymthe.2023.02.010
8. Bispecific T-Cell Engagers Therapies in Solid Tumors: Focusing on Prostate Cancer.
   Simão DC, Zarrabi KK, Mendes JL, Luz R, et al · · 2023 · cited 35× · PMID 36900202 · DOI 10.3390/cancers15051412