Evidence map›Paper›PMID 33067297›Full record

ArticleBMJ open2020

Protocol of a prospective, multicentre phase I study to evaluate the safety, tolerability and preliminary efficacy of the bispecific PSMAxCD3 antibody CC-1 in patients with castration-resistant prostate carcinoma.

Jonas S Heitmann, Juliane S Walz, Martin Pflügler, Joseph Kauer, Richard F Schlenk, Gundram Jung, Helmut R Salih

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04104607 (First in Human Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of the Bispecific PSMAxCD3 Antibody CC-1 in Patients with Castration Resistant Prostate Carcinoma), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
0.9field-weighted citation impact, top 22% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04104607 phase1recruitingnot on this map

First in Human Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of the Bispecific PSMAxCD3 Antibody CC-1 in Patients with Castration Resistant Prostate Carcinoma

TypeinterventionalSponsorUniversity Hospital TuebingenRan2019 to 2025Enrolled86ConditionsCastration-Resistant Prostatic CancerArmsCC-1, PSMAxCD3
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 16 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Article
  5. Article
  6. Review
  7. Emerging Immunotherapy Approaches for Treating Prostate Cancer.International journal of molecular sciences · 2023
    Review
  8. An optimized IgG-based B7-H3xCD3 bispecific antibody for treatment of gastrointestinal cancers.Molecular therapy : the journal of the American Society of Gene Therapy · 2023
    Article
  9. Review
  10. Article
  11. Review
  12. Article
  13. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 1 country.

Jonas S HeitmannClinical Collaboration Unit Translational Immunology, German Cancer Consortium (DKTK), Department of Internal Medicine, University Hospital Tübingen, Tübingen, Germany.ORCID 0000-0002-7305-8620
Juliane S WalzClinical Collaboration Unit Translational Immunology, German Cancer Consortium (DKTK), Department of Internal Medicine, University Hospital Tübingen, Tübingen, Germany.
Martin PflüglerClinical Collaboration Unit Translational Immunology, German Cancer Consortium (DKTK), Department of Internal Medicine, University Hospital Tübingen, Tübingen, Germany.
Joseph KauerInstitute for Cell Biology, Department of Immunology, University of Tübingen, Tübingen, Germany.
Richard F Schlenk *National Center of Tumor Diseases-Trial Center, National Center of Tumor Diseases, German Cancer Research Center, Heidelberg, Germany.
Gundram Jung *Institute for Cell Biology, Department of Immunology, University of Tübingen, Tübingen, Germany.
Helmut R Salih *Clinical Collaboration Unit Translational Immunology, German Cancer Consortium (DKTK), Department of Internal Medicine, University Hospital Tübingen, Tübingen, Germany helmut.salih@med.uni-tuebingen.de.
Deutschen Konsortium für Translationale Krebsforschung · DEUniversity of Tübingen · DEGerman Cancer Research Center · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionProstate cancer is the second most common cancer in men worldwide. When the disease becomes resistant to androgen-deprivation therapy, treatment options are sparse. To address the high medical need in castration-resistant prostate cancer (CRPC), we generated a novel PSMAxCD3 bispecific antibody termed CC-1. CC-1 binds to prostate-specific membrane antigen that is expressed on prostate cancer cells and tumour vessels, thereby allowing a dual anticancer effect. METHODS AND ANALYSIS: This first in human clinical study is a prospective and multicentre trial which enrols patients with metastatic CRPC after failure of established third-line therapy. CC-1 is applied after prophylactic interleukin-6 receptor blockade with tocilizumab (once 8 mg/kg body weight). Each patient receives at least one cycle of CC-1 over a time course of 7 days in an inpatient setting. If clinical benefit is observed, up to five additional cycles of CC-1 can be applied. The study is divided in two parts: (1) a dose escalation phase with intraindividual dose increase from 28 µg to the target dose of 1156 µg based on a modified fast titration design by Simon ETHICS AND DISSEMINATION: The PSMAxCD3 study was approved by the Ethics Committee of The University Hospital Tübingen (100/2019AMG1) and the Paul-Ehrlich-Institut (3684/02). Clinical trial results will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBERS: ClinicalTrials.gov Registry (NCT04104607) and ClinicalTrials.eu Registry (EudraCT2019-000238-20).

Indexed as

CarcinomaProstatic Neoplasms, Castration-ResistantAndrogen AntagonistsCastrationClinical Trials, Phase I as TopicHumansMaleMulticenter Studies as TopicProspective StudiesAndrogen Antagonistsadult oncologyimmunologyurological tumours

Identifiers

PMID33067297
PMCPMC7569941
OpenAlexW3093340038

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.