NCT05999396 (CoRe_CC-3) is a Phase 1 clinical trial of Administration of CC-3 in Colorectal Cancer, sponsored by German Cancer Research Center.

Who is sponsoring NCT05999396?

NCT05999396 is sponsored by German Cancer Research Center.

What drugs are being tested in NCT05999396?

Interventions in NCT05999396: Administration of CC-3.

What condition does NCT05999396 study?

NCT05999396 studies Colorectal Cancer, Breast Carcinoma, Sarcoma, Penile Carcinoma.

Is NCT05999396 still recruiting?

NCT05999396 is currently recruiting now. Last updated 21 May 2025.

Last reviewed 2025-05-21 · How we verify

NCT05999396: CoRe_CC-3

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

FIH, Bispecific CD276xCD3 Antibody CC-3 in Patients With Colorectal Cancer

Recruiting now Phase 1 Last updated 21 May 2025

What this trial tests

Phase 1 trial testing Administration of CC-3 in Colorectal Cancer in 89 participants. Currently enrolling.

Timeline

12 January 2024

Primary endpoint
30 October 2026

31 March 2027

Quick facts

Lead sponsor	German Cancer Research Center
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	89
Start date	12 January 2024
Primary completion	30 October 2026
Estimated completion	31 March 2027
Sites	1 location across Germany

Drugs / interventions tested

Administration of CC-3 — full drug profile →

Conditions studied

Colorectal Cancer — all drugs for Colorectal Cancer →
Breast Carcinoma — all drugs for Breast Carcinoma →
Sarcoma — all drugs for Sarcoma →
Penile Carcinoma — all drugs for Penile Carcinoma →

Sponsor

German Cancer Research Center — full company profile →

Who can join

18 and older, any sex, with Colorectal Cancer or Breast Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This trial is a first in human (FIH) clinical trial in patients with Colorectal cancer (CRC) after failure of at least three lines of previous therapy aiming to evaluate safety and efficacy of CC-3, a bispecific antibody (bsAb) with CD276xCD3 specificity developed within DKTK. CC-3 binds to CD276 on cancer cells as well as to tumor vessels of CRC, thereby allowing for a dual mode of anti-cancer action. CC-3 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. A similar construct in this format with PSMAxCD3 specificity is presently undergoing clinical evaluation in patients with prostate cancer (NCT04104607), with very favorable safety and preliminary efficacy. The optimized format that CC-3 shares with its PSMAxCD3 "sister molecule" allows for application of effective bsAb doses with expected high anticancer activity. The clinical trial comprises two phases: The first phase is a dose-escalation part to evaluate the maximally tolerated dose (MTD) of CC-3. This is followed by a dose-expansion part to defined the recommended phase II dose. A translational research program comprising, among others, analysis of CC-3 half-life and the induced immune response will serve to better define the mode of action of CC-3.

Publications & conference data

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

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
Insights into next-generation immunotherapy designs and tools: molecular mechanisms and therapeutic prospects.
Qin H, Zhou Z, Shi R, Mai Y, et al · · 2025 · cited 15× · PMID 40483473 · DOI 10.1186/s13045-025-01701-6
Bispecific Antibodies in Solid Tumors: Advances and Challenges.
Shan KS, Musleh Ud Din S, Dalal S, Gonzalez T, et al · · 2025 · cited 12× · PMID 40565299 · DOI 10.3390/ijms26125838
Current and emerging concepts for systemic treatment of metastatic colorectal cancer.
Steup C, Kennel KB, Neurath MF, Fichtner-Feigl S, et al · · 2025 · cited 10× · PMID 41047178 · DOI 10.1136/gutjnl-2025-335412
The bispecific B7H3xCD3 antibody CC-3 induces T cell immunity against bone and soft tissue sarcomas.
Holzmayer SJ, Liebel K, Hagelstein I, Salih HR, et al · · 2024 · cited 8× · PMID 38765008 · DOI 10.3389/fimmu.2024.1391954
Emerging Immunotherapy Targets in Early Drug Development.
Morchón-Araujo D, Catani G, Mirallas O, Pretelli G, et al · · 2025 · cited 6× · PMID 40508202 · DOI 10.3390/ijms26115394
Targeting CD276 for T cell-based immunotherapy of breast cancer.
Hagelstein I, Wessling L, Rochwarger A, Zekri L, et al · · 2024 · cited 6× · PMID 39367484 · DOI 10.1186/s12967-024-05689-4
Protocol of a first-in-human clinical trial to evaluate the safety, tolerability, and preliminary efficacy of the bispecific CD276xCD3 antibody CC-3 in patients with colorectal cancer (CoRe_CC-3).
Jung S, Schlenk RF, Hackenbruch C, Roldan Pinzon SSL, et al · · 2024 · cited 4× · PMID 38410109 · DOI 10.3389/fonc.2024.1351901

Verify or expand the search:

Other recruiting trials for Colorectal Cancer

Currently open trials in the same condition.

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Other German Cancer Research Center trials

Trials by the same sponsor.

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NCT05494866 — A Trial of Cobicistat and Gemcitabine and Nab-Paclitaxel in Patients with Advanced Stage or Metastatic Pancreatic Ductal · Phase 1 · terminated
NCT06621810 — Artificial Intelligence Based Melanoma Early Diagnosis and Risk Prediction in Children, Adolescents and Young Adults · recruiting
NCT04410653 — Afatinib in Advanced NRG1-Rearranged Malignancies · Phase 2 · completed

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 NCT05999396 (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 German Cancer Research Center
Last refreshed: 21 May 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/NCT05999396.

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