OncoMatch/Clinical Trials/NCT05999396
FIH, Bispecific CD276xCD3 Antibody CC-3 in Patients With Colorectal Cancer
Is NCT05999396 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Administration of CC-3 for colorectal cancer.
Treatment: Administration of CC-3 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Breast Carcinoma
Sarcoma
Penile Carcinoma
Biomarker criteria
Required: RAS wild-type
anti-EGFR mAb (the latter, if RAS-wild-type and left sided tumors)
Allowed: BRAF V600E
patients BRAF V600E mutation patients should have received: Cetuximab in combination with encorafenib in second- or third-line treatment
Allowed: MMR deficient
In case of MSI-high/dMMR tumors, patients should have received checkpoint inhibitor therapy and at least two further lines of therapy of that stated above.
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: cytotoxic chemotherapy (FOLFOX, FOLFIRI, FOLFOXIRI, TAS-102, regorafenib) — metastatic
Patients with progressing metastatic CRC who were previously treated with FOLFOX, FOLFIRI, FOLFOXIRI, TAS-102, or regorafenib
Must have received: anti-VEGFR monoclonal antibody — metastatic
if applicable in combination with anti-VEGFR monoclonal antibody (mAb)
Must have received: anti-EGFR monoclonal antibody — metastatic
anti-EGFR mAb (the latter, if RAS-wild-type and left sided tumors)
Must have received: checkpoint inhibitor
In case of MSI-high/dMMR tumors, patients should have received checkpoint inhibitor therapy and at least two further lines of therapy of that stated above.
Must have received: anti-EGFR monoclonal antibody (cetuximab) — second- or third-line
Cetuximab in combination with encorafenib in second- or third-line treatment
Must have received: BRAF inhibitor (encorafenib) — second- or third-line
Cetuximab in combination with encorafenib in second- or third-line treatment
Cannot have received: investigational anticancer therapy
Concurrent or previous treatment within 30 days in another interventional clinical trial with an investigational anticancer therapy
Cannot have received: systemic chemotherapy
Exception: within 2 weeks prior to study treatment
Patients receiving any systemic chemotherapy, mAb or radiotherapy within 2 (for mAb 4) weeks prior to study treatment or a longer period depending on the defined characteristics of the agents used
Cannot have received: monoclonal antibody
Exception: within 4 weeks prior to study treatment
Patients receiving any systemic chemotherapy, mAb or radiotherapy within 2 (for mAb 4) weeks prior to study treatment or a longer period depending on the defined characteristics of the agents used
Cannot have received: radiation therapy
Exception: within 2 weeks prior to study treatment
Patients receiving any systemic chemotherapy, mAb or radiotherapy within 2 (for mAb 4) weeks prior to study treatment or a longer period depending on the defined characteristics of the agents used
Lab requirements
Blood counts
Hemoglobin ≥ 9 g/dl (transfusion allowed); Neutrophil count ≥ 1,500/mm3; Platelet count ≥ 75,000/µl
Kidney function
Serum creatinine ≤ 1.5mg/dl or creatinine clearance ≥ 60ml/min
Liver function
Bilirubin ≤ 1.5x ULN (no hepatic mets), ≤ 2.5x ULN (with hepatic mets); ALT/AST ≤ 2.5x ULN (no hepatic mets), ≤ 5x ULN (with hepatic mets)
Adequate bone marrow, renal, and hepatic function defined by laboratory tests within 14 days prior to study treatment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify