Last reviewed 2026-04-23 · How we verify

mCapOX plus cetuximab

West China Hospital · Phase 3 active Small molecule

mCapOX plus cetuximab is a Platinum-based chemotherapy, EGFR inhibitor Small molecule drug developed by West China Hospital. It is currently in Phase 3 development for Metastatic colorectal cancer, Head and neck cancer.

mCapOX is a chemotherapy drug that works by inhibiting DNA replication, while cetuximab is a monoclonal antibody that targets the epidermal growth factor receptor (EGFR).

mCapOX is a chemotherapy drug that works by inhibiting DNA replication, while cetuximab is a monoclonal antibody that targets the epidermal growth factor receptor (EGFR). Used for Metastatic colorectal cancer, Head and neck cancer.

Likelihood of approval

61.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Oncology Phase 3 boost +3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	mCapOX plus cetuximab
Sponsor	West China Hospital
Drug class	Platinum-based chemotherapy, EGFR inhibitor
Target	EGFR
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

mCapOX is a platinum-based chemotherapy drug that forms platinum-DNA adducts, thereby inhibiting DNA replication and transcription. Cetuximab is a chimeric monoclonal antibody that binds to the extracellular domain of EGFR, preventing its activation and subsequent signaling pathways that promote cell proliferation and survival.

Approved indications

Metastatic colorectal cancer
Head and neck cancer

Common side effects

Diarrhea
Skin rash
Fatigue
Nausea and vomiting
Dermatitis acneiform
Mucositis
Anorexia
Weight loss
Hypomagnesemia
Hypokalemia

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

mCapOX plus cetuximab CI brief — competitive landscape report
mCapOX plus cetuximab updates RSS · CI watch RSS
West China Hospital portfolio CI

Frequently asked questions about mCapOX plus cetuximab

What is mCapOX plus cetuximab?

mCapOX plus cetuximab is a Platinum-based chemotherapy, EGFR inhibitor drug developed by West China Hospital, indicated for Metastatic colorectal cancer, Head and neck cancer.

How does mCapOX plus cetuximab work?

mCapOX is a chemotherapy drug that works by inhibiting DNA replication, while cetuximab is a monoclonal antibody that targets the epidermal growth factor receptor (EGFR).

What is mCapOX plus cetuximab used for?

mCapOX plus cetuximab is indicated for Metastatic colorectal cancer, Head and neck cancer.

Who makes mCapOX plus cetuximab?

mCapOX plus cetuximab is developed by West China Hospital (see full West China Hospital pipeline at /company/west-china-hospital).

What drug class is mCapOX plus cetuximab in?

mCapOX plus cetuximab belongs to the Platinum-based chemotherapy, EGFR inhibitor class. See all Platinum-based chemotherapy, EGFR inhibitor drugs at /class/platinum-based-chemotherapy-egfr-inhibitor.

What development phase is mCapOX plus cetuximab in?

mCapOX plus cetuximab is in Phase 3.

What are the side effects of mCapOX plus cetuximab?

Common side effects of mCapOX plus cetuximab include Diarrhea, Skin rash, Fatigue, Nausea and vomiting, Dermatitis acneiform, Mucositis.

What does mCapOX plus cetuximab target?

mCapOX plus cetuximab targets EGFR and is a Platinum-based chemotherapy, EGFR inhibitor.

Drug class: All Platinum-based chemotherapy, EGFR inhibitor drugs
Target: All drugs targeting EGFR
Manufacturer: West China Hospital — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Metastatic colorectal cancer
Indication: Drugs for Head and neck cancer

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing