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Cetuximab - Dose Escalation
Cetuximab - Dose Escalation is a Small molecule drug developed by Wugen, Inc.. It is currently in Phase 1 development.
Cetuximab is an epidermal growth factor receptor (EGFR) inhibitor used to treat various solid tumors, including non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). It is an antibody-based drug that works by inhibiting the EGFR erbB1 receptor.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Cetuximab - Dose Escalation |
|---|---|
| Sponsor | Wugen, Inc. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Clinical Study of MK-4716 in People With Certain Solid Tumors (MK-4716-001) (PHASE1)
- A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations. (PHASE1)
- A Study of ERAS-007 in Patients With Advanced Gastrointestinal Malignancies (PHASE1, PHASE2)
- A Dose Escalation/Expansion Study of ERAS-601 in Patients With Advanced or Metastatic Solid Tumors (PHASE1)
- BBO-11818 in Adult Subjects With KRAS Mutant Cancer (PHASE1)
- A Study to Evaluate INCB186748 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation (PHASE1)
- A First-in-human Study of BGB-53038, a Pan-KRAS Inhibitor, Alone or in Combinations in Participants With Advanced or Metastatic Solid Tumors With KRAS Mutations or Amplification (PHASE1)
- A Phase I/IIa Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AZD0022 as Monotherapy and in Combination With Anti-cancer Agents in Adult Participants With Tumours Harbouring a KRASG12D Mutation (PHASE1)
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:
- Cetuximab - Dose Escalation CI brief — competitive landscape report
- Cetuximab - Dose Escalation updates RSS · CI watch RSS
- Wugen, Inc. portfolio CI
Frequently asked questions about Cetuximab - Dose Escalation
What is Cetuximab - Dose Escalation?
Who makes Cetuximab - Dose Escalation?
What development phase is Cetuximab - Dose Escalation in?
Related
- Manufacturer: Wugen, Inc. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing