Drugs / Amivantamab
Amivantamab
also known as
Ami-HC · Ami-HC-CF · Ami-LC · amivantamab-vmjw · CNTO-4424 · JNJ 61186372 · JNJ-611 · JNJ-6372 · +1 more
Monoclonal antibody targets EGFR, MET
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Rybrevant | — | 2021-12-09 | europa.eu ↗ |
Trials 42 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT06632236 | Oct 2024 → Mar 2026 overdue | brain glioblastoma, diffuse glioma, H3 G34 mutant | Institute of Cancer Research, United Kingdom | Recruiting | No outcome recorded |
| Phase 1 | NCT06507306 | Jun 2024 → Jul 2026 overdue | cancer | Kumquat Biosciences Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT05395052 | May 2022 → Aug 2023 | breast cancer, colorectal cancer, gastroesophageal cancer, head and neck cancer +3 | Fate Therapeutics | Terminated | No outcome recorded |
| Phase 1 | NCT04606381 | Nov 2020 → Jul 2024 overdue | neoplasm | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04077463 | Sep 2019 → Feb 2027 expected | non-small cell lung carcinoma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02609776 | May 2016 → Dec 2026 expected | non-small cell lung carcinoma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 1/28 trials | ||||||
| Phase 1/2 | NCT07227025 | Mar 2026 → Nov 2028 expected | non-small cell lung carcinoma | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06532032 | Jul 2024 → Apr 2026 | non-small cell lung carcinoma | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1/2 | NCT06083857 | Jun 2024 → Dec 2027 expected | non-small cell lung carcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT06385080 | Apr 2024 → Dec 2032 expected | head and neck squamous cell carcinoma | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05845671 | Jul 2023 → Jan 2027 expected | non-small cell lung carcinoma | University of Colorado, Denver | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05908734 | May 2023 → Jan 2027 expected | non-small cell lung carcinoma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05488314 | Dec 2022 → Jun 2026 overdue | non-small cell lung carcinoma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05379595 | Jul 2022 → Apr 2027 expected | colorectal cancer | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 220 trials | ||||||
| Phase 2 | NCT07586202 | Jul 2026 → Mar 2028 expected | non-small cell lung carcinoma | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 2 | NCT07507188 | Apr 2026 → Jan 2031 expected | non-small cell lung carcinoma | Yonsei University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07062354 | Mar 2026 → Oct 2028 expected | head and neck squamous cell carcinoma | SWOG Cancer Research Network | Enrolling by invitation | No outcome recorded |
| Phase 2 | NCT07042295 | Mar 2026 → Feb 2029 expected | skin squamous cell carcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT07392658 | Dec 2025 → Oct 2027 expected | non-small cell lung carcinoma | Fondazione Ricerca Traslazionale | Recruiting | No outcome recorded |
| Phase 2 | NCT06855849 | May 2025 → May 2027 expected | colorectal cancer | Yonsei University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06667076 | Dec 2024 → May 2029 expected | non-small cell lung carcinoma | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 2 | NCT06116682 | Nov 2024 → May 2028 expected | non-small cell lung carcinoma | SWOG Cancer Research Network | Recruiting | No outcome recorded |
| Phase 2 | NCT06784791 | Nov 2024 → Jul 2027 expected | non-small cell lung carcinoma | University Hospital, Essen | Recruiting | No outcome recorded |
| Phase 2 | NCT05801029 | Jul 2023 → Oct 2027 expected | non-small cell lung carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05299125 | May 2023 → Jan 2026 overdue | non-small cell lung carcinoma | Latin American Cooperative Oncology Group | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05845450 | May 2023 → May 2026 overdue | colorectal carcinoma | Gruppo Oncologico del Nord-Ovest | Recruiting | No outcome recorded |
| Phase 2 | NCT05601973 | Mar 2023 → Aug 2024 overdue | non-small cell lung carcinoma | ETOP IBCSG Partners Foundation | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05653427 | Dec 2022 → Oct 2023 | hepatocellular carcinoma | Janssen Research & Development, LLC | Terminated | No outcome recorded |
| Phase 2 | NCT05498428 | Nov 2022 → Aug 2027 expected | non-small cell lung carcinoma | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 2 | NCT05074940 | Aug 2022 → Mar 2026 overdue | salivary gland cancer | Trisha Wise-Draper | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05117931 | Dec 2021 → Nov 2026 expected | gastroesophageal cancer | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04965090 | Sep 2021 → Dec 2025 | non-small cell lung carcinoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT04945733 | Aug 2021 → Jul 2023 | gastric neoplasm, neoplasm of esophagus | Janssen Pharmaceutical K.K. | Terminated | No outcome recorded |
| Phase 2 | NCT03767075 | Dec 2018 → May 2025 overdue | neoplasm | Vall d'Hebron Institute of Oncology | Recruiting | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT07276399 | Dec 2025 → Jun 2029 expected | head and neck squamous cell carcinoma | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT06750094 | Dec 2024 → Dec 2027 expected | colorectal neoplasm | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT06662786 | Oct 2024 → Dec 2028 expected | colorectal cancer | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT05388669 | Aug 2022 → Jan 2024 overdue | non-small cell lung carcinoma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04988295 | Nov 2021 → Jul 2023 overdue | non-small cell lung carcinoma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04538664 | Oct 2020 → May 2023 overdue | non-small cell lung carcinoma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04487080 | Sep 2020 → Aug 2023 overdue | non-small cell lung carcinoma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04599712 | — | non-small cell lung carcinoma | Janssen Research & Development, LLC | Approved for marketing | No outcome recorded |
Also used as a comparator or background therapy in 4 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT06816992 Background | Feb 2025 → Dec 2026 expected | non-small cell lung carcinoma | ORIC Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT06120140 Background | Feb 2024 → May 2027 expected | non-small cell lung carcinoma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05663866 Background | May 2023 → Mar 2024 overdue | non-small cell lung carcinoma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT07469488 Background | Apr 2026 → Aug 2029 expected | non-small cell lung carcinoma, toxic dermatosis, venous thromboembolism | Shanghai Pulmonary Hospital, Shanghai, China | Not yet recruiting | No outcome recorded |
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 52 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Amivantamab | “Only for amivantamab + lazertinib therapy, per CSCO guidelines and physician judgment.” NCT07469488 ↗45“Participants will receive amivantamab SC infusion.” NCT04606381 ↗ |
| Known as | Ami-HC | “Participants will receive SC infusion of newly developed high concentration amivantamab (Ami-HC) or SC injection of amivantamab co-formulated with rHuPH20 (Ami-HC-CF).” NCT04606381 ↗ |
| Known as | Ami-HC-CF | “Participants will receive SC infusion of newly developed high concentration amivantamab (Ami-HC) or SC injection of amivantamab co-formulated with rHuPH20 (Ami-HC-CF).” NCT04606381 ↗ |
| Known as | Ami-LC | “Participants in cohort 1a will receive amivantamab admixed with rHuPH20 (Ami-LC-MD) subcutaneous (SC) infusion and participants in cohort 1b will receive amivantamab (Ami-LC)...” NCT04606381 ↗ |
| Known as | amivantamab-vmjw | “The FDA granted accelerated approval for amivantamab-vmjw (hereafter referred to as amivantamab), a bispecific antibody directed against EGFR and mesenchymal-epithelial...” PMID 37022784 ↗ Sep 2023 |
| Known as | CNTO-4424 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297774 ↗ |
| Known as | JNJ 61186372 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297774 ↗ |
| Known as | JNJ-611 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297774 ↗ |
| Known as | JNJ-6372 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297774 ↗ |
| Known as | RYBREVANT | “This part of the CHRYSALIS study (called cohort D) investigated the bispecific antibody amivantamab (brand name RYBREVANT®) in patients with non-small-cell lung cancer (NSCLC)...” PMID 37589131 ↗ Aug 2023 |
| Action | Inhibit | “Amivantamab: Treating EGFR Exon 20-Mutant Cancers With Bispecific Antibody-Mediated Receptor Degradation.” PMID 34339261 ↗ Aug 2021 |
| Modality | Monoclonal antibody | “Amivantamab, an EGFR-MET bispecific antibody with immune cell-directing activity” PMID 34339292 ↗ Aug 2021 |
| Route | Intravenous | “1050 mg administered IV for body weight \< 80 kg and 1400 mg for body weight \>= 80 kg mg once weekly in Cycle 1 (with a split dose on Days 1-2) and then every 2 weeks in...” NCT03767075 ↗ |
| Target | EGFR | “Amivantamab, an epidermal growth factor receptor (EGFR)-c-Met bispecific antibody, targets activating/resistance EGFR mutations and MET mutations/amplifications.” PMID 35963523 ↗ Aug 2022 |
| Target | MET | “Amivantamab, an epidermal growth factor receptor (EGFR)-c-Met bispecific antibody, targets activating/resistance EGFR mutations and MET mutations/amplifications.” PMID 35963523 ↗ Aug 2022 |