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zeluvalimab (AMG 404)
i
Other names: AMG 404, AMG-404, AMG404
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News alerts, weekly reports and conference planners
Company:
Amgen
Drug class:
PD1 inhibitor
Related drugs:
1m
CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov)
P1, N=610, Active, not recruiting, Amgen | Recruiting --> Active, not recruiting | N=1200 --> 610 | Trial primary completion date: Jun 2026 --> Dec 2026
Enrollment closed • Enrollment change • Trial primary completion date
|
KRAS (KRAS proto-oncogene GTPase)
|
KRAS mutation • KRAS G12C • KRAS G12
|
Keytruda (pembrolizumab) • Mekinist (trametinib) • Tecentriq (atezolizumab) • Gilotrif (afatinib) • Ibrance (palbociclib) • carboplatin • paclitaxel • docetaxel • everolimus • Vectibix (panitumumab) • Lumakras (sotorasib) • pemetrexed • oxaliplatin • irinotecan • batoprotafib (TNO155) • vociprotafib (RMC-4630) • BI 1701963 • zeluvalimab (AMG 404)
7ms
A phase I, open-label, multicentre, first-in-human study to evaluate safety, pharmacokinetics and efficacy of AMG 404, a PD-1 inhibitor, in patients with advanced solid tumours. (PubMed, BMJ Open)
AMG 404 monotherapy was tolerable at the tested doses, with encouraging antitumour activity observed across tumour types.
P1 data • PK/PD data • Journal • MSi-H Biomarker • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability)
|
PD-L1 expression • MSI-H/dMMR
|
zeluvalimab (AMG 404)
9ms
CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov)
P1, N=1200, Recruiting, Amgen | Trial completion date: Mar 2028 --> Dec 2027
Trial completion date
|
KRAS (KRAS proto-oncogene GTPase)
|
KRAS mutation • KRAS G12C • KRAS G12
|
Keytruda (pembrolizumab) • Mekinist (trametinib) • Tecentriq (atezolizumab) • Gilotrif (afatinib) • Ibrance (palbociclib) • carboplatin • paclitaxel • docetaxel • everolimus • Vectibix (panitumumab) • Lumakras (sotorasib) • pemetrexed • oxaliplatin • irinotecan • batoprotafib (TNO155) • vociprotafib (RMC-4630) • BI 1701963 • zeluvalimab (AMG 404)
1year
Study of AMG 596 in Patients With EGFRvIII Positive Glioblastoma (clinicaltrials.gov)
P1, N=30, Terminated, Amgen | Completed --> Terminated; Amgen business decision
Trial termination • Combination therapy
|
etevritamab (AMG 596) • zeluvalimab (AMG 404)
1year
AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC) (clinicaltrials.gov)
P1, N=23, Completed, Amgen | Active, not recruiting --> Completed | Trial completion date: Jan 2025 --> Sep 2024
Trial completion • Trial completion date • Combination therapy
|
Imdelltra (tarlatamab-dlle) • zeluvalimab (AMG 404)
1year
CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov)
P1, N=1200, Recruiting, Amgen | Trial completion date: Jun 2029 --> Mar 2028 | Trial primary completion date: Jan 2027 --> Apr 2026
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
KRAS (KRAS proto-oncogene GTPase)
|
KRAS mutation • KRAS G12C • KRAS G12
|
Keytruda (pembrolizumab) • Mekinist (trametinib) • Tecentriq (atezolizumab) • Gilotrif (afatinib) • Ibrance (palbociclib) • carboplatin • paclitaxel • docetaxel • everolimus • Vectibix (panitumumab) • Lumakras (sotorasib) • pemetrexed • oxaliplatin • irinotecan • batoprotafib (TNO155) • vociprotafib (RMC-4630) • BI 1701963 • zeluvalimab (AMG 404)
1year
CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov)
P1, N=1200, Recruiting, Amgen | Trial completion date: Mar 2028 --> Jun 2029 | Trial primary completion date: Sep 2025 --> Jan 2027
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
KRAS (KRAS proto-oncogene GTPase)
|
KRAS mutation • KRAS G12C • KRAS G12
|
Keytruda (pembrolizumab) • Mekinist (trametinib) • Tecentriq (atezolizumab) • Gilotrif (afatinib) • Ibrance (palbociclib) • carboplatin • paclitaxel • docetaxel • everolimus • Vectibix (panitumumab) • Lumakras (sotorasib) • pemetrexed • oxaliplatin • irinotecan • batoprotafib (TNO155) • vociprotafib (RMC-4630) • BI 1701963 • zeluvalimab (AMG 404)
1year
AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC) (clinicaltrials.gov)
P1, N=23, Active, not recruiting, Amgen | Phase classification: P1b --> P1
Phase classification • Combination therapy
|
Imdelltra (tarlatamab-dlle) • zeluvalimab (AMG 404)
over1year
CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov)
P1, N=1200, Recruiting, Amgen | Trial primary completion date: Dec 2026 --> Sep 2025
Trial primary completion date • Combination therapy • Metastases
|
KRAS (KRAS proto-oncogene GTPase)
|
Keytruda (pembrolizumab) • Avastin (bevacizumab) • Mekinist (trametinib) • Tecentriq (atezolizumab) • Gilotrif (afatinib) • Ibrance (palbociclib) • carboplatin • paclitaxel • docetaxel • everolimus • Vectibix (panitumumab) • Lumakras (sotorasib) • pemetrexed • oxaliplatin • irinotecan • batoprotafib (TNO155) • vociprotafib (RMC-4630) • BI 1701963 • zeluvalimab (AMG 404)
over1year
CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov)
P1, N=1200, Recruiting, Amgen | Phase classification: P1/2 --> P1
Phase classification • Combination therapy • Metastases
|
KRAS (KRAS proto-oncogene GTPase)
|
Keytruda (pembrolizumab) • Avastin (bevacizumab) • Mekinist (trametinib) • Tecentriq (atezolizumab) • Gilotrif (afatinib) • Ibrance (palbociclib) • carboplatin • paclitaxel • docetaxel • everolimus • Vectibix (panitumumab) • Lumakras (sotorasib) • pemetrexed • oxaliplatin • irinotecan • batoprotafib (TNO155) • vociprotafib (RMC-4630) • BI 1701963 • zeluvalimab (AMG 404)
over1year
CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov)
P1/2, N=1126, Recruiting, Amgen | Trial primary completion date: Sep 2026 --> Dec 2026
Trial primary completion date • Combination therapy • Metastases
|
KRAS (KRAS proto-oncogene GTPase)
|
KRAS mutation • KRAS G12C • KRAS G12
|
Keytruda (pembrolizumab) • Avastin (bevacizumab) • Mekinist (trametinib) • Tecentriq (atezolizumab) • Gilotrif (afatinib) • Ibrance (palbociclib) • carboplatin • paclitaxel • docetaxel • everolimus • Vectibix (panitumumab) • Lumakras (sotorasib) • pemetrexed • oxaliplatin • irinotecan • batoprotafib (TNO155) • vociprotafib (RMC-4630) • BI 1701963 • zeluvalimab (AMG 404)
over1year
Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B Cell Precursor ALL (clinicaltrials.gov)
P1, N=17, Completed, Amgen | Phase classification: P1b --> P1
Phase classification • Combination therapy
|
Blincyto (blinatumomab) • dexamethasone injection • zeluvalimab (AMG 404)
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