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DRUG:

zeluvalimab (AMG 404)

i
Other names: AMG 404
Associations
Company:
Amgen
Drug class:
PD1 inhibitor
Related drugs:
Associations
7d
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)
24d
Phase classification • Combination therapy
|
Blincyto (blinatumomab) • dexamethasone injection • zeluvalimab (AMG 404)
5ms
AMG 404 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
P1, N=171, Completed, Amgen | Active, not recruiting --> Completed
Trial completion • Metastases
|
MSI-H/dMMR
|
zeluvalimab (AMG 404)
5ms
Trial primary completion date
|
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 • 5-fluorouracil • everolimus • Vectibix (panitumumab) • Lumakras (sotorasib) • pemetrexed • oxaliplatin • irinotecan • leucovorin calcium • batoprotafib (TNO155) • vociprotafib (RMC-4630) • BI 1701963 • zeluvalimab (AMG 404)
5ms
Phase classification
|
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 • 5-fluorouracil • everolimus • Vectibix (panitumumab) • Lumakras (sotorasib) • pemetrexed • oxaliplatin • irinotecan • leucovorin calcium • batoprotafib (TNO155) • vociprotafib (RMC-4630) • BI 1701963 • zeluvalimab (AMG 404)
6ms
Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC) (clinicaltrials.gov)
P1/2, N=65, Terminated, Amgen | Active, not recruiting --> Terminated; Amgen made a business decision to discontinue all AMG 160 clinical trials. This decision is not related to safety.
Trial termination • Metastases
|
Xtandi (enzalutamide capsule) • abiraterone acetate • acapatamab (AMG 160) • zeluvalimab (AMG 404)
6ms
Trial 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 • 5-fluorouracil • everolimus • Vectibix (panitumumab) • Lumakras (sotorasib) • pemetrexed • oxaliplatin • irinotecan • leucovorin calcium • batoprotafib (TNO155) • vociprotafib (RMC-4630) • BI 1701963 • zeluvalimab (AMG 404)
7ms
AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC) (clinicaltrials.gov)
P1b, N=23, Active, not recruiting, Amgen | Trial completion date: Jan 2026 --> Jan 2025
Trial completion date • Combination therapy
|
tarlatamab (AMG 757) • zeluvalimab (AMG 404)
7ms
Study of AMG 994 Monotherapy and AMG 994 and AMG 404 Combination Therapy in Participants With Advanced Solid Tumors (clinicaltrials.gov)
P1, N=11, Completed, Amgen | Active, not recruiting --> Completed | Trial completion date: Sep 2023 --> Jun 2023
Trial completion • Trial completion date • Combination therapy • Metastases
|
MSLN (Mesothelin)
|
MSLN expression • MSLN positive
|
inezetamab (AMG 994) • zeluvalimab (AMG 404)
8ms
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 • 5-fluorouracil • everolimus • Vectibix (panitumumab) • Lumakras (sotorasib) • pemetrexed • oxaliplatin • irinotecan • leucovorin calcium • batoprotafib (TNO155) • vociprotafib (RMC-4630) • BI 1701963 • zeluvalimab (AMG 404)
9ms
CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov)
P1b/2, N=1143, Recruiting, Amgen | Trial completion date: Jan 2029 --> Jul 2027 | Trial primary completion date: Jul 2026 --> Jan 2025
Trial completion date • 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 • 5-fluorouracil • everolimus • Vectibix (panitumumab) • Lumakras (sotorasib) • pemetrexed • oxaliplatin • irinotecan • leucovorin calcium • batoprotafib (TNO155) • vociprotafib (RMC-4630) • BI 1701963 • zeluvalimab (AMG 404)
10ms
AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC) (clinicaltrials.gov)
P1b, N=23, Active, not recruiting, Amgen | Trial completion date: Aug 2025 --> Jan 2026
Trial completion date • Combination therapy
|
tarlatamab (AMG 757) • zeluvalimab (AMG 404)
11ms
Study of AMG 994 Monotherapy and AMG 994 and AMG 404 Combination Therapy in Participants With Advanced Solid Tumors (clinicaltrials.gov)
P1, N=11, Active, not recruiting, Amgen | Trial completion date: Aug 2024 --> Sep 2023 | Trial primary completion date: Feb 2024 --> Jun 2023
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
MSLN (Mesothelin)
|
MSLN expression • MSLN positive
|
inezetamab (AMG 994) • zeluvalimab (AMG 404)
12ms
Enrollment change • Metastases
|
Xtandi (enzalutamide capsule) • abiraterone acetate • acapatamab (AMG 160) • zeluvalimab (AMG 404)
1year
CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov)
P1b/2, N=1143, Recruiting, Amgen | Trial completion date: Apr 2028 --> Jan 2029 | Trial primary completion date: Feb 2026 --> Jul 2026
Trial completion date • 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 • 5-fluorouracil • everolimus • Vectibix (panitumumab) • Lumakras (sotorasib) • pemetrexed • oxaliplatin • irinotecan • leucovorin calcium • 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)
P1b/2, N=1143, Recruiting, Amgen | Trial completion date: Jun 2027 --> Apr 2028 | Trial primary completion date: Dec 2024 --> Feb 2026
Trial completion date • 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 • 5-fluorouracil • everolimus • Vectibix (panitumumab) • Lumakras (sotorasib) • pemetrexed • oxaliplatin • irinotecan • leucovorin calcium • 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)
P1b/2, N=1143, Recruiting, Amgen | Trial completion date: Oct 2026 --> Jun 2027 | Trial primary completion date: Aug 2024 --> Dec 2024
Trial completion date • 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 • 5-fluorouracil • everolimus • Vectibix (panitumumab) • Lumakras (sotorasib) • pemetrexed • oxaliplatin • irinotecan • leucovorin calcium • batoprotafib (TNO155) • vociprotafib (RMC-4630) • BI 1701963 • zeluvalimab (AMG 404)
over1year
Study of AMG 994 Monotherapy and AMG 994 and AMG 404 Combination Therapy in Participants With Advanced Solid Tumors (clinicaltrials.gov)
P1, N=11, Active, not recruiting, Amgen | Trial completion date: Mar 2023 --> Aug 2024 | Trial primary completion date: Jan 2023 --> Feb 2024
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
MSLN (Mesothelin)
|
MSLN expression • MSLN positive
|
inezetamab (AMG 994) • zeluvalimab (AMG 404)
almost2years
Study of AMG 994 Monotherapy and AMG 994 and AMG 404 Combination Therapy in Participants With Advanced Solid Tumors (clinicaltrials.gov)
P1, N=11, Active, not recruiting, Amgen | Recruiting --> Active, not recruiting | N=214 --> 11 | Trial completion date: Aug 2025 --> Mar 2023 | Trial primary completion date: Feb 2025 --> Jan 2023
Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
|
MSLN (Mesothelin)
|
MSLN expression • MSLN positive
|
inezetamab (AMG 994) • zeluvalimab (AMG 404)
2years
CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov)
P1b/2, N=1054, Recruiting, Amgen | Trial completion date: Jan 2027 --> Aug 2026 | Trial primary completion date: Jan 2024 --> Aug 2024
Trial completion date • Trial primary completion date • Combination therapy
|
KRAS (KRAS proto-oncogene GTPase)
|
KRAS mutation • KRAS G12C • KRAS G12
|
Keytruda (pembrolizumab) • Avastin (bevacizumab) • Mekinist (trametinib) • Tecentriq (atezolizumab) • Gilotrif (afatinib) • Ibrance (palbociclib) • carboplatin • docetaxel • 5-fluorouracil • everolimus • Vectibix (panitumumab) • Lumakras (sotorasib) • pemetrexed • oxaliplatin • irinotecan • leucovorin calcium • batoprotafib (TNO155) • vociprotafib (RMC-4630) • loperamide • zeluvalimab (AMG 404)
2years
Trial primary completion date • Combination therapy
|
MSLN (Mesothelin)
|
MSLN expression • MSLN positive
|
inezetamab (AMG 994) • zeluvalimab (AMG 404)
over2years
Trial completion date • Combination therapy
|
KRAS (KRAS proto-oncogene GTPase)
|
KRAS mutation • KRAS G12C • KRAS G12
|
Keytruda (pembrolizumab) • Avastin (bevacizumab) • Mekinist (trametinib) • Tecentriq (atezolizumab) • Gilotrif (afatinib) • Ibrance (palbociclib) • carboplatin • docetaxel • 5-fluorouracil • everolimus • Vectibix (panitumumab) • Lumakras (sotorasib) • pemetrexed • oxaliplatin • irinotecan • leucovorin calcium • batoprotafib (TNO155) • vociprotafib (RMC-4630) • loperamide • zeluvalimab (AMG 404)
over2years
Study of AMG 994 Monotherapy and AMG 994 and AMG 404 Combination Therapy in Participants With Advanced Solid Tumors (clinicaltrials.gov)
P1, N=214, Recruiting, Amgen | Trial completion date: Oct 2024 --> Aug 2025 | Trial primary completion date: Oct 2024 --> Aug 2025
Clinical • Trial completion date • Trial primary completion date • Combination therapy
|
MSLN (Mesothelin)
|
MSLN expression • MSLN positive
|
inezetamab (AMG 994) • zeluvalimab (AMG 404)
over2years
Clinical • Trial completion date • Combination therapy
|
KRAS (KRAS proto-oncogene GTPase)
|
KRAS mutation • KRAS G12C • KRAS G12
|
Keytruda (pembrolizumab) • Avastin (bevacizumab) • Mekinist (trametinib) • Tecentriq (atezolizumab) • Gilotrif (afatinib) • Ibrance (palbociclib) • carboplatin • docetaxel • 5-fluorouracil • everolimus • Vectibix (panitumumab) • Lumakras (sotorasib) • pemetrexed • oxaliplatin • irinotecan • leucovorin calcium • batoprotafib (TNO155) • vociprotafib (RMC-4630) • loperamide • zeluvalimab (AMG 404)
almost3years
CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov)
P1b/2, N=1113, Recruiting, Amgen | Trial completion date: Nov 2025 --> Feb 2028 | Trial primary completion date: Jun 2023 --> Jan 2024
Clinical • Trial completion date • Trial primary completion date • Combination therapy • IO biomarker
|
KRAS (KRAS proto-oncogene GTPase)
|
KRAS mutation • KRAS G12C • KRAS G12
|
Keytruda (pembrolizumab) • Avastin (bevacizumab) • Mekinist (trametinib) • Tecentriq (atezolizumab) • Gilotrif (afatinib) • Ibrance (palbociclib) • carboplatin • docetaxel • 5-fluorouracil • everolimus • Vectibix (panitumumab) • Lumakras (sotorasib) • pemetrexed • oxaliplatin • irinotecan • leucovorin calcium • batoprotafib (TNO155) • vociprotafib (RMC-4630) • zeluvalimab (AMG 404)
almost3years
Clinical • Enrollment open • Combination therapy
|
MSLN (Mesothelin)
|
MSLN expression • MSLN positive
|
zeluvalimab (AMG 404)
3years
CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov)
P1b/2, N=1013, Recruiting, Amgen | Phase classification: P1b --> P1b/2 | Trial completion date: Jul 2027 --> Oct 2025
Clinical • Phase classification • Trial completion date • Combination therapy • IO biomarker
|
KRAS (KRAS proto-oncogene GTPase)
|
KRAS mutation • KRAS G12C • KRAS G12
|
Keytruda (pembrolizumab) • Avastin (bevacizumab) • Mekinist (trametinib) • Tecentriq (atezolizumab) • Gilotrif (afatinib) • Ibrance (palbociclib) • carboplatin • docetaxel • everolimus • Vectibix (panitumumab) • Lumakras (sotorasib) • pemetrexed • vociprotafib (RMC-4630) • zeluvalimab (AMG 404)
3years
Study of AMG 994 Monotherapy and AMG 994 and AMG 404 Combination Therapy in Participants With Advanced Solid Tumors (clinicaltrials.gov)
P1, N=214, Not yet recruiting, Amgen | Trial completion date: Jul 2024 --> Oct 2024 | Trial primary completion date: Jul 2024 --> Oct 2024
Clinical • Trial completion date • Trial primary completion date • Combination therapy
|
MSLN (Mesothelin)
|
MSLN expression • MSLN positive
|
zeluvalimab (AMG 404)
3years
CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov)
P1b, N=1003, Recruiting, Amgen | N=520 --> 1003 | Trial primary completion date: Jul 2027 --> May 2023
Clinical • Enrollment change • Trial primary completion date • Combination therapy • IO biomarker
|
KRAS (KRAS proto-oncogene GTPase)
|
KRAS mutation • KRAS G12C • KRAS G12
|
Keytruda (pembrolizumab) • Avastin (bevacizumab) • Mekinist (trametinib) • Tecentriq (atezolizumab) • Gilotrif (afatinib) • Ibrance (palbociclib) • carboplatin • docetaxel • everolimus • Vectibix (panitumumab) • Lumakras (sotorasib) • pemetrexed • vociprotafib (RMC-4630) • zeluvalimab (AMG 404)
over3years
CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov)
P1b, N=520, Recruiting, Amgen | Trial completion date: Aug 2026 --> Jul 2027 | Trial primary completion date: May 2026 --> Jul 2027
Clinical • Trial completion date • Trial primary completion date • Combination therapy • PD(L)-1 Biomarker • IO biomarker
|
KRAS (KRAS proto-oncogene GTPase)
|
KRAS mutation • KRAS G12C • KRAS G12
|
Keytruda (pembrolizumab) • Avastin (bevacizumab) • Mekinist (trametinib) • Tecentriq (atezolizumab) • Gilotrif (afatinib) • Ibrance (palbociclib) • carboplatin • docetaxel • everolimus • Vectibix (panitumumab) • Lumakras (sotorasib) • pemetrexed • vociprotafib (RMC-4630) • zeluvalimab (AMG 404)
almost4years
Clinical • Trial primary completion date • Combination therapy • PD(L)-1 Biomarker • IO biomarker
|
KRAS (KRAS proto-oncogene GTPase)
|
KRAS mutation • KRAS G12C • KRAS G12
|
Keytruda (pembrolizumab) • Avastin (bevacizumab) • Mekinist (trametinib) • Tecentriq (atezolizumab) • Gilotrif (afatinib) • Ibrance (palbociclib) • carboplatin • docetaxel • everolimus • Vectibix (panitumumab) • Lumakras (sotorasib) • pemetrexed • vociprotafib (RMC-4630) • zeluvalimab (AMG 404)
almost4years
CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov)
P1b, N=430, Recruiting, Amgen | N=250 --> 430 | Trial completion date: Jul 2024 --> Feb 2026
Clinical • Enrollment change • Trial completion date • Combination therapy • PD(L)-1 Biomarker • IO biomarker
|
KRAS (KRAS proto-oncogene GTPase)
|
KRAS mutation • KRAS G12C • KRAS G12
|
Keytruda (pembrolizumab) • Avastin (bevacizumab) • Mekinist (trametinib) • Tecentriq (atezolizumab) • Gilotrif (afatinib) • Ibrance (palbociclib) • carboplatin • docetaxel • everolimus • Vectibix (panitumumab) • Lumakras (sotorasib) • pemetrexed • vociprotafib (RMC-4630) • zeluvalimab (AMG 404)
4years
CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov)
P1b, N=250, Recruiting, Amgen | N=120 --> 250 | Trial completion date: Jan 2025 --> Jul 2024 | Trial primary completion date: Sep 2022 --> Apr 2022
Clinical • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • PD(L)-1 Biomarker • IO biomarker
|
KRAS (KRAS proto-oncogene GTPase)
|
KRAS mutation • KRAS G12C • KRAS G12
|
Keytruda (pembrolizumab) • Avastin (bevacizumab) • Mekinist (trametinib) • Tecentriq (atezolizumab) • Gilotrif (afatinib) • Ibrance (palbociclib) • carboplatin • docetaxel • everolimus • Vectibix (panitumumab) • Lumakras (sotorasib) • pemetrexed • vociprotafib (RMC-4630) • zeluvalimab (AMG 404)