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DRUG:

pimurutamab (HLX07)

i
Other names: HLX07, HLX-07
Company:
Fosun Pharma
Drug class:
EGFR inhibitor
Related drugs:
4ms
New P2 trial • Metastases
|
BRAF (B-raf proto-oncogene)
|
Hetronifly (serplulimab) • pimurutamab (HLX07)
5ms
Phase II Clinical Study to Compare the Efficacy and Safety of HLX07 + Serplulimab +Chemotherapy Versus Placebo + Serplulimab + Chemotherapy in First-Line Treatment of Patients With Recurrent or Metastatic NPC (clinicaltrials.gov)
P2, N=75, Active, not recruiting, Shanghai Henlius Biotech | Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2024 --> Sep 2024
Enrollment closed • Trial primary completion date • Metastases
|
cisplatin • Hetronifly (serplulimab) • pimurutamab (HLX07)
over1year
HLX07Ib/II: The Safety,Efficacy of Anti-EGFR Humanized Monoclonal Antibody Combined With Chemotherapy in Advanced Solid Tumors. (clinicaltrials.gov)
P1/2, N=56, Completed, Shanghai Henlius Biotech | Active, not recruiting --> Completed | N=90 --> 56
Trial completion • Enrollment change • Metastases
|
PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • IL2RA (Interleukin 2 receptor, alpha) • TNFRSF9 (TNF Receptor Superfamily Member 9)
|
cisplatin • carboplatin • gemcitabine • paclitaxel • 5-fluorouracil • oxaliplatin • leucovorin calcium • pimurutamab (HLX07)
almost2years
Evaluate the Efficacy and Safety of HLX10 in Combination With HLX07 in Patients With Advanced Head and Neck Tumors (clinicaltrials.gov)
P2, N=131, Active, not recruiting, Shanghai Henlius Biotech | N=56 --> 131 | Trial completion date: Oct 2023 --> Jun 2025 | Trial primary completion date: Dec 2022 --> May 2024
Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
|
PD-L1 expression
|
cisplatin • carboplatin • 5-fluorouracil • Hetronifly (serplulimab) • pimurutamab (HLX07)
2years
A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 Combination Therapy or Monotherapy in Patients With Advanced ESCC (clinicaltrials.gov)
P2, N=60, Recruiting, Shanghai Henlius Biotech | Active, not recruiting --> Recruiting | Initiation date: Jun 2019 --> Aug 2022
Enrollment open • Trial initiation date • Combination therapy
|
EGFR (Epidermal growth factor receptor)
|
EGFR expression
|
cisplatin • 5-fluorouracil • Hetronifly (serplulimab) • pimurutamab (HLX07)
over2years
A Study to Evaluate the Efficacy and Safety of HLX07 in nsqNSCLC Patients With High EGFR Expression (clinicaltrials.gov)
P2, N=60, Not yet recruiting, Shanghai Henlius Biotech | Initiation date: Jun 2022 --> Feb 2023
Trial initiation date
|
EGFR (Epidermal growth factor receptor)
|
EGFR expression • EGFR overexpression
|
carboplatin • docetaxel • pemetrexed • pimurutamab (HLX07)
over2years
Evaluate the Efficacy and Safety of HLX10 in Combination With HLX07 in Patients With Advanced Head and Neck Tumors (clinicaltrials.gov)
P2, N=56, Active, not recruiting, Shanghai Henlius Biotech | Trial primary completion date: May 2022 --> Dec 2022
Trial primary completion date • Combination therapy
|
PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
|
PD-L1 expression • EGFR mutation
|
Hetronifly (serplulimab) • pimurutamab (HLX07)
over2years
A Study of HLX07 + HLX10 With or Without Chemotherapy Versus HLX10 With Chemotherapy in First Line sqNSCLC (clinicaltrials.gov)
P2, N=156, Recruiting, Shanghai Henlius Biotech | Trial completion date: Oct 2023 --> Oct 2024
Trial completion date
|
EGFR (Epidermal growth factor receptor)
|
albumin-bound paclitaxel • Hetronifly (serplulimab) • pimurutamab (HLX07)
over2years
A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 Combination Therapy or Monotherapy in Patients With Advanced ESCC (clinicaltrials.gov)
P2, N=60, Active, not recruiting, Shanghai Henlius Biotech | Not yet recruiting --> Active, not recruiting | Initiation date: Aug 2022 --> Jun 2019
Enrollment closed • Trial initiation date • Combination therapy
|
EGFR (Epidermal growth factor receptor)
|
EGFR expression
|
cisplatin • 5-fluorouracil • Hetronifly (serplulimab) • pimurutamab (HLX07)
over2years
Trial initiation date
|
KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene)
|
BRAF wild-type
|
5-fluorouracil • oxaliplatin • leucovorin calcium • Hetronifly (serplulimab) • pimurutamab (HLX07)
over2years
HLX07+HLX10+Chemotherapy or HLX07 Monotherapy in Patients With Advanced Metastatic Gastric Cancer (clinicaltrials.gov)
P2, N=40, Recruiting, Shanghai Henlius Biotech | Not yet recruiting --> Recruiting
Enrollment open
|
HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
|
HER-2 negative • PD-L1 negative
|
capecitabine • oxaliplatin • Hetronifly (serplulimab) • pimurutamab (HLX07)
over2years
A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 Combination Therapy or Monotherapy in Patients With Advanced ESCC (clinicaltrials.gov)
P2, N=60, Not yet recruiting, Shanghai Henlius Biotech | Trial completion date: Apr 2023 --> Aug 2025 | Initiation date: Mar 2022 --> Aug 2022 | Trial primary completion date: Dec 2022 --> Jun 2024
Trial completion date • Trial initiation date • Trial primary completion date • Combination therapy
|
EGFR (Epidermal growth factor receptor)
|
EGFR expression
|
cisplatin • 5-fluorouracil • Hetronifly (serplulimab) • pimurutamab (HLX07)
almost3years
New P2 trial
|
HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
|
HER-2 negative • PD-L1 negative
|
capecitabine • oxaliplatin • Hetronifly (serplulimab) • pimurutamab (HLX07)
almost3years
New P2 trial
|
KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene)
|
BRAF wild-type
|
Hetronifly (serplulimab) • pimurutamab (HLX07)
almost3years
New P2 trial • Combination therapy
|
EGFR (Epidermal growth factor receptor)
|
EGFR expression
|
cisplatin • 5-fluorouracil • Hetronifly (serplulimab) • pimurutamab (HLX07)
almost3years
Enrollment open • Combination therapy
|
EGFR (Epidermal growth factor receptor)
|
albumin-bound paclitaxel • Hetronifly (serplulimab) • pimurutamab (HLX07)
almost3years
A phase 2 study of serplulimab plus HLX07 in patients with advanced head and neck tumours (ECHNO-ICHNO 2022)
No TEAEs leading to permanent discontinuation of study drugs or death were reported. Conclusion The results above demonstrated a manageable safety profile and encouraging efficacy of serplulimab plus HLX07 in patients with R/M HNSCC who had failed platinum-based chemotherapy, supporting a new treatment option that warrants further investigations.
Clinical • P2 data
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Hetronifly (serplulimab) • pimurutamab (HLX07)
almost3years
New P2 trial • Combination therapy
|
EGFR (Epidermal growth factor receptor)
|
EGFR expression • EGFR overexpression
|
docetaxel • pimurutamab (HLX07)
almost3years
HLX07Ib/II: The Safety,Efficacy of Anti-EGFR Humanized Monoclonal Antibody Combined With Chemotherapy in Advanced Solid Tumors. (clinicaltrials.gov)
P1/2, N=90, Active, not recruiting, Shanghai Henlius Biotech | Trial completion date: Oct 2021 --> Dec 2022 | Trial primary completion date: Sep 2021 --> Sep 2022
Clinical • Trial completion date • Trial primary completion date
|
PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • IL2RA (Interleukin 2 receptor, alpha) • TNFRSF9 (TNF Receptor Superfamily Member 9)
|
cisplatin • carboplatin • gemcitabine • paclitaxel • oxaliplatin • leucovorin calcium • pimurutamab (HLX07)
3years
Evaluate the Efficacy and Safety of HLX10 in Combination With HLX07 in Patients With Advanced Head and Neck Tumors (clinicaltrials.gov)
P2, N=56, Active, not recruiting, Shanghai Henlius Biotech | Not yet recruiting --> Active, not recruiting
Clinical • Enrollment closed • Combination therapy
|
PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
|
PD-L1 expression • EGFR mutation
|
Hetronifly (serplulimab) • pimurutamab (HLX07)
3years
HLX07Ib/II: The Safety,Efficacy of Anti-EGFR Humanized Monoclonal Antibody Combined With Chemotherapy in Advanced Solid Tumors. (clinicaltrials.gov)
P1/2, N=90, Active, not recruiting, Shanghai Henlius Biotech | Recruiting --> Active, not recruiting
Clinical • Enrollment closed
|
PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • IL2RA (Interleukin 2 receptor, alpha) • TNFRSF9 (TNF Receptor Superfamily Member 9)
|
cisplatin • carboplatin • gemcitabine • paclitaxel • oxaliplatin • leucovorin calcium • pimurutamab (HLX07)
over3years
Clinical • New P2 trial • Combination therapy
|
EGFR (Epidermal growth factor receptor)
|
albumin-bound paclitaxel • Hetronifly (serplulimab) • pimurutamab (HLX07)
over3years
Phase I first-in-human study of HLX07, a novel and improved recombinant anti-EGFR humanized monoclonal antibody, in patients with advanced solid cancers. (PubMed, Invest New Drugs)
Anti-HLX07 antibodies were not detected in any patients. Conclusion HLX07 was well tolerated (at dose levels up to 800 mg/week) and promising in patients with advanced solid cancers.Clinical Trial Registration: The study was registered at ClinicalTrials.gov : NCT02648490 (Jan 7, 2016).
Clinical • P1 data • Journal
|
KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene)
|
pimurutamab (HLX07)
over4years
Clinical • New P2 trial • Combination therapy
|
PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
|
PD-L1 expression • EGFR mutation
|
Hetronifly (serplulimab) • pimurutamab (HLX07)