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PM8002

DRUG13 trials

Sponsors

Biotheus Inc., Shanghai Pulmonary Hospital, Shanghai, China

Conditions

CRC (Colorectal Cancer)HCCHepatocellular CarcinomaLiver CancerLocally Advanced Non-Small Cell Lung CancerMPMMalignant NeoplasmNSCLC

Phase 1

PM8002 in the Treatment of Patients With Advanced Solid Tumors
RecruitingNCT05918445
Biotheus Inc.Malignant Neoplasm
Start: 2021-03-09End: 2025-11-30Target: 380Updated: 2024-12-05
A Study of PM8002 Plus Nab-paclitaxel as First Line Therapy for TNBC
Active, not recruitingNCT05918133
Biotheus Inc.TNBC
Start: 2022-07-01End: 2026-10-30Updated: 2025-03-11
A Study to Evaluate of PM8002 Combined With PM1009 in Patients With First-line HCC
Not yet recruitingNCT06584071
Biotheus Inc.HCC, Liver Cancer
Start: 2024-12-31End: 2027-12-31Target: 140Updated: 2024-12-16

Phase 2

A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With NSCLC
Active, not recruitingNCT05756972
Biotheus Inc.NSCLC
Start: 2023-06-26End: 2025-12-31Updated: 2025-04-03
A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With ES-SCLC
Active, not recruitingNCT05844150
Biotheus Inc.SCLC
Start: 2023-06-01End: 2025-12-31Updated: 2025-03-12
PM8002 in Combination With Chemotherapy as First Line Therapy in Hepatocellular Carcinoma
Active, not recruitingNCT05864105
Biotheus Inc.Hepatocellular Carcinoma
Start: 2022-04-22End: 2026-06-30Target: 35Updated: 2025-03-12
A Study of PM8002 in Combination With Chemotherapy in Patients With NEN
RecruitingNCT05879055
Biotheus Inc.Neuroendocrine Neoplasm
Start: 2023-05-17End: 2028-01-01Target: 60Updated: 2024-12-19
A Study of PM8002 in Combination With Chemotherapy in Patients With SCLC
Active, not recruitingNCT05879068
Biotheus Inc.SCLC
Start: 2022-05-27End: 2026-04-30Target: 99Updated: 2024-12-18
A Study of PM8002 Injection in Combination With Standard Chemotherapy as First Line Therapy in MPM
RecruitingNCT05918107
Biotheus Inc.MPM
Start: 2022-08-13End: 2026-06-30Target: 55Updated: 2023-06-27
Neoadjuvant Chemotherapy Combined With Bispecific Antibody Versus Monoclonal Antibody in Locally Advanced NSCLC
Not yet recruitingNCT06837948
Shanghai Pulmonary Hospital, Shanghai, ChinaLocally Advanced Non-Small Cell Lung Cancer
Start: 2025-02-18End: 2031-12-01Target: 160Updated: 2025-02-20
PM8002 (BNT327) in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer
Not yet recruitingNCT07133750
Biotheus Inc.CRC (Colorectal Cancer)
Start: 2025-08-31End: 2029-08-31Target: 40Updated: 2025-08-21

Phase 3

PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic TNBC
RecruitingNCT06419621
Biotheus Inc.Triple Negative Breast Cancer(TNBC)
Start: 2024-06-11End: 2028-07-31Target: 360Updated: 2025-03-12
PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in Small Cell Lung Cancer
RecruitingNCT06616532
Biotheus Inc.SCLC
Start: 2024-11-13End: 2028-12-25Target: 404Updated: 2024-12-19

Related Papers

PS5-09-20: A global Phase III, randomized, double-blind trial of BNT327 plus chemotherapy (chemo) vs placebo plus chemo in patients (pts) with previously untreated locally recurrent inoperable or metastatic, PD-L1 negative triple negative breast cancer (TNBC) (ROSETTA Breast-01)
Clinical Cancer Research2026-02-17
Abstract PS3-08: Interim Overall Survival of Patients with Locally Advanced or Metastatic Triple-Negative Breast Cancer treated with First Line PM8002/BNT327 in Combination with Nab-Paclitaxel in Phase Ib/II Study
Clinical Cancer Research2025-06-13
First report of efficacy and safety results from a phase 2 trial evaluating BNT327/PM8002 plus chemotherapy (chemo) as first-line treatment (1L) in unresectable malignant mesothelioma.
Journal of Clinical Oncology2025-05-28
A phase Ib/IIa trial to evaluate the safety and efficacy of PM8002, a bispecific antibody targeting PD-L1 and VEGF-A, as a monotherapy in patients with advanced NSCLC.
Journal of Clinical Oncology2024-06-019 citations
Efficacy and safety of PM8002, a bispecific antibody targeting PD-L1 and VEGF-A, as a monotherapy in patients with solid tumors: Clinical data from advanced cervical cancer and platinum-resistant recurrent ovarian cancer cohorts.
Journal of Clinical Oncology2024-06-013 citations